42 results on '"Lanzetta, P."'
Search Results
2. Vitrectomized vs non-vitrectomized eyes in DEX implant treatment for DMO-Is there any difference? the VITDEX study.
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Iglicki M, Busch C, Lanzetta P, Sarao V, Veritti D, Rassu N, Lupidi M, Cebeci Z, Fraser-Bell S, Bernal-Morales C, Sala-Puigdollers A, Zarranz-Ventura J, Gallego-Pinazo R, Maiti A, D'Amico Ricci G, Udaondo P, Loewenstein A, Chhablani J, and Zur D
- Subjects
- Humans, Glucocorticoids therapeutic use, Dexamethasone therapeutic use, Retrospective Studies, Drug Implants therapeutic use, Intravitreal Injections, Treatment Outcome, Macular Edema drug therapy, Macular Edema etiology, Macular Edema surgery, Diabetic Retinopathy drug therapy, Diabetic Retinopathy surgery
- Abstract
Objective: We aimed to compare visual and anatomical outcome in vitrectomized and non-vitrectomized eyes treated with dexamethasone (DEX) implant due to diabetic macular oedema (DMO)., Design: Multicenter, retrospective, interventional study., Participants: 236 eyes from 234 patients with DMO with or without previous vitrectomy performed with follow-up of 12 months., Methods: Records were reviewed for cases of DMO treated with DEX implant in vitrectomized and not vitrectomized eyes. Best corrected visual acuity (BCVA), central subfoveal thickness (CST), and intraocular pressure (IOP) were recorded at baseline and 12 months after treatment with DEX implants. Correlations between vitreous status and visual and anatomical outcome, as well as safety profile were analysed., Main Outcome Measures: BCVA and CST over follow-up period., Secondary Outcomes: cataract rate formation, intraocular pressure increase, number of implants needed., Results: The non-vitrectomized group included 130 eyes (55.1%), the vitrectomized group included 106 eyes (44.9%). The groups were well balanced for age and gender (p = 0.540, and p = 0.053, respectively). Both groups showed statistically significant improvement in BCVA and CST (for all groups: p < 0.001). There was no significant difference between the groups in terms of change in vision (p = 0.89) and anatomy (p = 0.65). The mean number of DEX implants given during follow-up was 3.5 in both groups, and there was no significant difference between the groups (p = 0.81)., Conclusion: We demonstrated similar anatomical and functional efficacy of DEX implant in non-vitrectomized and vitrectomized eyes. Its efficacy was not influenced by full vitrectomy for diabetic retinopathy complications. Safety profile was well balanced between groups., (© 2022. The Author(s), under exclusive licence to The Royal College of Ophthalmologists.)
- Published
- 2023
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3. Current role of intravitreal injections in Irvine Gass syndrome-CRIIG study.
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Sharma A, Bandello F, Loewenstein A, Kuppermann BD, Lanzetta P, Zur D, Hilely A, Iglicki M, Veritti D, Wang A, Miassi F, Bellocq D, Zacharias LC, Makam D, Kumar N, Parachuri N, Barriera AK, Sharma R, Faridi H, Mathis T, and Kodjikian L
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- Bevacizumab therapeutic use, Dexamethasone therapeutic use, Drug Implants, Glucocorticoids therapeutic use, Humans, India, Intravitreal Injections, Retrospective Studies, Visual Acuity, Macular Edema drug therapy
- Abstract
Objective: To analyze the role of intravitreal anti-vascular endothelial growth factor (anti-VEGF) or steroid injection for the management of Irvine Gass syndrome., Methods: It is an interventional, retrospective, multicenter study. One hundred and thirty-two injections were given in 79 eyes of 72 patients with Irvine Gass syndrome. Patients were treated with at least one intravitreal injection of either anti-VEGF or steroid. Outcomes were measured at 12 months (± 1 week). [Ranibizumab (Lucentis; Genentech, South San Francisco, CA) (Razumab; Intas Pharmaceutical Ltd, Ahmedabad, India) Bevacizumab (Avastin; Genentech, South San Francisco, CA) or Aflibercept (Eylea; Regeneron, Tarrytown, NY)] or steroids [Dexamethasone implant (Ozurdex, Allergan Inc, Irvine, CA) or intravitreal triamcinolone)]., Results: Intravitreal injections were initiated in (67.6%) of eyes within 14 weeks of diagnosis. Intravitreal dexamethasone implant was used as the initial intravitreal therapy in (73.4%) of eyes. More than fifty percent (54.5%) of the patients were switched from anti-VEGF to Intravitreal dexamethasone implant. Reduction in the mean CMT was 336.7 ± 191.7 and 160.1 ± 153.1 microns in eyes treated within four weeks and more than 14 weeks from diagnosis (p = 0.005). Mean ETDRS letter gain was 16.7 ± 12.9 and 5.2 ± 9.2 in eyes treated within 4 weeks and more than 14 weeks from diagnosis (p = 0.004). Three eyes injected with intravitreal dexamethasone implant reported an intraocular pressure spike of > 25 mmHg which was controlled with topical medications. No other ocular or systemic adverse events were observed., Conclusion: Study results suggest that physicians tend to introduce intravitreal therapy within 14 weeks of diagnosis. The most common therapy at initiation and for the switch is intravitreal dexamethasone implant. Patients treated early (within 4 weeks) respond better in terms of structure and function.
- Published
- 2020
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4. Intraocular pressure (IOP) after intravitreal dexamethasone implant (Ozurdex) amongst different geographic populations-GEODEX-IOP study.
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Sharma A, Kuppermann BD, Bandello F, Lanzetta P, Zur D, Park SW, Yu HG, Saravanan VR, Zacharias LC, Barreira AK, Iglicki M, Miassi F, Veritti D, Tsao S, Makam D, Jain N, and Loewenstein A
- Subjects
- Dexamethasone adverse effects, Drug Implants therapeutic use, Glucocorticoids adverse effects, Humans, India, Intraocular Pressure, Intravitreal Injections, Israel, Retrospective Studies, Tomography, Optical Coherence, Diabetic Retinopathy drug therapy, Macular Edema drug therapy, Macular Edema epidemiology, Retinal Vein Occlusion drug therapy
- Abstract
Purpose: To analyse the intraocular pressure rise after intravitreal dexamethasone implant (Ozurdex) amongst different geographic populations., Methods: The medical charts of 294 dexamethasone implants between February 2011 and 2017 were reviewed retrospectively. South Asian (India), White (Europe, US and Israel) Latino (Argentina and Brazil) patient data was included in the study. Ocular hypertension (OHT) was defined as intraocular pressure of >25 mmHg or an increase of at least 10 mmHg from baseline. The main indications for treatment were diabetic macular edema (ME) (65.6%), retinal vein occlusion (26.5%), uveitis (7.8%)., Results: Amongst 294 intravitreal implants, ocular hypertension (>25 mmHg) was recorded in 0, 8 and 9.5% in White, Latino, and South Asian groups, respectively. However, IOP > 20 mmHg was recorded in 14%, 28% and 27% in White, Latino, and South Asian groups, respectively. Incidence of very high IOP (>35 mmHg) was lower in all geographical groups. It was 3% in Latino followed by 2% in South Asian group., Conclusion: Latino and South Asian groups have higher IOP rise compared to White population. Most patients with elevated IOP fluctuate between 20-25 mmHg.
- Published
- 2020
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5. Dexamethasone Implant Produces Better Outcomes than Oral Acetazolamide in Patients with Cystoid Macular Edema Secondary to Retinitis Pigmentosa.
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Veritti D, Sarao V, De Nadai K, Chizzolini M, Parmeggiani F, Perissin L, and Lanzetta P
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- Acetazolamide administration & dosage, Administration, Oral, Adult, Anti-Inflammatory Agents administration & dosage, Anti-Inflammatory Agents therapeutic use, Carbonic Anhydrase Inhibitors administration & dosage, Carbonic Anhydrase Inhibitors therapeutic use, Case-Control Studies, Dexamethasone administration & dosage, Drug Implants administration & dosage, Drug Implants therapeutic use, Female, Follow-Up Studies, Humans, Intravitreal Injections, Macular Edema diagnosis, Macular Edema etiology, Male, Middle Aged, Propensity Score, Prospective Studies, Retinitis Pigmentosa complications, Retinitis Pigmentosa diagnosis, Treatment Outcome, Acetazolamide therapeutic use, Dexamethasone therapeutic use, Macular Edema drug therapy, Retinitis Pigmentosa drug therapy, Visual Acuity drug effects
- Abstract
Purpose: To compare the clinical outcome of intravitreal dexamethasone implant versus oral acetazolamide in patients with cystoid macular edema (CME) secondary to retinitis pigmentosa (RP). Design: Multicenter, prospective, propensity-score-matched, comparative study. Methods: Eyes with RP and CME were treated either with intravitreal dexamethasone implant or with oral acetazolamide (500 mg/day). Patients were evaluated monthly and followed up for 12 months. Primary outcome measures were changes in central retinal thickness and best corrected visual acuity (BCVA). Adverse events were recorded. Results: Propensity score matching resulted in 2 groups of 30 eyes each. All patients completed 12 months of follow-up. Mean central retinal thickness decreased from 535 μm at baseline to 208 μm at month 12 in the dexamethasone implant group and from 519 to 339 μm in the oral acetazolamide group ( P < 0.001, Student's t -test). Mean BCVA average change from baseline during the study (area-under-the-curve approach) was -0.084 logarithm of the minimum angle of resolution (logMAR) (+4.2 letters) in the dexamethasone implant group and -0.032 (+1.6 letters) in the oral acetazolamide group ( P < 0.05, Mann-Whitney U test). Patients in the dexamethasone implant group required on average 1.7 treatments during 1 year of therapy. Conclusions: In this study, intravitreal dexamethasone implant produced better anatomic and functional improvements over oral acetazolamide in patients affected by CME secondary to RP. Larger, randomized clinical trials with longer follow-up are warranted to confirm these data.
- Published
- 2020
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6. A Collaborative Retrospective Study on the Efficacy and Safety of Intravitreal Dexamethasone Implant (Ozurdex) in Patients with Diabetic Macular Edema: The European DME Registry Study.
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Rosenblatt A, Udaondo P, Cunha-Vaz J, Sivaprasad S, Bandello F, Lanzetta P, Kodjikian L, Goldstein M, Habot-Wilner Z, and Loewenstein A
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- Adult, Aged, Female, Humans, Intravitreal Injections, Male, Middle Aged, Retrospective Studies, Visual Acuity, Dexamethasone administration & dosage, Diabetic Retinopathy drug therapy, Drug Implants therapeutic use, Glucocorticoids administration & dosage, Macular Edema drug therapy
- Abstract
Purpose: To evaluate the efficacy, effect profile, and safety of dexamethasone implant on diabetic macular edema (DME) in a real-life setting, further comparing results by DME duration, previous treatment status, and diabetic control., Design: A multicenter, retrospective cohort of 340 DME eyes of 287 patients from 25 clinical sites from 8 countries., Methods: Data were analyzed in 2 perspectives: per injection, in which all measurements were grouped and baseline was defined as the day of injection, and thus the pharmacodynamics of single injections could be assessed; and injection series, defined as 2 or more injections with 3 to 6 months between injections analyzing the outcome 3 to 6 months after the last injection., Main Outcome Measures: Primary outcome was improvement of 15 or more letters in best-corrected visual acuity (BCVA) from baseline. Secondary outcomes included improvement of 10 letters or more in BCVA, change in central macular thickness (CMT), and time to maximum improvement and safety., Results: Overall, 762 injections were administered to 340 eyes of 287 patients. Injection series analysis included 171 series in 171 eyes of 150 patients, for a total of 444 injections, with a mean follow-up of 1.7±0.8 years. Of the 762 injections analyzed per injection, 22.7% achieved a 15-letter or more improvement, and 37.8% achieved a 10-letter or more improvement. Mean time to peak improvement was 81.9±39.7 days. Mean maximum change in CMT was -174±171 μm. Overall, 7.6% lost 15 or more letters. More eyes with early DME gained 10 or more letters and fewer eyes lost 10 or more letters compared with eyes with late DME (47.4% vs. 33.9% [P = 0.001] and 8.2% vs. 13.5% [P = 0.029], respectively). Patients with controlled diabetes showed greater CMT reduction (P = 0.0002). A higher percentage of treatment-naive patients gained 10 or 15 letter or more in BCVA (P = 0.001 and P = 0.006, respectively). Intraocular pressure elevation of more than 25 mmHg was found following 7.9% of injections; no endophthalmitis was reported., Conclusions: Dexamethasone implant is an effective and safe treatment for DME. Peak improvement was achieved 3 months after injection and dissipated thereafter. Clinicians and providers may consider shortening treatment intervals., (Copyright © 2019 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)
- Published
- 2020
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7. Pharmacotherapeutic management of macular edema in diabetic subjects undergoing cataract surgery.
