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Describe drug utilisation and clinical outcomes of intravitreal anti-VEGF drug and dexamethasone use in the real-world setting in Southern Italy using data from multi-centre study of retinal disease. Clinical data of retinal disease patients treated with anti-VEGF drugs and dexamethasone implant in 6 out-patient ophthalmology centres from Southern Italy were collected by means of an electronic case report form. Patients receiving at least one intravitreal injection/implant of the study drugs were followed for up to two years and described in terms of demographics and clinical characteristics. Drug utilisation patterns were described. A sign-rank test was used to compare clinical data on visual acuity and other ophthalmic parameters from baseline at different follow-up times for each indication. Data from 1327 patients was collected. Most patients were diagnosed with age-related macular degeneration (AMD) (660, 49.7%), followed by diabetic macular oedema (423, 31.9%), retinal vein occlusion (164, 12.3%), and myopic choroidal neovascularization (80, 6.0%). Patients were followed for a median of 10.3 months (interquartile range: 3.6 – 24.7 months). Mean patient age was 69.7 (±10.9) years and 54.2% were males. Ranibizumab (55.4%) and aflibercept (27.5%) were the most commonly used drugs. Baseline visual acuity significantly improved by about 0.05 to 0.1 logMAR at all follow-up times for AMD and RVO but less consistently for the other diseases. Intravitreal ranibizumab use accounted for half of all treatment for retinal diseases in a Southern Italian out-patient setting. Patients treated with anti-VEGF drugs for AMD and RVO in Southern Italy experienced significant improvement in VA.

Purpose To evaluate whether outcome of bevacizumab treatment in the first treated eye can guide the selection of compound for the second treated eye in patients with bilateral diabetic macular edema. Methods Demographic, clinical, and optical coherence tomography data were retrospectively collected from consecutive patients who underwent bevacizumab therapy for bilateral diabetic macular edema. Change in central subfield thickness and visual acuity were evaluated and compared between the first treated eye and second treated eye. Results A total of 66 eyes of 33 patients were included in the study. The mean ± SD follow-up time was 13 ± 5 months. The mean ± SD central subfield thickness at baseline was 464 ± 30 μm in the first treated eye and 461 ± 29 μm in the second treated eye ( p = 0.91). Final central subfield thickness was reduced to 392 ± 27 μm in the first treated eye ( p = 0.01 compared with baseline) and 416 ± 25 μm in the second treated eye ( p = 0.03 compared with baseline). Using ≥5% or ≥10% reduction of central subfield thickness as diagnostic criteria to predict similar magnitude of thickness reduction in the first treated eye yielded a positive and negative predictive value ranging from 46% to 81%, and sensitivity and specificity ranging from 54% to 84%. Regression models did not show correlation between central subfield thickness reduction in first treated eye and the second treated eye at the end of follow-up. Conclusions Bevacizumab therapy reduced macular thickness in both eyes in bilateral diabetic macular edema. Treatment outcome of the first treated eye could not predict the outcome of the second treated eye. Particularly, failure to reduce central subfield thickness in the first treated eye does not preclude a favorable response to bevacizumab therapy in the second eye.

Purpose To evaluate the microvascular changes in the macular and peripapillary area after intravitreal dexamethasone implant in diabetic macular edema (DME) Material and Methods We included 31 eyes of 31 patients treated with a single dose dexamethasone implant for DME. All subjects underwent swept-source optical coherence tomography (OCT) and OCT angiography imaging before (T0), and one month (T1), two months (T2), and four months (T4) after dexamethasone injection. The foveal avascular zone (FAZ) area of superficial and deep capillary plexus (SCP and DCP) was calculated by delineating the FAZ border using the measurement tool of the device. The vessel density (VD) of SCP and DCP and choriocapillaris (CC) in the macular and peripapillary area were automatically calculated. Results There was an insignificant reduction in FAZ area measurements of SCP after dexamethasone injection in DME patients (p = 0.846). The FAZ area of DCP were significantly smaller compared to T0 measurements at T1, T2, and T4 (p = 0.013, p = 0.031, and p = 0.029, respectively). The mean average parafoveal VD measurements were significantly decreased after dexamethasone injection in SCP and DCP (p = 0.004, p = 0.005). The peripapillary VD in retinal capillary plexuses and choriocapillaris showed no significant difference after dexamethasone injection. Conclusion Intravitreal dexamethasone leads to a significant FAZ area decrease in DCP with a reduction in parafoveal VD measurements. In addition, no significant VD changes were observed in the peripapillary area after dexamethasone. These findings indicate that dexamethasone may improve macular ischemia with no significant effects on peripapillary microvasculature in DME patients.