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Sarao V, Veritti D, Maurutto E, Rassu N, Borrelli E, Loewenstein A, Sadda S, and Lanzetta P
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- Anti-Inflammatory Agents, Non-Steroidal pharmacokinetics, Bevacizumab pharmacokinetics, Bevacizumab therapeutic use, Cataract Extraction adverse effects, Humans, Hyperglycemia diagnosis, Hyperglycemia etiology, Hyperglycemia metabolism, Macular Edema complications, Macular Edema diagnosis, Macular Edema pathology, Phacoemulsification, Steroids therapeutic use, Anti-Inflammatory Agents, Non-Steroidal therapeutic use, Macular Edema drug therapy
- Abstract
Introduction: Cataracts and diabetes are widespread pathologies that are of growing concern to the global population. In diabetic patients who have had cataract surgery, the worsening of preexisting diabetic macular edema or occurrence of pseudophakic cystoid macular edema are common causes of visual impairment even with the most advanced surgical techniques available today for phacoemulsification., Areas Covered: In this review, the authors assess the available literature to evaluate and compare different drugs, with the aim of establishing the best pharmacological strategies for the prevention and treatment of macular edema in diabetic patients undergoing cataract surgery., Expert Opinion: Guidelines for the optimal management of diabetic macular edema in conjunction with cataract surgery or treatment of pseudophakic cystoid macular edema in diabetic patients are still lacking. To treat these conditions, clinicians need to understand the pharmacokinetics, posology, and efficacy of available drugs: topical non-steroidal anti-inflammatory drugs (NSAIDs), intravitreal anti-vascular endothelial growth factors (VEGFs), and both topical and intravitreal steroids. Diabetic patients undergoing cataract surgery should receive topical NSAIDs to prevent pseudophakic cystoid macular edema. Intravitreal anti-VEGFs and steroids, in association with cataract surgery, are indicated for patients with preexisting diabetic macular edema or those at high risk of macular edema after surgery.
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- 2018
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8. Aflibercept in the Treatment of Diabetic Macular Edema: A Review and Consensus Paper.
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Avitabile T, Azzolini C, Bandello F, Boscia F, De Falco S, Fornasari D, Lanzetta P, Mastropasqua L, Midena E, Ricci F, Staurenghi G, and Varano M
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- Diabetic Retinopathy physiopathology, Female, Humans, Intravitreal Injections, Macular Edema physiopathology, Male, Middle Aged, Surveys and Questionnaires, Vascular Endothelial Growth Factor A antagonists & inhibitors, Visual Acuity physiology, Angiogenesis Inhibitors therapeutic use, Diabetic Retinopathy drug therapy, Macular Edema drug therapy, Receptors, Vascular Endothelial Growth Factor therapeutic use, Recombinant Fusion Proteins therapeutic use
- Abstract
Purpose: To reach a consensus, among experts, on the role of aflibercept in diabetic macular edema (DME) through literature review., Methods: Two round tables, involving 12 Italian experts, were organized: in the first one, 6 pharmacologic and clinical questions were selected and analyzed by a systematic literature review, using a population, intervention, control, and outcomes framework; in the second one, the nominal group technique was used to discuss relevant evidence related to each question. The consensus was assessed using the 5-point Delphi score., Results: Agreement on statements was reached on 6/6 questions. The final statements were as follows: 1) High levels of both vascular endothelial growth factor (VEGF) and placental growth factor play an important role in the pathogenesis of DME. 2) The aflibercept pharmacologic profile is notably different from that of other anti-VEGF. 3) Aflibercept significantly improves functional and anatomical outcomes, and rapidly improves best-corrected visual acuity up to its peak; these results remain stable over time. 4) Diabetic macular edema aflibercept treatment requires a 5-monthly injection loading phase. Alternatively, a personalized pro re nata (PRN) regimen based on monthly monitoring and strict retreatment criteria can be used. 5) As an alternative to the bimonthly fixed regimen, in the maintenance phase the treatment schedule may be a PRN regimen with strict retreatment criteria or a treat and extend regimen. 6) No concerns on aflibercept ocular and systemic safety emerged from the literature., Conclusions: Consensus was reached among experts on how to best treat patients with DME with aflibercept.
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- 2017
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9. Fluocinolone acetonide for the treatment of diabetic macular edema.
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Veritti D, Sarao V, Diplotti L, Samassa F, and Lanzetta P
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- Cataract chemically induced, Fluocinolone Acetonide adverse effects, Fluocinolone Acetonide therapeutic use, Glaucoma chemically induced, Glucocorticoids therapeutic use, Humans, Intravitreal Injections, Visual Acuity drug effects, Diabetic Retinopathy drug therapy, Drug Implants, Fluocinolone Acetonide administration & dosage, Macular Edema drug therapy
- Abstract
Introduction: Fluocinolone acetonide intravitreal implant is a non-erodible implant approved for the treatment of diabetic macular edema (DME) insufficiently responsive to available therapies. Areas covered: The injectable intravitreal implant releases fluocinolone acetonide at an average rate of 0.2 µg/day for at least 36 months. The two pooled pivotal FAME trials showed that, in patients with DME previously treated with laser photocoagulation, fluocinolone acetonide intravitreal implant was more beneficial than sham injection when looking at the proportion of patients with an improvement from baseline in visual acuity of more than 15 letters at 24 months and at 36 months. Cataract (82%) and intraocular pressure (IOP) elevation (37%) were the most common adverse events. Raised IOP was mostly treated with IOP-lowering medications, with <5% of eyes requiring incisional IOP-lowering surgery. FAME trial program results are confirmed by a series of real-world studies in eyes with chronic/recalcitrant DME. Expert opinion: data indicate that fluocinolone acetonide intravitreal implant is a useful second-line option for the treatment of DME.
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- 2017
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10. Dexamethasone implant with fixed or individualized regimen in the treatment of diabetic macular oedema: six-month outcomes of the UDBASA study.
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Sarao V, Veritti D, Furino C, Giancipoli E, Alessio G, Boscia F, and Lanzetta P
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- Adult, Aged, Aged, 80 and over, Diabetic Retinopathy diagnosis, Diabetic Retinopathy drug therapy, Drug Implants, Female, Follow-Up Studies, Glucocorticoids administration & dosage, Humans, Intravitreal Injections, Macula Lutea pathology, Macular Edema diagnosis, Macular Edema etiology, Male, Middle Aged, Prospective Studies, Time Factors, Tomography, Optical Coherence, Treatment Outcome, Dexamethasone administration & dosage, Diabetic Retinopathy complications, Macular Edema drug therapy, Visual Acuity
- Abstract
Purpose: To evaluate a pro re nata administration of Ozurdex
® implant versus a single administration for treating diabetic macular oedema (DME)., Methods: This exploratory study is designed as a comparative, multicentre, randomized study with a follow-up of 6 months. Patients with DME were assigned to treatment at baseline either with a single Ozurdex® implant during the entire six-month follow-up (fixed group) or Ozurdex® implant followed by retreatment on an individualized basis (PRN group). Patients were scheduled for monthly evaluation based on assessment of best-corrected visual acuity (BCVA) and optical coherence tomography., Results: Twenty eyes were enrolled to the PRN group, and 22 were included in the fixed group. Following an equally steady, initial gain up to month 1, and maintenance up to month 3, vision started to decline in the fixed regimen group. At 6 months, a difference of 0.11 logMAR in BCVA was observed in favour of the PRN group. Compared to baseline, a significant reduction in retinal thickness was achieved up to month 2, when the fixed regimen group had begun to revert to pretreatment level. At 4 and 5 months, the difference in thickness between the two groups was statistically significant (p < 0.05). Mean number of treatments was 1.6 in the PRN group. Both fixed and PRN administration of Ozurdex showed a good safety profile., Conclusion: A personalized treatment with monthly monitoring and retreatment as needed is effective in maintaining functional and anatomical benefits of Ozurdex® ., (© 2017 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.)- Published
- 2017
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11. Early Effects of Dexamethasone Implant on Macular Morphology and Visual Function in Patients with Diabetic Macular Edema.
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Veritti D, Sarao V, Galiazzo F, and Lanzetta P
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- Aged, Diabetic Retinopathy complications, Diabetic Retinopathy diagnosis, Drug Implants, Female, Follow-Up Studies, Glucocorticoids administration & dosage, Humans, Intravitreal Injections, Macular Edema diagnosis, Macular Edema etiology, Male, Prospective Studies, Time Factors, Treatment Outcome, Dexamethasone administration & dosage, Diabetic Retinopathy drug therapy, Macula Lutea pathology, Macular Edema drug therapy, Tomography, Optical Coherence methods, Visual Acuity
- Abstract
Purpose: To evaluate the early effects of dexamethasone implant in patients with diabetic macular edema (DME)., Methods: Eyes with DME were prospectively included in the study. Best-corrected visual acuity (BCVA) measurement, complete ophthalmic evaluation, and spectral-domain optical coherence tomography were performed at baseline and 1, 2, 3, 7, 14, 21, 28, 60, and 90 days after treatment., Results: Twenty-three eyes of 20 patients were included in the study. Mean central retinal thickness (CRT) decreased rapidly after treatment (p < 0.0001, repeated measures ANOVA) from 511 μm at baseline to 469 μm after 1 day (p < 0.05), and 275 μm (p < 0.01) at the end of the follow-up. BCVA gain (p < 0.0001, repeated measures ANOVA) was on average +2 ETDRS letters at day 1 (not significant), +9 letters from day 28 to day 90 (p < 0.01)., Conclusion: Intravitreal dexamethasone implant showed an early and fast effect in reducing CRT and improving BCVA in DME patients., (© 2017 S. Karger AG, Basel.)
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- 2017
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12. Diabetic Macular Edema.
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Bandello F, Battaglia Parodi M, Lanzetta P, Loewenstein A, Massin P, Menchini F, and Veritti D
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- Diabetic Retinopathy epidemiology, Diabetic Retinopathy therapy, Global Health, Humans, Incidence, Prevalence, Risk Factors, Diabetic Retinopathy diagnosis, Disease Management, Macular Edema diagnosis, Macular Edema epidemiology, Macular Edema therapy, Tomography, Optical Coherence methods
- Abstract
Diabetic macular edema (DME), defined as a retinal thickening involving or approaching the center of the macula, represents the most common cause of vision loss in patients affected by diabetes mellitus. In the last few years, many diagnostic tools have proven to be useful in the detection and the monitoring of the features characterizing DME. On the other hand, several therapeutic approaches can now be proposed on the basis of the DME-specific characteristics. The aim of the present chapter is to thoroughly delineate the clinical and morphofunctional characteristics of DME and its current treatment perspectives. The pathogenesis and the course of DME require a complex approach with multidisciplinary intervention both at the systemic and local levels., (© 2017 S. Karger AG, Basel.)
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- 2017
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13. Recommendations for the appropriate management of diabetic macular edema: Light on DME survey and consensus document by an expert panel.
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Bandello F, Midena E, Menchini U, and Lanzetta P
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- Angiogenesis Inhibitors therapeutic use, Fluorescein Angiography, Humans, Intravitreal Injections, Laser Coagulation, Surveys and Questionnaires, Tomography, Optical Coherence, Vascular Endothelial Growth Factor A antagonists & inhibitors, Visual Acuity physiology, Diabetic Retinopathy diagnosis, Diabetic Retinopathy therapy, Macular Edema diagnosis, Macular Edema therapy
- Abstract
Purpose: The Light on DME survey was designed to address several issues concerning the management of diabetic macular edema (DME) with the objective of producing practical recommendations for the appropriate treatment of this condition., Methods: The recommendations considered aspects of DME treatment that are controversial and insufficiently supported by the evidence and were based on a consensus reached by an expert panel. Consensus was achieved by means of the Delphi method. Thirty-one Italian retinologists were asked to rate the appropriateness of a comprehensive set of scenarios typically encountered in the management of DME in clinical practice. The results of the appropriateness evaluation were analyzed by the study panel and a second assessment round was conducted for those scenarios on which no consensus was reached., Results: Consensus was reached on several relevant aspects of current DME management, namely the initiation and course of treatment with anti-vascular endothelial growth factor (VEGF) therapy, assessment of the outcomes of anti-VEGF therapy based on both functional and morphologic outcomes, combination of anti-VEGF with laser therapy, and management of nonresponders to anti-VEGFs. A few issues, including the definition of DME based on novel diagnostic tools, the need for stable metabolic parameters before initiating anti-VEGF therapy, and the use of a second anti-VEFG after failure of the first anti-VEGF, proved controversial., Conclusions: A clear consensus among DME experts was reached on several relevant aspects of DME management. Based on this consensus, detailed and practical recommendations to guide ophthalmologists in the use of novel approaches to DME could be developed.
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- 2016
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14. Dexamethasone implant in diabetic macular edema in real-life situations.
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Chhablani J, Bansal P, Veritti D, Sambhana S, Sarao V, Pichi F, Carrai P, Massaro D, Lembo A, Mansour AM, Banker A, Gupta SR, Hamam R, and Lanzetta P
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- Aged, Diabetic Retinopathy diagnosis, Diabetic Retinopathy physiopathology, Female, Fluorescein Angiography, Follow-Up Studies, Humans, Intraocular Pressure, Intravitreal Injections, Macular Edema diagnosis, Macular Edema physiopathology, Male, Middle Aged, Retrospective Studies, Tomography, Optical Coherence, Visual Acuity drug effects, Dexamethasone administration & dosage, Diabetic Retinopathy drug therapy, Drug Implants, Glucocorticoids administration & dosage, Macular Edema drug therapy
- Abstract
Purpose: To report outcome of eyes with recalcitrant and naive eyes with diabetic macular edema (DME) treated with intravitreal dexamethasone implants (Ozurdex) injection., Methods: Retrospective multicenter data analysis of eyes with DME treated with Ozurdex implant and with minimum follow-up of at least one year after the first implant. Data collected included demographic details, history of presenting illness, past treatment history, clinical examination details including visual acuity at presentation, and follow-up with imaging and treatment details. Paired sample t-test was used to measure mean differences between pre- and post-implant values obtained at baseline and last follow-up., Results: A total of 79 eyes (62 subjects) were included. Sixty-four eyes had been previously treated; 15 eyes were naive. Among the previously treated eyes, mean interval between first Ozurdex injection and any previous treatment was 7.69±8.2 months. In naive eyes, the visual acuity improved from baseline 0.58±0.25 to 0.44±0.33 logMAR at last follow-up (P=0.05). In eyes that had been previously treated, the improvement was from 0.65±0.34 at baseline to 0.48±0.35 logMAR (P=0.01). Mean treatment-free interval was 6.5±4.5 months. Nine eyes were steroid responder with controlled intraocular pressure (IOP), none showed any spike in IOP during the follow-up period., Conclusions: Ozurdex implant could be a good alternative for recalcitrant as well as naive eyes with DME. The visual gain after initial implant injection was fairly maintained, with additional treatment usually after 6 months in naive eyes. Ozurdex appeared safe even in steroid responders with good control of IOP with antiglaucoma medications.
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- 2016
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15. Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema: subgroup analysis of the MEAD study.
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Augustin AJ, Kuppermann BD, Lanzetta P, Loewenstein A, Li XY, Cui H, Hashad Y, and Whitcup SM
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- Aged, Angiogenesis Inhibitors therapeutic use, Dexamethasone adverse effects, Diabetic Retinopathy physiopathology, Drug Implants, Female, Glucocorticoids adverse effects, Humans, Immunosuppressive Agents therapeutic use, Intravitreal Injections, Macular Edema physiopathology, Male, Middle Aged, Retreatment, Tomography, Optical Coherence, Triamcinolone Acetonide therapeutic use, Vascular Endothelial Growth Factor A antagonists & inhibitors, Visual Acuity drug effects, Dexamethasone administration & dosage, Diabetic Retinopathy drug therapy, Glucocorticoids administration & dosage, Macular Edema drug therapy
- Abstract
Background: Dexamethasone intravitreal implant 0.7 mg (DEX 0.7) was approved for treatment of diabetic macular edema (DME) after demonstration of its efficacy and safety in the MEAD registration trials. We performed subgroup analysis of MEAD study results to evaluate the efficacy and safety of DEX 0.7 treatment in patients with previously treated DME., Methods: Three-year, randomized, sham-controlled phase 3 study in patients with DME, best-corrected visual acuity (BCVA) of 34-68 Early Treatment Diabetic Retinopathy Study letters (20/200-20/50 Snellen equivalent), and central retinal thickness (CRT) ≥ 300 μm measured by time-domain optical coherence tomography. Patients were randomized to 1 of 2 doses of DEX (0.7 mg or 0.35 mg), or to sham procedure, with retreatment no more than every 6 months. The primary endpoint was ≥ 15-letter gain in BCVA at study end. Average change in BCVA and CRT from baseline during the study (area-under-the-curve approach) and adverse events were also evaluated. The present subgroup analysis evaluated outcomes in patients randomized to DEX 0.7 (marketed dose) or sham based on prior treatment for DME at study entry., Results: Baseline characteristics of previously treated DEX 0.7 (n = 247) and sham (n = 261) patients were similar. In the previously treated subgroup, mean number of treatments over 3 years was 4.1 for DEX 0.7 and 3.2 for sham, 21.5% of DEX 0.7 patients versus 11.1 % of sham had ≥ 15-letter BCVA gain from baseline at study end (P = 0.002), mean average BCVA change from baseline was +3.2 letters with DEX 0.7 versus +1.5 letters with sham (P = 0.024), and mean average CRT change from baseline was -126.1 μm with DEX 0.7 versus -39.0 μm with sham (P < .001). Cataract-related adverse events were reported in 70.3% of baseline phakic patients in the previously treated DEX 0.7 subgroup; vision gains were restored following cataract surgery., Conclusions: DEX 0.7 significantly improved visual and anatomic outcomes in patients with DME previously treated with laser, intravitreal anti-vascular endothelial growth factor, intravitreal triamcinolone acetonide, or a combination of these therapies. The safety profile of DEX 0.7 in previously treated patients was similar to its safety profile in the total study population., Trial Registration: ClinicalTrials.gov NCT00168337 and NCT00168389, registered 12 September 2005.
- Published
- 2015
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16. TREAT-AND-EXTEND REGIMENS WITH ANTI-VEGF AGENTS IN RETINAL DISEASES: A Literature Review and Consensus Recommendations.
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Freund KB, Korobelnik JF, Devenyi R, Framme C, Galic J, Herbert E, Hoerauf H, Lanzetta P, Michels S, Mitchell P, Monés J, Regillo C, Tadayoni R, Talks J, and Wolf S
- Subjects
- Algorithms, Bevacizumab therapeutic use, Humans, Ranibizumab therapeutic use, Receptors, Vascular Endothelial Growth Factor therapeutic use, Recombinant Fusion Proteins therapeutic use, Angiogenesis Inhibitors therapeutic use, Diabetic Retinopathy drug therapy, Macular Degeneration drug therapy, Macular Edema drug therapy, Retinal Vein Occlusion drug therapy, Vascular Endothelial Growth Factor A antagonists & inhibitors
- Abstract
Purpose: A review of treat-and-extend regimens (TERs) with intravitreal anti-vascular endothelial growth factor agents in retinal diseases., Methods: There is a lack of consensus on the definition and optimal application of TER in clinical practice. This article describes the supporting evidence and subsequent development of a generic algorithm for TER dosing with anti-vascular endothelial growth factor agents, considering factors such as criteria for extension., Results: A TER algorithm was developed; TER is defined as an individualized proactive dosing regimen usually initiated by monthly injections until a maximal clinical response is observed (frequently determined by optical coherence tomography), followed by increasing intervals between injections (and evaluations) depending on disease activity. The TER regimen has emerged as an effective approach to tailoring the dosing regimen and for reducing treatment burden (visits and injections) compared with fixed monthly dosing or monthly visits with optical coherence tomography-guided regimens (as-needed or pro re nata). It is also considered a suitable approach in many retinal diseases managed with intravitreal anti-vascular endothelial growth factor therapy, given that all eyes differ in the need for repeat injections., Conclusion: It is hoped that this practical review and TER algorithm will be of benefit to health care professionals interested in the management of retinal diseases.
- Published
- 2015
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17. Author’s response.
- Author
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Sarao V, Bertoli F, Veritti D, and Lanzetta P
- Subjects
- Humans, Macular Edema drug therapy, Retinal Vein Occlusion drug therapy
- Published
- 2015
18. Pharmacotherapy for treatment of retinal vein occlusion.
- Author
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Sarao V, Bertoli F, Veritti D, and Lanzetta P
- Subjects
- Glucocorticoids therapeutic use, Humans, Macular Edema etiology, Randomized Controlled Trials as Topic, Retinal Vein Occlusion complications, Vascular Endothelial Growth Factor A antagonists & inhibitors, Macular Edema drug therapy, Retinal Vein Occlusion drug therapy
- Abstract
Introduction: Retinal vein occlusion (RVO) is a common vascular condition, which may cause blindness and impaired vision as a result of the development of macular oedema. The management of macular oedema due to RVO is complex and a multidisciplinary approach is required in order to limit disease progression and achieve a better clinical outcome., Areas Covered: An update and a brief review on the current treatment strategies were provided in patients with macular oedema following RVOs. Evidence available from prospective, multicentre clinical studies evaluating the use of VEGF inhibitors and steroids and from a selective literature search is reported., Expert Opinion: For many years, laser photocoagulation has been considered the standard of care for the treatment of branch RVO. However, new treatment modalities have been evaluated through randomised controlled trials. Recently, anti-VEGF agents and corticosteroids have been shown to be efficacious options in the treatment of RVO.
- Published
- 2014
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19. Three-year outcomes of individualized ranibizumab treatment in patients with diabetic macular edema: the RESTORE extension study.
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Schmidt-Erfurth U, Lang GE, Holz FG, Schlingemann RO, Lanzetta P, Massin P, Gerstner O, Bouazza AS, Shen H, Osborne A, and Mitchell P
- Subjects
- Angiogenesis Inhibitors adverse effects, Antibodies, Monoclonal, Humanized adverse effects, Diabetes Mellitus, Type 1 complications, Diabetes Mellitus, Type 2 complications, Diabetic Retinopathy physiopathology, Female, Humans, Intravitreal Injections, Laser Coagulation, Macular Edema physiopathology, Male, Middle Aged, Precision Medicine, Ranibizumab, Retina pathology, Retreatment, Sickness Impact Profile, Surveys and Questionnaires, Time Factors, Treatment Outcome, Visual Acuity physiology, Angiogenesis Inhibitors therapeutic use, Antibodies, Monoclonal, Humanized therapeutic use, Diabetic Retinopathy drug therapy, Macular Edema drug therapy
- Abstract
Objective: To evaluate long-term efficacy and safety profiles during 3 years of individualized ranibizumab treatment in patients with visual impairment due to diabetic macular edema (DME)., Design: Phase IIIb, multicenter, 12-month, randomized core study and 24-month open-label extension study., Participants: Of the 303 patients who completed the randomized RESTORE 12-month core study, 240 entered the extension study., Methods: In the extension study, patients were eligible to receive individualized ranibizumab treatment as of month 12 guided by best-corrected visual acuity (BCVA) and disease progression criteria at the investigators' discretion. Concomitant laser treatment was allowed according to the Early Treatment Diabetic Retinopathy Study guidelines. Based on the treatments received in the core study, the extension study groups were referred to as prior ranibizumab, prior ranibizumab + laser, and laser., Main Outcome Measures: Change in BCVA and incidence of ocular and nonocular adverse events (AEs) over 3 years., Results: Overall, 208 patients (86.7%) completed the extension study. In patients treated with ranibizumab during the core study, consecutive individualized ranibizumab treatment during the extension study led to an overall maintenance of BCVA and central retinal subfield thickness (CRST) observed at month 12 over the 2-year extension study (+8.0 letters, -142.1 μm [prior ranibizumab] and +6.7 letters, -145.9 μm [prior ranibizumab + laser] from baseline at month 36) with a median of 6.0 injections (mean, 6.8 injections; prior ranibizumab) and 4.0 (mean, 6.0 injections; prior ranibizumab + laser). In the prior laser group, a progressive BCVA improvement (+6.0 letters) and CRST reduction (-142.7 μm) at month 36 were observed after allowing ranibizumab during the extension study, with a median of 4.0 injections (mean, 6.5 injections) from months 12 to 35. Patients in all 3 treatment groups received a mean of <3 injections in the final year. No cases of endophthalmitis, retinal tear, or retinal detachment were reported. The most frequently reported ocular and nonocular adverse effects over 3 years were cataract (16.3%) and nasopharyngitis (23.3%). Eight deaths were reported during the extension study, but none were suspected to be related to the study drug/procedure., Conclusions: Ranibizumab was effective in improving and maintaining BCVA and CRST outcomes with a progressively declining number of injections over 3 years of individualized dosing. Ranibizumab was generally well tolerated with no new safety concerns over 3 years., (Copyright © 2014 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)
- Published
- 2014
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20. Retreatment with Ozurdex for macular edema secondary to retinal vein occlusion.
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Coscas G, Augustin A, Bandello F, de Smet MD, Lanzetta P, Staurenghi G, Parravano MC, Udaondo P, Moisseiev E, Soubrane G, Yatziv Y, and Loewenstein A
- Subjects
- Adult, Aged, Aged, 80 and over, Delayed-Action Preparations, Drug Implants, Female, Fluorescein Angiography, Humans, Injections, Intraocular, Macular Edema etiology, Male, Middle Aged, Retinal Vein Occlusion complications, Retreatment, Retrospective Studies, Treatment Outcome, Visual Acuity physiology, Dexamethasone administration & dosage, Glucocorticoids administration & dosage, Macular Edema drug therapy, Retinal Vein Occlusion drug therapy
- Abstract
Purpose: To review the current practice of retreatment with Ozurdex injections in patients with macular edema (ME) secondary to retinal vein occlusion (RVO), and to recommend simple guidelines for Ozurdex reinjection in management of RVO., Methods: This was a multicenter retrospective study of patients who received more than 2 Ozurdex injections for the treatment of ME in RVO. Recorded parameters included percent of patients with a 15-letter gain, visual acuity (VA) improvement from baseline, change in central macular thickness (CMT), time to reinjection, and occurrence of any complications., Results: A total of 128 patients were included, 58 (45.3%) with central RVO (CRVO) and 70 (54.7%) with branch RVO (BRVO). Mean interval for Ozurdex reinjection was 5.9 months following the first injection and 8.7 months following the second. A >15-letter gain in VA was observed in 34 (48.8%) patients with CRVO and 16 (28%) patients with BRVO. Mean overall VA improvement at month 6 did not show significance (p>0.05); however, a significantly better mean VA improvement was seen in treatment-naïve eyes (p<0.03). The CMT was significantly reduced compared to baseline. The mean CMT decreased by 214.6 µm in eyes with BRVO (n = 53) and by 355.1 µm in eyes with CRVO (n = 63) (p = 0.002). Complication rates were very low., Conclusions: Repeated injections of Ozurdex are effective and have a favorable safety profile. In current practice, the retreatment interval with Ozurdex injections might be too long, precluding the full therapeutic potential of this treatment modality. A strategy for managing RVO patients treated with Ozurdex on an as-needed basis is provided.
- Published
- 2014
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21. Regression of diabetic macular edema after subcutaneous exenatide.
- Author
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Sarao V, Veritti D, and Lanzetta P
- Subjects
- Exenatide, Female, Humans, Middle Aged, Diabetes Mellitus, Type 2 complications, Diabetic Retinopathy drug therapy, Hypoglycemic Agents administration & dosage, Macular Edema drug therapy, Peptides administration & dosage, Venoms administration & dosage
- Abstract
The aim of this study is to report a case of complete regression of diabetic macular edema after subcutaneous injection of exenatide in a patient with type 2 diabetes mellitus. This study is an interventional case report. Blood investigations, complete ophthalmic examinations and optical coherence tomography were performed. A 55-year-old female affected by poorly controlled type 2 diabetes mellitus presented with visual impairment due to macular edema in the right eye. The left eye showed mild edema without visual loss. Best-corrected visual acuity (BCVA) was 20/80 and 20/20, respectively. The patient was encouraged to improve metabolic control, and the antidiabetic therapy was modified combining exenatide 10 μg subcutaneously twice daily to her regimen of oral metformin. The patient did not receive any ocular treatment. A complete tomographic resolution of macular edema was observed after 1 month and BCVA improved to 20/63. These findings were confirmed for the entire 6-month follow-up duration. No ocular or non-ocular adverse events were recorded. This is the first reported case of complete regression of macular edema in a diabetic patient after subcutaneous injection of exenatide.
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- 2014
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22. Early effects of dexamethasone implant on macular morphology and visual function in patients with macular edema secondary to retinal vein occlusion.
- Author
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Veritti D, Macor S, and Lanzetta P
- Subjects
- Aged, Aged, 80 and over, Dexamethasone adverse effects, Drug Implants, Female, Glucocorticoids adverse effects, Humans, Intraocular Pressure drug effects, Macular Edema etiology, Macular Edema physiopathology, Male, Middle Aged, Prospective Studies, Retinal Vein Occlusion complications, Retinal Vein Occlusion physiopathology, Tomography, Optical Coherence, Vitreous Body, Dexamethasone administration & dosage, Glucocorticoids administration & dosage, Macular Edema drug therapy, Retina pathology, Retinal Vein Occlusion drug therapy, Visual Acuity physiology
- Abstract
Purpose: To evaluate the early effects of the intravitreal erodible dexamethasone implant Ozurdex in patients with macular edema due to retinal vein occlusion (RVO)., Methods: Eyes with macular edema due to RVO were prospectively included in the study and received a 700-μg dexamethasone implant. Best-corrected visual acuity (BCVA) measurement, complete ophthalmic evaluation and spectral-domain optical coherence tomography were performed at baseline and 1, 2, 3, 7, 14, 21, 28, 60, and 90 days after treatment., Results: Nineteen eyes of 18 patients were included in the study. Mean central retinal thickness (CRT) decreased rapidly after treatment (p < 0.0001) from 503 μm at baseline to 288 μm after 1 day and 199 μm at the end of the follow-up. BCVA gained on average +6 ETDRS letters after 1 day and +11 letters at day 90 (p = 0.0001)., Conclusion: The intravitreal dexamethasone implant showed a fast effect in reducing CRT and improving BCVA in RVO patients., (2014 S. Karger AG, Basel)
- Published
- 2014
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23. Effect of the duration of macular edema on clinical outcomes in retinal vein occlusion treated with dexamethasone intravitreal implant.
- Author
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Yeh WS, Haller JA, Lanzetta P, Kuppermann BD, Wong TY, Mitchell P, Whitcup SM, and Kowalski JW
- Subjects
- Aged, Double-Blind Method, Drug Implants, Female, Humans, Male, Middle Aged, Prospective Studies, Retinal Vein Occlusion physiopathology, Time Factors, Treatment Outcome, Visual Acuity physiology, Dexamethasone administration & dosage, Glucocorticoids administration & dosage, Macular Edema drug therapy, Macular Edema physiopathology, Retinal Vein Occlusion complications, Vitreous Body
- Abstract
Purpose: To assess the effect of duration of macular edema (ME) on clinical outcomes after treatment with dexamethasone intravitreal implant 0.7 mg (Ozurdex; Allergan, Inc, Irvine, CA) in patients with ME following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)., Design: Post hoc analysis of pooled data from 2 randomized, controlled trials., Participants: Patients with vision loss resulting from ME of 6 weeks' duration or more after BRVO or CRVO (n = 690)., Methods: The relationship between ME duration at the time of first treatment and treatment outcomes was assessed using logistic regression. Other factors potentially associated with ME duration or patient outcomes were adjusted for in the analyses., Main Outcome Measures: The proportion of patients achieving at least 15 letters improvement in best-corrected visual acuity (BCVA) or at least 200-μm or more reduction in central retinal thickness 6 or 12 months after the first treatment with dexamethasone intravitreal implant 0.7 mg., Results: In the 6-month analysis, each 1-month increase in ME duration was associated with a significantly lower likelihood of achieving a BCVA improvement of 15 letters or more (odds ratio [OR], 0.88; 95% confidence interval [CI], 0.83-0.94; P<0.001) or a CRT reduction of 200-μm or more (OR, 0.91; 95% CI, 0.86-0.97; P<0.01) 6 months after treatment. In the 12-month analysis, increased ME duration was associated with a significantly lower likelihood of achieving BCVA improvement of 15 letters or more improvement in BCVA (OR, 0.85; 95% CI, 0.76-0.95; P<0.01) 12 months after treatment; duration was not significantly associated with the likelihood of a CRT reduction of 200-μm or more at 12 months. In general, the effect of ME duration on outcomes was stronger and statistically significant in BRVO patients, but weaker and not statistically significant in CRVO patients., Conclusions: In eyes with retinal vein occlusion, longer ME duration at the time of first treatment with the dexamethasone intravitreal implant 0.7 mg was associated with a significantly lower likelihood of achieving clinically meaningful improvements in vision or CRT 6 or 12 months after treatment. This suggests that prompt treatment for retinal vein occlusion, particularly BRVO, may be associated with improved clinical outcomes., Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references., (Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)
- Published
- 2012
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24. Experience with the Pascal® photocoagulator: an analysis of over 1,200 laser procedures with regard to parameter refinement.
- Author
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Sheth S, Lanzetta P, Veritti D, Zucchiatti I, Savorgnani C, and Bandello F
- Subjects
- Automation, Humans, Laser Coagulation standards, Laser Coagulation statistics & numerical data, Normal Distribution, Retrospective Studies, Time Factors, White People, Diabetes Complications surgery, Diabetic Retinopathy surgery, Laser Coagulation instrumentation, Macular Edema surgery, Retinal Perforations surgery
- Abstract
Aim: To systematically refine and recommend parameter settings of spot size, power, and treatment duration using the Pascal® photocoagulator, a multi-spot, semi-automated, short-duration laser system., Materials and Methods: A retrospective consecutive series with 752 Caucasian eyes and 1242 laser procedures over two years were grouped into, (1) 374 macular focal / grid photocoagulation (FP), (2), 666 panretinal photocoagulation (PRP), and (3) 202 barrage photocoagulation (BP). Parameters for power, duration, spot number, and spot size were recorded for every group., Results: Power parameters for all groups showed a non-gaussian distribution; FP group, median 190 mW, range 100 - 950 mW, and PRP group, median 800 mW, range 100 - 2000 mW. On subgroup comparison, for similar spot size, as treatment duration decreased, the power required increased, albeit in a much lesser proportion than that given by energy = power x time. Most frequently used patterns were single spot (89% of cases) in FP, 5 Χ 5 box (72%) in PRP, and 2 Χ 2 box (78%) in BP. Spot diameters as high as ≈ 700 μm on retina were given in the PRP group. Single session PRP was attempted in six eyes with a median spot count of 3500., Conclusion: Overall, due to the small duration of its pulse, the Pascal® photocoagulator tends to use higher powers, although much lower cumulative energies, than those used in a conventional laser. The consequent lesser heat dissipation, especially lateral, can allow one to use relatively larger spot sizes and give more closely spaced burns, without incurring significant side effects.
- Published
- 2011
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25. Diabetic macular edema.
- Author
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Bandello F, Battaglia Parodi M, Lanzetta P, Loewenstein A, Massin P, Menchini F, and Veritti D
- Subjects
- Antibodies, Monoclonal, Humanized, Fluorescein Angiography, Fundus Oculi, Glucocorticoids administration & dosage, Humans, Intravitreal Injections, Ranibizumab, Tomography, Optical Coherence, Treatment Outcome, Antibodies, Monoclonal therapeutic use, Diabetic Retinopathy complications, Laser Coagulation methods, Macular Edema diagnosis, Macular Edema etiology, Macular Edema therapy, Triamcinolone Acetonide administration & dosage, Vitrectomy methods
- Abstract
Diabetic macular edema (DME), defined as a retinal thickening involving or approaching the center of the macula, represents the most common cause of vision loss in patients affected by diabetes mellitus. In the last few years, many diagnostic tools have been proven useful in the detection and the monitoring of the features characterizing DME. On the other hand, several therapeutic approaches can now be proposed on the basis of the DME-specific characteristics. The aim of the present chapter is to thoroughly delineate the clinical and morpho functional characteristics of DME and its current treatment perspectives. The pathogenesis and the course of DME require a complex approach with multidisciplinary intervention both at the systemic and local levels., (2010 S. Karger AG, Basel)
- Published
- 2010
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26. Posterior juxtascleral infusion of modified triamcinolone acetonide formulation for refractory diabetic macular edema: one-year follow-up.
- Author
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Veritti D, Lanzetta P, Perissin L, and Bandello F
- Subjects
- Aged, Chondroitin Sulfates adverse effects, Diabetic Retinopathy diagnosis, Diabetic Retinopathy physiopathology, Drug Therapy, Combination, Female, Fluorescein Angiography, Follow-Up Studies, Glucocorticoids adverse effects, Humans, Hyaluronic Acid adverse effects, Infusions, Parenteral, Macular Edema diagnosis, Macular Edema physiopathology, Male, Middle Aged, Prospective Studies, Sclera, Tomography, Optical Coherence, Treatment Outcome, Triamcinolone Acetonide adverse effects, Visual Acuity physiology, Chondroitin Sulfates administration & dosage, Diabetic Retinopathy drug therapy, Glucocorticoids administration & dosage, Hyaluronic Acid administration & dosage, Macular Edema drug therapy, Triamcinolone Acetonide administration & dosage
- Abstract
Purpose: To evaluate prospectively the efficacy and safety of posterior juxtascleral infusion of a new formulation of triamcinolone acetonide for refractory diffuse diabetic macular edema., Methods: This was an interventional case series. Twenty-two consecutive eyes of 18 patients with refractory diffuse diabetic macular edema were included in the study. Each patient underwent a complete ophthalmic examination, including optical coherence tomography (OCT) and digital fluorescein angiography (FA). All patients received a suspension of 40 mg triamcinolone acetonide, 20 mg sodium chondroitin sulfate, and 15 mg sodium hyaluronate (1.5 mL), delivered posteriorly through a conjunctival and Tenon's incision. All patients completed the 1-year follow-up., Results: On average, studied eyes received 1.5 treatments. Mean preoperative foveal thickness (+/-SD) and visual acuity (+/-SD) were 474.2 +/- 136.6 microm and 0.6 +/- 0.37 logarithm of the minimum angle of resolution (logMAR), respectively. The central foveal thickness was significantly reduced from baseline at every follow-up visit (P < 0.001). Mean (+/-SD) reductions in macular thickness were 136 +/- 108 microm at 1 week and 128 +/- 122 microm after 1 year of follow-up. Mean (+/-SD) improvement in visual acuity at 12 months was 0.15 +/- 0.21 logMAR (P = 0.008). Visual acuity improvement of one or more lines and three or more lines were observed in 14 (63.6%) and 6 (27.3%) eyes, respectively. Seven eyes (31.8%) required topical treatment due to a significant intraocular pressure increase., Conclusions: Posterior juxtascleral infusion of a new formulation of triamcinolone acetonide is an effective treatment for diffuse diabetic macular edema unresponsive to conventional grid laser photocoagulation. A randomized, larger study is warranted.
- Published
- 2009
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27. Pars plana vitrectomy for refractory diabetic macular edema.
- Author
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Grigorian R, Bhagat N, Lanzetta P, Tutela A, and Zarbin M
- Subjects
- Diabetic Retinopathy physiopathology, Humans, Vitrectomy adverse effects, Vitreous Body physiopathology, Diabetic Retinopathy complications, Macular Edema etiology, Macular Edema surgery, Vitrectomy methods
- Abstract
Objective: The aim of this study is to describe the results of pars plana vitrectomy (PPV) for refractory diabetic macular edema (DME)., Methods: Review of the relevant peer-reviewed scientific literature identified using Medline., Main Outcome Measures: The anatomical and functional outcome of surgery., Results: Vitrectomy with or without internal limiting membrane (ILM) peeling can be beneficial for the treatment of DME that is resistant to laser photocoagulation or sub-Tenon's steroid injection. Visual improvement has been reported in approximately 40-90% of patients, with approximately 85-100% experiencing either improvement or stabilization of vision. Retinal edema decreases or resolves in approximately 70-100% of patients. Complications range in severity with approximately 5-20% of patients developing peripheral retinal breaks, approximately 1-2% developing retinal detachment, approximately 2% developing macular hole, and approximately 10-60% developing cataract. Severe complications such as rubeosis iridis and the fibrinoid syndrome have also been reported., Conclusion: Pars plana vitrectomy can be an effective treatment for diabetic macular edema refractory to laser therapy and/or sub-Tenon's capsule steroid injection.
- Published
- 2003
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28. When and how to do a grid laser for diabetic macular edema.
- Author
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Bandello F, Lanzetta P, and Menchini U
- Subjects
- Blood-Retinal Barrier physiology, Diabetic Retinopathy chemically induced, Diabetic Retinopathy metabolism, Humans, Macula Lutea metabolism, Macula Lutea pathology, Macula Lutea surgery, Macular Edema etiology, Macular Edema metabolism, Pigment Epithelium of Eye metabolism, Pigment Epithelium of Eye pathology, Pigment Epithelium of Eye surgery, Treatment Outcome, Diabetic Retinopathy surgery, Laser Coagulation, Macular Edema surgery
- Abstract
Macular edema is a common feature of posterior segment diseases. It is an expression of abnormal permeability in either retinal vessels (inner blood-retinal barrier) or in the retinal pigment epithelium (outer blood-retinal barrier). It occurs in either a diffuse pattern where the macula appears generally thickened or, in more severe cases, as cystoid edema with the typical petaloid appearance. Grid laser treatment may be useful to reduce macular edema. Spots of 100-250 micrometers in diameter are applied to the whole posterior pole, one to two groups apart. The foveal avascular zone remains untouched. In patients treated bilaterally, areas temporal and nasal to the macula must be spared to prevent the development of deep scotomas. The mechanism yielding positive results with the grid technique is still debated. Among the most reliable hypotheses are: Proliferation of pigment epithelial cells, followed by and improved efficiency of the outer blood-retinal barrier; proliferation of endothelial cells in retinal capillaries followed by an improved efficiency of the inner blood-retinal barrier; improvement of the retinochoroidal exchanges, and finally, release by coagulative necrosis of a factor able to improve the efficiency of the blood-retinal barriers. Lasers with long wavelengths, such as krypton red and diode, are the most appropriate ones to perform grid treatment.
- Published
- 1999
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29. Intraocular pressure (IOP) after intravitreal dexamethasone implant (Ozurdex) amongst different geographic populations-GEODEX-IOP study.
- Author
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Bandello, Francesco, Lanzetta, Paolo, Zur, Dinah, Park, Sung, Yu, Hyeong, Saravanan, V, Zacharias, Leandro, Barreira, Alan, Iglicki, Matias, Miassi, Fernando, Veritti, Daniele, Tsao, Sean, Makam, Deepika, Jain, Nidhee, Loewenstein, Anat, Sharma, Ashish, and Kuppermann, Baruch
- Subjects
Dexamethasone ,Diabetic Retinopathy ,Drug Implants ,Glucocorticoids ,Humans ,India ,Intraocular Pressure ,Intravitreal Injections ,Israel ,Macular Edema ,Retinal Vein Occlusion ,Retrospective Studies ,Tomography ,Optical Coherence - Abstract
PURPOSE: To analyse the intraocular pressure rise after intravitreal dexamethasone implant (Ozurdex) amongst different geographic populations. METHODS: The medical charts of 294 dexamethasone implants between February 2011 and 2017 were reviewed retrospectively. South Asian (India), White (Europe, US and Israel) Latino (Argentina and Brazil) patient data was included in the study. Ocular hypertension (OHT) was defined as intraocular pressure of >25 mmHg or an increase of at least 10 mmHg from baseline. The main indications for treatment were diabetic macular edema (ME) (65.6%), retinal vein occlusion (26.5%), uveitis (7.8%). RESULTS: Amongst 294 intravitreal implants, ocular hypertension (>25 mmHg) was recorded in 0, 8 and 9.5% in White, Latino, and South Asian groups, respectively. However, IOP > 20 mmHg was recorded in 14%, 28% and 27% in White, Latino, and South Asian groups, respectively. Incidence of very high IOP (>35 mmHg) was lower in all geographical groups. It was 3% in Latino followed by 2% in South Asian group. CONCLUSION: Latino and South Asian groups have higher IOP rise compared to White population. Most patients with elevated IOP fluctuate between 20-25 mmHg.
- Published
- 2020
30. Is scleral fixation a safe procedure for intraocular lens implantation?
- Author
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Lanzetta, Paolo, Bandello, Francesco M., Virgili, Gianni, Crovato, Sabrina, and Menchini, Ugo
- Published
- 1999
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31. Long-term outcomes after intravitreal dexamethasone treatment in steroid responders
- Author
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Al-khersan, H., Hariprasad, S. M., Singh, S. R., Chhablani, J., Agarwal, K., Agrawal, K. U., Goel, N., Gupta, V., Jain, N. V., Lanzetta, P., Loewenstein, A., Modi, A., Rosenblatt, A., Sarao, V., Veritti, D., and Yadav, N. K.
- Subjects
Adult ,Male ,medicine.medical_specialty ,Intraocular pressure ,genetic structures ,Endocrinology, Diabetes and Metabolism ,medicine.medical_treatment ,Ocular hypertension ,030209 endocrinology & metabolism ,Vitrectomy ,030204 cardiovascular system & hematology ,Dexamethasone ,Macular Edema ,03 medical and health sciences ,Steroid-induced ocular hypertension ,0302 clinical medicine ,Endocrinology ,Refractory ,Diabetic macular edema ,Ophthalmology ,Diabetes mellitus ,Internal Medicine ,medicine ,Humans ,Intravitreal dexamethasone ,Adverse effect ,Intraocular Pressure ,Aged ,Drug Implants ,Optical coherence tomography ,Diabetic Retinopathy ,Female ,Middle Aged ,Ocular Hypertension ,Steroids ,business.industry ,General Medicine ,medicine.disease ,eye diseases ,sense organs ,Implant ,business ,medicine.drug - Abstract
Intravitreal steroid implants have emerged as an adjunctive therapy in diabetic macular edema (DME) in patients refractory to anti-vascular endothelial growth factor agents. However, the use of these agents in patients with a prior history of steroid-induced ocular hypertension is limited. The present study aimed to analyze long-term intraocular pressure (IOP) response to the dexamethasone implant in patients with DME and a history of steroid-induced increase in IOP. In a multicenter retrospective review, 17 eyes with DME and a history of steroid-induced increase in IOP to > 21 mmHg were treated with the dexamethasone implant and followed for 18 months. Patients with a history of vitrectomy of vitreoretinal interface pathology were excluded. The primary outcomes were the change in IOP and use of IOP-lowering agents. Among the study population (17 eyes), there was no significant change in mean IOP from baseline through 18 months (15.9 ± 2.0–14.6 ± 2.8 mmHg; p = 0.18). The number of patients requiring IOP-lowering agents rose from 5 at baseline to 14 at 18 months (p = 0.0049). None of the study eyes required surgical treatment. Though dexamethasone does predictably lead to an increase in IOP, this adverse effect was effectively managed with topical treatment. The present study suggests that the intravitreal dexamethasone implant may be considered in patients with DME and a history of steroid-induced ocular hypertension who have exhausted first-line treatments.
- Published
- 2019
32. Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema: Subgroup analysis of the MEAD study
- Author
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Augustin, A. J., Kuppermann, B. D., Lanzetta, P., Loewenstein, A., X. -Y., Li, Cui, H., Hashad, Y., Whitcup, S. M., Abujamra, S., Acton, J., Ali, F., Antoszyk, A., Awh, C. C., Barak, A., Bartz-Schmidt, K. U., Baumal, C. R., Belfort, R. Jr., Bhende, M., Boyer, D. S., Bridges, W. Z. Jr., Brown, D. M., Carmichael, T., Carnevale, K., Casella, A. M., Chang, T., Chechik, D., Chen, S. -N., Chong, L. P., Chong, V., Corwin, J., Creuzot-Garcher, C., Cruess, A., Daniell, M., De Avila, M. P., De Moraes, H. V. Jr., Devenyi, R. G., Doft, B. H., Donaldson, M., Dreyer, R., Eliott, D., Engel, H. M., Ernest, J., Essman, T. F., Falcone, P. M., Fekrat, S., Ferencz, J. R., Ferreira, J. L., Figueira, J., Fiser, I., Foster, B., Fox, G. M., Freeman, W. R., Garg, S. P., Gillies, M., Glaser, D., Goldstein, B. G., Gomes, A. M. V., Gonder, J. R., Gopal, L., Gous, P., Gupta, A., Halperin, L., Han, D., Hariprasad, S. M., Holz, F. G., Kaiser, P., Kalvodova, B., Katz, B., Katz, R. S., Kecik, D., Kellaway, J., Klemperer, I., Lattanzio, R., Lee, W. -K., Lehr, J., Leys, M., Loose, I., Lotery, A., D. -W., Lu, Mccartney, P., Majji, A. B., Martinez, J. A., Massin, P., Maturi, R. K., Menchini, U., Menon, G., Michels, M., Midena, E., Miller, J. Jr., Mitchell, P., Moisseiev, J., Morse, L., Navarro, R., Nemeth, J., Newland, H., Newsom, R., Nichols, J., Orellana, J., Orzalesi, N., Paranhos, A. Jr., Park, R., Park, S., Parodi, M. B., Pavan, P. R., Peace, J., Perez-Ortiz, D. J., Pollack, A., Ramaswamy, K., Ratnakaram, R., Ravalico, G., Rehak, J., Rezaei, K., Rizzo, S., Rodriguez-Alvira, F. J., Romanet, J. -P., Rose, S., Rosen, R. B., Rossetti, L., Ruiz-Moreno, J. M., Sadda, S., Sall, K., Sandner, D., Sanz, A. F. -V., Sartani, G., Schmickler, S., Schwartz, S. D., Sharma, Y. R., Sheu, S. -J., Singer, M., Sivaprasad, S., Soubrane, G., Soucek, P., Souied, E. H., Staurenghi, G., Studnicka, J., Suarez-Figueroa, M., Takahashi, W. Y., Tognetto, D., Tsai, P. L., Ulanski, L. J., H. S., Uy, Varano, M., Veith, M., Vicha, I., Viola, F., Visser, L., Weinberger, D., Wing, G. L., Wong, E., Wong, T. Y., Wylegala, E., Yan, J., Yoon, Y. H., Young, L. H., H. G., Yu, Zimmer-Galler, I. E., Augustin, Aj, Kuppermann, Bd, Lanzetta, P, Loewenstein, A, Li, Xy, Cui, H, Hashad, Y, Whitcup, Sm, on behalf of for the Ozurdex MEAD Study, Group, Battaglia Parodi, M, Augustin, A. J., Kuppermann, B. D., Lanzetta, P., Loewenstein, A., Li, X. -Y., Cui, H., Hashad, Y., Whitcup, S. M., Abujamra, S., Acton, J., Ali, F., Antoszyk, A., Awh, C. C., Barak, A., Bartz-Schmidt, K. U., Baumal, C. R., Belfort, R., Bhende, M., Boyer, D. S., Bridges, W. Z., Brown, D. M., Carmichael, T., Carnevale, K., Casella, A. M., Chang, T., Chechik, D., Chen, S. -N., Chong, L. P., Chong, V., Corwin, J., Creuzot-Garcher, C., Cruess, A., Daniell, M., De Avila, M. P., De Moraes, H. V., Devenyi, R. G., Doft, B. H., Donaldson, M., Dreyer, R., Eliott, D., Engel, H. M., Ernest, J., Essman, T. F., Falcone, P. M., Fekrat, S., Ferencz, J. R., Ferreira, J. L., Figueira, J., Fiser, I., Foster, B., Fox, G. M., Freeman, W. R., Garg, S. P., Gillies, M., Glaser, D., Goldstein, B. G., Gomes, A. M. V., Gonder, J. R., Gopal, L., Gous, P., Gupta, A., Halperin, L., Han, D., Hariprasad, S. M., Holz, F. G., Kaiser, P., Kalvodova, B., Katz, B., Katz, R. S., Kecik, D., Kellaway, J., Klemperer, I., Lattanzio, R., Lee, W. -K., Lehr, J., Leys, M., Loose, I., Lotery, A., Lu, D. -W., Mccartney, P., Majji, A. B., Martinez, J. A., Massin, P., Maturi, R. K., Menchini, U., Menon, G., Michels, M., Midena, E., Miller, J., Mitchell, P., Moisseiev, J., Morse, L., Navarro, R., Nemeth, J., Newland, H., Newsom, R., Nichols, J., Orellana, J., Orzalesi, N., Paranhos, A., Park, R., Park, S., Parodi, M. B., Pavan, P. R., Peace, J., Perez-Ortiz, D. J., Pollack, A., Ramaswamy, K., Ratnakaram, R., Ravalico, G., Rehak, J., Rezaei, K., Rizzo, S., Rodriguez-Alvira, F. J., Romanet, J. -P., Rose, S., Rosen, R. B., Rossetti, L., Ruiz-Moreno, J. M., Sadda, S., Sall, K., Sandner, D., Sanz, A. F. -V., Sartani, G., Schmickler, S., Schwartz, S. D., Sharma, Y. R., Sheu, S. -J., Singer, M., Sivaprasad, S., Soubrane, G., Soucek, P., Souied, E. H., Staurenghi, G., Studnicka, J., Suarez-Figueroa, M., Takahashi, W. Y., Tognetto, D., Tsai, P. L., Ulanski, L. J., Uy, H. S., Varano, M., Veith, M., Vicha, I., Viola, F., Visser, L., Weinberger, D., Wing, G. L., Wong, E., Wong, T. Y., Wylegala, E., Yan, J., Yoon, Y. H., Young, L. H., Yu, H. G., and Zimmer-Galler, I. E.
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Male ,Vascular Endothelial Growth Factor A ,Visual acuity ,Triamcinolone acetonide ,genetic structures ,medicine.medical_treatment ,Visual Acuity ,Angiogenesis Inhibitors ,Drug Implant ,Triamcinolone Acetonide ,Dexamethasone ,Immunosuppressive Agent ,Glucocorticoid ,Diabetic retinopathy ,Dexamethasone Intravitreal Implant ,Corticosteroid ,Drug delivery ,Implant ,Macular edema ,Aged ,Diabetic Retinopathy ,Drug Implants ,Female ,Glucocorticoids ,Humans ,Immunosuppressive Agents ,Intravitreal Injections ,Macular Edema ,Middle Aged ,Retreatment ,Tomography, Optical Coherence ,Ophthalmology ,Tomography ,General Medicine ,medicine.symptom ,medicine.drug ,Angiogenesis Inhibitor ,Human ,Research Article ,medicine.medical_specialty ,Subgroup analysis ,medicine ,business.industry ,Intravitreal Injection ,Cataract surgery ,medicine.disease ,eye diseases ,Optical Coherence ,business - Abstract
Dexamethasone intravitreal implant 0.7 mg (DEX 0.7) was approved for treatment of diabetic macular edema (DME) after demonstration of its efficacy and safety in the MEAD registration trials. We performed subgroup analysis of MEAD study results to evaluate the efficacy and safety of DEX 0.7 treatment in patients with previously treated DME. Three-year, randomized, sham-controlled phase 3 study in patients with DME, best-corrected visual acuity (BCVA) of 34–68 Early Treatment Diabetic Retinopathy Study letters (20/200–20/50 Snellen equivalent), and central retinal thickness (CRT) ≥300 μm measured by time-domain optical coherence tomography. Patients were randomized to 1 of 2 doses of DEX (0.7 mg or 0.35 mg), or to sham procedure, with retreatment no more than every 6 months. The primary endpoint was ≥15-letter gain in BCVA at study end. Average change in BCVA and CRT from baseline during the study (area-under-the-curve approach) and adverse events were also evaluated. The present subgroup analysis evaluated outcomes in patients randomized to DEX 0.7 (marketed dose) or sham based on prior treatment for DME at study entry. Baseline characteristics of previously treated DEX 0.7 (n = 247) and sham (n = 261) patients were similar. In the previously treated subgroup, mean number of treatments over 3 years was 4.1 for DEX 0.7 and 3.2 for sham, 21.5 % of DEX 0.7 patients versus 11.1 % of sham had ≥15-letter BCVA gain from baseline at study end (P = 0.002), mean average BCVA change from baseline was +3.2 letters with DEX 0.7 versus +1.5 letters with sham (P = 0.024), and mean average CRT change from baseline was −126.1 μm with DEX 0.7 versus −39.0 μm with sham (P
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- 2015
33. Fundamental principles of an effective diabetic retinopathy screening program
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Lanzetta, Paolo, Sarao, Valentina, Scanlon, Peter H, Barratt, Jane, Porta, Massimo, Bandello, Francesco, Loewenstein, Anat, Eldem, Bora, Hunyor, Alex, Joussen, Antonia, Koh, Adrian, Korobelnik, Jean-François, Lövestam-Adrian, Monica, Navarro, Rafael, Okada, Annabelle A., Pearce, Ian, Rodríguez, Francisco J., Staurenghi, Giovanni, Wolf, Sebastian, Wong, David T., Lanzetta, P., Sarao, V., Scanlon, P. H., Barratt, J., Porta, M., Bandello, F., Loewenstein, A., Eldem, B., Hunyor, A., Joussen, A., Koh, A., Korobelnik, J. -F., Lovestam-Adrian, M., Navarro, R., Okada, A. A., Pearce, I., Rodriguez, F. J., Staurenghi, G., Wolf, S., and Wong, D. T.
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Adult ,Male ,Telemedicine ,Consensus ,Endocrinology, Diabetes and Metabolism ,Diabetic macular edema ,Early detection ,030209 endocrinology & metabolism ,Macular Edema ,Diabetic retinopathy screening ,03 medical and health sciences ,0302 clinical medicine ,Endocrinology ,Evidence-based recommendations ,Internal Medicine ,medicine ,Diabetes Mellitus ,Humans ,Mass Screening ,Grading (education) ,Referral and Consultation ,Accreditation ,Diabetic Retinopathy ,business.industry ,General Medicine ,Diabetic retinopathy ,Middle Aged ,medicine.disease ,RA645.D54 ,Systematic review ,Practice Guidelines as Topic ,030221 ophthalmology & optometry ,RE ,Female ,Medical emergency ,business ,Program Evaluation - Abstract
Background Diabetic retinopathy (DR) is the leading cause of blindness among working-age adults worldwide. Early detection and treatment are necessary to forestall vision loss from DR. Methods A working group of ophthalmic and diabetes experts was established to develop a consensus on the key principles of an effective DR screening program. Recommendations are based on analysis of a structured literature review. Results The recommendations for implementing an effective DR screening program are: (1) Examination methods must be suitable for the screening region, and DR classification/grading systems must be systematic and uniformly applied. Two-field retinal imaging is sufficient for DR screening and is preferable to seven-field imaging, and referable DR should be well defined and reliably identifiable by qualified screening staff; (2) in many countries/regions, screening can and should take place outside the ophthalmology clinic; (3) screening staff should be accredited and show evidence of ongoing training; (4) screening programs should adhere to relevant national quality assurance standards; (5) studies that use uniform definitions of risk to determine optimum risk-based screening intervals are required; (6) technology infrastructure should be in place to ensure that high-quality images can be stored securely to protect patient information; (7) although screening for diabetic macular edema (DME) in conjunction with DR evaluations may have merit, there is currently insufficient evidence to support implementation of programs solely for DME screening. Conclusion Use of these recommendations may yield more effective DR screening programs that reduce the risk of vision loss worldwide.
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- 2020
34. An optical coherence tomography-based grading of diabetic maculopathy proposed by an international expert panel: The European School for Advanced Studies in Ophthalmology classification
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Maria Vittoria Cicinelli, Ursula Schmidt-Erfurth, Sobha Sivaprasad, Gianni Virgili, José Cunha-Vaz, Giuseppe Guarnaccia, Edoardo Midena, Laurent Kodjikian, Lee M. Jampol, Monica Varano, Maurizio Battaglia Parodi, Albert J. Augustin, Federico Ricci, Giuseppe Querques, Anselm Jünemann, Rafael Navarro, Paolo Lanzetta, Anat Lowenstein, Rufino Silva, Francesco Bandello, Giacomo Panozzo, Panozzo, G., Cicinelli, M. V., Augustin, A. J., Battaglia Parodi, M., Cunha-Vaz, J., Guarnaccia, G., Kodjikian, L., Jampol, L. M., Junemann, A., Lanzetta, P., Lowenstein, A., Midena, E., Navarro, R., Querques, G., Ricci, F., Schmidt-Erfurth, U., da Silva, R. M., Sivaprasad, S., Varano, M., Virgili, G., and Bandello, F.
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Male ,Classification ,consensus ,diabetic macular edema ,diabetic maculopathy ,optical coherence tomography ,vitreomacular interface ,Consensus ,Computer science ,Consensu ,Spectral domain ,Macular Edema ,Optical coherence tomography ,International Classification of Diseases ,Settore MED/30 ,Aged ,Diabetic Retinopathy ,Europe ,Female ,Humans ,Middle Aged ,Tomography, Optical Coherence ,International Classification of Disease ,Medical imaging ,medicine ,Grading (tumors) ,Tomography ,Retina detachment ,medicine.diagnostic_test ,Disease classification ,General Medicine ,Diabetic retinopathy ,medicine.disease ,Diabetic maculopathy ,Ophthalmology ,Optical Coherence ,Optometry ,Human - Abstract
Aims:To present an authoritative, universal, easy-to-use morphologic classification of diabetic maculopathy based on spectral domain optical coherence tomography.Methods:The first draft of the project was developed based on previously published classifications and a literature search regarding the spectral domain optical coherence tomography quantitative and qualitative features of diabetic maculopathy. This draft was sent to an international panel of retina experts for a first revision. The panel met at the European School for Advanced Studies in Ophthalmology headquarters in Lugano, Switzerland, and elaborated the final document.Results:Seven tomographic qualitative and quantitative features are taken into account and scored according to a grading protocol termed TCED-HFV, which includes foveal thickness (T), corresponding to either central subfoveal thickness or macular volume, intraretinal cysts (C), the ellipsoid zone (EZ) and/or external limiting membrane (ELM) status (E), presence of disorganization of the inner retinal layers (D), number of hyperreflective foci (H), subfoveal fluid (F), and vitreoretinal relationship (V). Four different stages of the disease, that is, early diabetic maculopathy, advanced diabetic maculopathy, severe diabetic maculopathy, and atrophic maculopathy, are based on the first four variables, namely the T, C, E, and D. The different stages reflect progressive severity of the disease.Conclusion:A novel grading system of diabetic maculopathy is hereby proposed. The classification is aimed at providing a simple, direct, objective tool to classify diabetic maculopathy (irrespective to the treatment status) even for non-retinal experts and can be used for therapeutic and prognostic purposes, as well as for correct evaluation and reproducibility of clinical investigations.
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- 2019
35. Safety of 6000 intravitreal dexamethasone implants
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Singh, Sumit Randhir, Raji, K., Wong, J. S., Al-Khersan, Hasenin, Bandello, Francesco, Giancipoli, Ermete, Novais, Eduardo, Masarwa, Dua, Wu, Lihteh, Okada, Mali, Nagpal, Manish, Casella, Marcelo, Lupidi, Marco, Avila, Marcos, Berrocal, Maria, Zur, Dinah, Veritti, Daniele, Sarvaiya, Chintan, Bernal-Morales, Carolina, Cagini, Carlo, Sharma, Ashish, Sala-Puigdollers, Anna, Maiti, Aniruddha, Maia, Andre, Marashi, Ameen, Sen, Alok C., Banker, Alay, Mansour, Ahmad, Goud, Abhilash, Singh, A., Gupta, A., Chhablani, Jay, Kodjikian, Laurent, Arevalo, J. Fernando, Lanzetta, Paolo, Farah, Michel Eid, Querques, Giuseppe, Udaondo Mirete, Patricia, Mishra, Sanjay Kumar, Sarao, Valentina, Iglicki, Matias, Maia, Mauricio, Cavalleri, Michele, Rasheed, Mohammed Abdul, Asencio-Duran, Monica, Rassu, Nicolo, D'Anna-Mardero, Oriana, Gabrielle, Pierre-Henry, Shenoy, Prateek, Gallego-Pinazo, Roberto, Dolz Marco, Rosa, Kumar, S., Patyal, S., Fraser-Bell, Samantha, Cohen, Shai, Sharma, V., Chaikitmongkol, Voraporn, Cebeci, Zafer, AYHAN, ZİYA, Al-khersan, Hasenin, SAATCİ, ALİ OSMAN, Rodriguez-Valdes, Patricio J., Sahoo, Niroj Kumar, Busch, Catharina, Fung, Adrian T., Zarranz-Ventura, Javier, Rajesh, Bindu, Ayhan, Ziya, Matériaux, ingénierie et science [Villeurbanne] (MATEIS), Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Institut National des Sciences Appliquées (INSA)-Université de Lyon-Institut National des Sciences Appliquées (INSA), L V Prasad Eye Institute, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Rajesh, B., Zarranz-Ventura, J., Fung, A. T., Busch, C., Sahoo, N. K., Rodriguez-Valdes, P. J., Sarao, V., Mishra, S. K., Saatci, A. O., Udaondo Mirete, P., Querques, G., Farah, M. E., Lanzetta, P., Arevalo, J. F., Kodjikian, L., and Chhablani, J.
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Male ,Intraocular pressure ,Visual acuity ,genetic structures ,Glaucoma ,drugs ,Dexamethasone ,[SPI.MAT]Engineering Sciences [physics]/Materials ,chemistry.chemical_compound ,0302 clinical medicine ,Endophthalmitis ,Drug Implants ,drug ,Retinal detachment ,Middle Aged ,Sensory Systems ,3. Good health ,Intravitreal Injections ,Disease Progression ,Female ,medicine.symptom ,treatment medical ,medicine.drug ,medicine.medical_specialty ,vision ,Cataract ,Macular Edema ,vitreous ,03 medical and health sciences ,Cellular and Molecular Neuroscience ,Retinal Diseases ,Ophthalmology ,Retinal Vein Occlusion ,medicine ,Humans ,Glucocorticoids ,Aged ,Retrospective Studies ,business.industry ,Retinal ,Uveitis, Posterior ,medicine.disease ,eye diseases ,chemistry ,030221 ophthalmology & optometry ,Implant ,sense organs ,business ,030217 neurology & neurosurgery - Abstract
PurposeTo evaluate the real-life safety profile of intravitreal dexamethasone implant injection for various retinal conditions.MethodsRetrospective multicenter analysis of intravitreal dexamethasone implant injections (700 µg) due to various retinal conditions including central retinal venous occlusion (1861 injections), diabetic macular oedema (3104 injections), post-surgical cystoid macular oedema (305 injections) and uveitis (381 injections). The eyes were evaluated mainly for the occurrence of adverse events such as glaucoma, cataract, retinal detachment and endophthalmitis along during the follow-up period.ResultsA total of 6015 injections in 2736 eyes of 1441 patients (mean age of 65.7±12.9 years) were in total analysed over an average period of 18 months (range 6 months to 102 months). A total of 576 eyes (32.5% of the phakic eyes) developed cataract requiring surgical intervention. However, visually insignificant cataract progression was observed in another 259 phakic eyes (14.6%) which did not require surgical removal. A total of 727 eyes (26.5%) experienced an intraocular pressure (IOP) rise of >25 mm Hg, with 155 eyes (5.67%) having a prior history of glaucoma and 572 eyes (20.9%) having new onset IOP rise. Overall, more than 90% of eyes with IOP rise were managed medically, and 0.5% eyes required filtering surgery. Endophthalmitis (0.07%), retinal detachment (0.03%) and vitreous haemorrhage (0.03%) were rare. There was no significant change in visual acuity (p=0.87) and central macular thickness (p=0.12) at the last follow-up.ConclusionThis is the largest real-life study assessing the safety of intravitreal dexamethasone implant injections in various retinal conditions. Cataract progression and intraocular pressure rise are the most common side effects, but are often rather easily manageable.
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- 2019
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36. Intraocular pressure (IOP) after intravitreal dexamethasone implant (Ozurdex) amongst different geographic populations—GEODEX-IOP study
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Nidhee Jain, Dinah Zur, Matias Iglicki, Fernando Miassi, Hyeong Gon Yu, Anat Loewenstein, Sean Tsao, Ashish Sharma, Alan Kardec Barreira, V R Saravanan, Leandro Cabral Zacharias, Sung Wook Park, Deepika Makam, Daniele Veritti, Baruch D. Kuppermann, Francesco Bandello, Paolo Lanzetta, Sharma, A., Kuppermann, B. D., Bandello, F., Lanzetta, P., Zur, D., Park, S. W., Yu, H. G., Saravanan, V. R., Zacharias, L. C., Barreira, A. K., Iglicki, M., Miassi, F., Veritti, D., Tsao, S., Makam, D., Jain, N., and Loewenstein, A.
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medicine.medical_specialty ,Intraocular pressure ,genetic structures ,Diabetic macular edema ,India ,Ocular hypertension ,Dexamethasone ,Macular Edema ,Article ,03 medical and health sciences ,0302 clinical medicine ,Ophthalmology ,Retinal Vein Occlusion ,medicine ,Humans ,Israel ,Glucocorticoids ,Intraocular Pressure ,Retrospective Studies ,Drug Implants ,Diabetic Retinopathy ,business.industry ,Incidence (epidemiology) ,medicine.disease ,eye diseases ,White population ,Intravitreal Injections ,030221 ophthalmology & optometry ,Implant ,business ,Tomography, Optical Coherence ,030217 neurology & neurosurgery ,Uveitis ,medicine.drug - Abstract
Purpose: To analyse the intraocular pressure rise after intravitreal dexamethasone implant (Ozurdex) amongst different geographic populations. Methods: The medical charts of 294 dexamethasone implants between February 2011 and 2017 were reviewed retrospectively. South Asian (India), White (Europe, US and Israel) Latino (Argentina and Brazil) patient data was included in the study. Ocular hypertension (OHT) was defined as intraocular pressure of >25 mmHg or an increase of at least 10 mmHg from baseline. The main indications for treatment were diabetic macular edema (ME) (65.6%), retinal vein occlusion (26.5%), uveitis (7.8%). Results: Amongst 294 intravitreal implants, ocular hypertension (>25 mmHg) was recorded in 0, 8 and 9.5% in White, Latino, and South Asian groups, respectively. However, IOP > 20 mmHg was recorded in 14%, 28% and 27% in White, Latino, and South Asian groups, respectively. Incidence of very high IOP (>35 mmHg) was lower in all geographical groups. It was 3% in Latino followed by 2% in South Asian group. Conclusion: Latino and South Asian groups have higher IOP rise compared to White population. Most patients with elevated IOP fluctuate between 20–25 mmHg.
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- 2019
37. Experience with the Pascal® photocoagulator: An analysis of over 1200 laser procedures with regard to parameter refinement
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Paolo Lanzetta, Carola Savorgnani, Ilaria Zucchiatti, Saumil Sheth, Francesco Bandello, Daniele Veritti, Sheth, S, Lanzetta, P, Veritti, D, Zucchiatti, I, Savorgnani, C, and Bandello, Francesco
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Time Factors ,Treatment duration ,Grid photocoagulation ,Normal Distribution ,Thermal management of electronic devices and systems ,Panretinal photocoagulation ,Macular Edema ,White People ,law.invention ,Diabetes Complications ,Automation ,Barrage photocoagulation ,law ,pascal® photocoagulation ,laser treatment duration ,Medicine ,Humans ,Laser power scaling ,focal photocoagulation ,laser power ,Retrospective Studies ,Diabetic Retinopathy ,Laser Coagulation ,laser spot size ,business.industry ,Pascal (unit) ,Laser ,Retinal Perforations ,panretinal photocoagulation ,Ophthalmology ,Original Article ,Nuclear medicine ,business ,Single session - Abstract
To systematically refine and recommend parameter settings of spot size, power, and treatment duration using the Pascal (R) photocoagulator, a multi-spot, semi-automated, short-duration laser system. Materials and Methods: A retrospective consecutive series with 752 Caucasian eyes and 1242 laser procedures over two years were grouped into, (1) 374 macular focal / grid photocoagulation (FP), (2), 666 panretinal photocoagulation (PRP), and (3) 202 barrage photocoagulation (BP). Parameters for power, duration, spot number, and spot size were recorded for every group. Results: Power parameters for all groups showed a non-gaussian distribution; FP group, median 190 mW, range 100 - 950 mW, and PRP group, median 800 mW, range 100 - 2000 mW. On subgroup comparison, for similar spot size, as treatment duration decreased, the power required increased, albeit in a much lesser proportion than that given by energy = power x time. Most frequently used patterns were single spot (89% of cases) in FP, 5 x 5 box (72%) in PRP, and 2 x 2 box (78%) in BP. Spot diameters as high as approximate to 700 mu m on retina were given in the PRP group. Single session PRP was attempted in six eyes with a median spot count of 3500. Conclusion: Overall, due to the small duration of its pulse, the Pascal (R) photocoagulator tends to use higher powers, although much lower cumulative energies, than those used in a conventional laser. The consequent lesser heat dissipation, especially lateral, can allow one to use relatively larger spot sizes and give more closely spaced burns, without incurring significant side effects.
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- 2011
38. Recommendations for the appropriate management of diabetic macular edema: Light on DME survey and consensus document by an expert panel
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Ugo Menchini, Francesco Bandello, Edoardo Midena, Paolo Lanzetta, Bandello, F., Midena, E., Menchini, U., and Lanzetta, P.
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Vascular Endothelial Growth Factor A ,medicine.medical_specialty ,Anti-VEGF ,Diabetic macular edema ,Diabetic retinopathy ,Intravitreal injection ,Ranibizumab ,Ophthalmology ,Visual acuity ,genetic structures ,medicine.medical_treatment ,Visual Acuity ,030209 endocrinology & metabolism ,Angiogenesis Inhibitors ,Macular Edema ,03 medical and health sciences ,0302 clinical medicine ,Surveys and Questionnaires ,medicine ,Humans ,Fluorescein Angiography ,Tomography ,Macular edema ,Diabetic Retinopathy ,Laser Coagulation ,medicine.diagnostic_test ,business.industry ,Medicine (all) ,General Medicine ,medicine.disease ,Fluorescein angiography ,Intravitreal Injections ,Tomography, Optical Coherence ,eye diseases ,Vascular endothelial growth factor A ,Optical Coherence ,030221 ophthalmology & optometry ,medicine.symptom ,business ,Laser coagulation ,medicine.drug - Abstract
Purpose The Light on DME survey was designed to address several issues concerning the management of diabetic macular edema (DME) with the objective of producing practical recommendations for the appropriate treatment of this condition. Methods The recommendations considered aspects of DME treatment that are controversial and insufficiently supported by the evidence and were based on a consensus reached by an expert panel. Consensus was achieved by means of the Delphi method. Thirty-one Italian retinologists were asked to rate the appropriateness of a comprehensive set of scenarios typically encountered in the management of DME in clinical practice. The results of the appropriateness evaluation were analyzed by the study panel and a second assessment round was conducted for those scenarios on which no consensus was reached. Results Consensus was reached on several relevant aspects of current DME management, namely the initiation and course of treatment with anti-vascular endothelial growth factor (VEGF) therapy, assessment of the outcomes of anti-VEGF therapy based on both functional and morphologic outcomes, combination of anti-VEGF with laser therapy, and management of nonresponders to anti-VEGFs. A few issues, including the definition of DME based on novel diagnostic tools, the need for stable metabolic parameters before initiating anti-VEGF therapy, and the use of a second anti-VEFG after failure of the first anti-VEGF, proved controversial. Conclusions A clear consensus among DME experts was reached on several relevant aspects of DME management. Based on this consensus, detailed and practical recommendations to guide ophthalmologists in the use of novel approaches to DME could be developed.
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- 2015
39. Retreatment with Ozurdex for macular edema secondary to retinal vein occlusion
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Albert J. Augustin, Francesco Bandello, Patricia Udaondo, Gabriel Coscas, Marc D. de Smet, Yossi Yatziv, Paolo Lanzetta, Giovanni Staurenghi, Elad Moisseiev, Maria Cristina Parravano, Anat Loewenstein, Gisèle Soubrane, Coscas, G, Augustin, A, Bandello, Francesco, de Smet, Md, Lanzetta, P, Staurenghi, G, Parravano, Mc, Udaondo, P, Moisseiev, E, Soubrane, G, Yatziv, Y, and Loewenstein, A.
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Adult ,Male ,medicine.medical_specialty ,Retinal Vein ,Visual acuity ,genetic structures ,Visual Acuity ,Dexamethasone ,Macular Edema ,Retinal vein occlusion ,Ophthalmology ,Occlusion ,Retinal Vein Occlusion ,Medicine ,Humans ,Dexamethasone implant ,Fluorescein Angiography ,Macular edema ,Glucocorticoids ,Aged ,Retrospective Studies ,Aged, 80 and over ,Drug Implants ,medicine.diagnostic_test ,business.industry ,Retrospective cohort study ,General Medicine ,Middle Aged ,medicine.disease ,Fluorescein angiography ,eye diseases ,Surgery ,Treatment Outcome ,Ozurdex ,Delayed-Action Preparations ,Retreatment ,Female ,medicine.symptom ,Injections, Intraocular ,business ,Complication ,medicine.drug - Abstract
Purpose To review the current practice of retreatment with Ozurdex injections in patients with macular edema (ME) secondary to retinal vein occlusion (RVO), and to recommend simple guidelines for Ozurdex reinjection in management of RVO. Methods This was a multicenter retrospective study of patients who received more than 2 Ozurdex injections for the treatment of ME in RVO. Recorded parameters included percent of patients with a 15-letter gain, visual acuity (VA) improvement from baseline, change in central macular thickness (CMT), time to reinjection, and occurrence of any complications. Results A total of 128 patients were included, 58 (45.3%) with central RVO (CRVO) and 70 (54.7%) with branch RVO (BRVO). Mean interval for Ozurdex reinjection was 5.9 months following the first injection and 8.7 months following the second. A >15-letter gain in VA was observed in 34 (48.8%) patients with CRVO and 16 (28%) patients with BRVO. Mean overall VA improvement at month 6 did not show significance (p>0.05); however, a significantly better mean VA improvement was seen in treatment-naïve eyes (pConclusions Repeated injections of Ozurdex are effective and have a favorable safety profile. In current practice, the retreatment interval with Ozurdex injections might be too long, precluding the full therapeutic potential of this treatment modality. A strategy for managing RVO patients treated with Ozurdex on an as-needed basis is provided.
- Published
- 2013
40. Posterior juxtascleral infusion of modified triamcinolone acetonide formulation for refractory diabetic macular edema: one-year follow-up
- Author
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Paolo Lanzetta, L. Perissin, Francesco Bandello, Daniele Veritti, Veritti, D, Lanzetta, P, Perissin, L, and Bandello, Francesco
- Subjects
Male ,medicine.medical_specialty ,Visual acuity ,Triamcinolone acetonide ,genetic structures ,medicine.drug_class ,Eye disease ,Sodium hyaluronate ,Visual Acuity ,Triamcinolone Acetonide ,Macular Edema ,chemistry.chemical_compound ,Ophthalmology ,medicine ,Humans ,Infusions, Parenteral ,Prospective Studies ,Fluorescein Angiography ,Hyaluronic Acid ,Glucocorticoids ,Aged ,Diabetic Retinopathy ,medicine.diagnostic_test ,business.industry ,Chondroitin Sulfates ,Middle Aged ,medicine.disease ,Fluorescein angiography ,Acetonide ,eye diseases ,Treatment Outcome ,chemistry ,Corticosteroid ,Drug Therapy, Combination ,Female ,sense organs ,medicine.symptom ,business ,Sclera ,Tomography, Optical Coherence ,Retinopathy ,medicine.drug ,Follow-Up Studies - Abstract
PURPOSE. To evaluate prospectively the efficacy and safety of posterior juxtascleral infusion of a new formulation of triamcinolone acetonide for refractory diffuse diabetic macular edema. METHODS. This was an interventional case series. Twenty-two consecutive eyes of 18 patients with refractory diffuse diabetic macular edema were included in the study. Each patient underwent a complete ophthalmic examination, including optical coherence tomography (OCT) and digital fluorescein angiography (FA). All patients received a suspension of 40 mg triamcinolone acetonide, 20 mg sodium chondroitin sulfate, and 15 mg sodium hyaluronate (1.5 mL), delivered posteriorly through a conjunctival and Tenon's incision. All patients completed the 1-year follow-up. RESULTS. On average, studied eyes received 1.5 treatments. Mean preoperative foveal thickness (+/- SD) and visual acuity (+/- SD) were 474.2 +/- 136.6 mu m and 0.6 +/- 0.37 logarithm of the minimum angle of resolution (logMAR), respectively. The central foveal thickness was significantly reduced from baseline at every follow-up visit (P < 0.001). Mean (+/- SD) reductions in macular thickness were 136 +/- 108 mu m at 1 week and 128 +/- 122 mu m after 1 year of follow-up. Mean (+/- SD) improvement in visual acuity at 12 months was 0.15 +/- 0.21 logMAR (P = 0.008). Visual acuity improvement of one or more lines and three or more lines were observed in 14 (63.6%) and 6 (27.3%) eyes, respectively. Seven eyes (31.8%) required topical treatment due to a significant intraocular pressure increase. CONCLUSIONS. Posterior juxtascleral infusion of a new formulation of triamcinolone acetonide is an effective treatment for diffuse diabetic macular edema unresponsive to conventional grid laser photocoagulation. A randomized, larger study is warranted. (Invest Ophthalmol Vis Sci. 2009;50:2391-2397) DOI:10.1167/iovs.08-2518
- Published
- 2009
41. When and how to do a grid laser for diabetic macular edema
- Author
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F, Bandello, P, Lanzetta, U, Menchini, Bandello, Francesco, Lanzetta, P, and Menchini, U.
- Subjects
Diabetic Retinopathy ,Laser Coagulation ,Treatment Outcome ,Blood-Retinal Barrier ,Humans ,Macula Lutea ,Pigment Epithelium of Eye ,Macular Edema - Abstract
Macular edema is a common feature of posterior segment diseases. It is an expression of abnormal permeability in either retinal vessels (inner blood-retinal barrier) or in the retinal pigment epithelium (outer blood-retinal barrier). It occurs in either a diffuse pattern where the macula appears generally thickened or, in more severe cases, as cystoid edema with the typical petaloid appearance. Grid laser treatment may be useful to reduce macular edema. Spots of 100-250 micrometers in diameter are applied to the whole posterior pole, one to two groups apart. The foveal avascular zone remains untouched. In patients treated bilaterally, areas temporal and nasal to the macula must be spared to prevent the development of deep scotomas. The mechanism yielding positive results with the grid technique is still debated. Among the most reliable hypotheses are: Proliferation of pigment epithelial cells, followed by and improved efficiency of the outer blood-retinal barrier; proliferation of endothelial cells in retinal capillaries followed by an improved efficiency of the inner blood-retinal barrier; improvement of the retinochoroidal exchanges, and finally, release by coagulative necrosis of a factor able to improve the efficiency of the blood-retinal barriers. Lasers with long wavelengths, such as krypton red and diode, are the most appropriate ones to perform grid treatment.
- Published
- 1999
42. Efficacy of diclofenac eyedrops in preventing postoperative inflammation and long-term cystoid macular edema
- Author
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C. Monaco, Francesco Ponte, S. Bonini, R. Neushüler, C. Della Loggia, Francesco Carones, Adolfo Sebastiani, Francesco Bandello, S. Bianco, L. Lobefolo, Leonardo Mastropasqua, C. D'Annunzio, Paolo Lanzetta, A. Cillino, M.C. Bucci, Ugo Menchini, Pier Enrico Gallenga, L. Mansutti, G. Lamberti, Daniele Tognetto, Andrea Lovisato, S. Morreale, A. Capocotta, Rosario Brancato, Enzo Ballone, Giuseppe Ravalico, Gallenga, Pe, Mastropasqua, L, Lobefalo, L, Dellaloggia, G, Ballone, E, Dannunzio, G, Brancato, R, Bandello, Francesco, Carones, F, Sebastiani, A, Capocotta, A, Lamberti, G, Ponte, F, Cillino, A, Morreale, S, Neushuler, R, Monaco, C, Bucci, Mg, Bonini, S, Ravalico, G, Tognetto, D, Lovisato, A, Menchini, U, Lanzetta, P, Mansutti, L, and Bianco, S.
- Subjects
medicine.medical_specialty ,medicine.diagnostic_test ,business.industry ,medicine.medical_treatment ,Inflammation ,Diclofenac Sodium ,Cataract surgery ,medicine.disease ,Fluorescein angiography ,Sensory Systems ,Surgery ,Ophthalmology ,Regimen ,Diclofenac ,Anesthesia ,Relative risk ,Medicine ,medicine.symptom ,business ,Macular edema ,medicine.drug - Abstract
Purpose: To compare the efficacy and tolerance of diclofenac 0.1 % eyedrops with a regimen that included a brief course of steroids in the treatment of postoperative inflammation after extracapsular cataract surgery and posterior chamber intraocular lens implantation. A second objective was to compare the efficacy of diclofenac 0.1% eyedrops in the same patients and control group in preventing cystoid macular edema (CME). Setting: Eight university/hospital centers and one company in Italy. Methods: The multicenter, controlled, randomized, prospective, double-blind study included 281 patients. All were evaluated at baseline, at surgery, and after 1, 5, 36, 67, and 140 days. Postoperative inflammation was measured by the clinical assessment of inflammation: conjunctival hyperemia, ciliary flush, Tyndall effect, and cells in the anterior chamber. Fluorescein angiography was performed to evaluate the presence/absence of CME before surgery and after 36 and 140 days. Results: During follow-up, no differences in intraoperative pressure were observed within or between groups or between operated and fellow eyes. No statistically significant between-group differences in postoperative inflammation were found. After 36 days, angiographic CME was found in 9 patients (6.43%) in the diclofenac group and 20 (15.15%) in the control group (P = .033) with a relative risk for developing CME of 0.40 (Cl95 0.19 to 0.84). At the end of follow-up, it was found in 4 patients in the diclofenac group (3.31%) and 10 (9.26%) in the control group (P = .05) with a relative risk of 0.36 (Cl95 0.12 to 0.90). Conclusion: Diclofenac sodium was as effective as the control regimen in controlling postoperative inflammation after cataract surgery. It also had a protective effect on the development of angiographic CME after 36 and 140 days.
- Published
- 1997
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