Purpose: To compare the efficacy of intravitreal (IV) ranibizumab (IVR) injection with IV dexamethasone implant (IVDEX) in treatment naive diabetic macular edema (DME) patients with inflammatory component. Materials and methods: Treatment naive DME eyes with subfoveal neurosensorial detachment (SND) and hyperreflective spots (HRS) were treated either three loading doses of IVR (18 eyes) or one dose of IVDEX (19 eyes). Central macular thickness (CMT), height of SND, the number of HRSs scattered on the individual retinal layers and photoreceptor integrity were assessed using spectral domain- optical coherence tomography scans over 3-months follow-up. Results: The mean change in best-corrected visual acuity (BCVA) was −0.11 ± 0.08 logMAR in IVDEX group and −0.04 ± 0.06 logMAR in IVR group at 1-month ( p = 0.011). IVDEX group showed statistically significant more increase in BCVA compared to those receiving IVR injections at 2-months ( p = 0.004) and 3-months ( p = 0.017) visits. Compared to baseline, the number of total HRSs and the number of HRSs at each individual inner retinal layer significantly decreased in both groups at all follow-up visits. However, IVDEX group showed more decrease in the total number of HRSs at 2- and 3-months ( p Conclusion: HRSs tended to migrate from inner retina to the outer retina in DME eyes by treatment. Dexamethasone seemed to be more effective option in such cases with inflammatory component.

Purpose To provide consensus on the clinical use of intravitreal dexamethasone (DEX) implant for the treatment of diabetic macular edema (DME) in Turkey. Methods A panel of 22 retina experts prepared 77 statements of recommendation, and 80 retinal specialists practicing in Turkey were chosen to vote either in support or against each one. A Delphi-based method was used through which the ophthalmologists were able to view all of the results anonymously after two rounds and modify their subsequent answers. The survey was conducted via a mini website, and statements without consensus were resent to the specialists with the latest vote results a week later. Results A total of 72 ophthalmologists answered the first and second round questions. After the first stage, consensus was achieved on 55 of the statements, leaving 22 without agreement. After the second stage, consensus was reached on 11 of the remaining statements. Strong consensus was achieved on statements regarding the etiopathogenesis of DME and the first-line indications and safety of the DEX implant procedure. The panel recommended the use of DEX implant for patients with an arterial thromboembolic event in the last three months and also agreed that pro re nata DEX implant treatment not only provides better outcomes for DME patients but also reduces the treatment burden for those who could not receive an adequate number of anti-vascular endothelial growth factor (VEGF) injections. Conclusion This study provides clinical consensus and recommendations about the use of DEX implant in the clinical practice of DME management in Turkey.

Purpose: Evaluate the efficacy and safety of intravitreal 0.19 mg fluocinolone acetonide (FAc) micro implant in patients with chronic diabetic macular edema (cDME). Methods: Prospective study recruiting subjects with cDME. Inclusion criteria: cDME for at least 2 years documented with OCT imaging; pseudophakia; previous treatments with laser photocoagulation and intravitreal injections of anti-VEGF and/or dexamethasone. Exclusion criteria: phakia; ocular hypertension; tractional component visible on OCT; glaucoma; previous vitrectomy. Outcome measures included best-corrected visual acuity (BVCA), intraocular pressure (IOP), and central macular thickness (CMT), measured 1, 3, 6, and 12 months post-injection. Data were compared with the Friedman test and significance was set at p Results: A total of 18 eyes with a median duration of cDME of 45 months (25–118 months). The 77% of subjects either maintained or improved their BVCA. About 17% and 33% of subjects showed an improvement of 15 ETDRS letters or more at 3 and 12 months respectively. The 17% and 28% of subjects showed a CMT Conclusion: The FAc micro implant has proved efficacy in improving and/or maintaining BVCA in 77% of patients with cDME up to 12 months post-injection. Ocular hypertension is the most common side effect but responds well to topical therapy.

Purpose: To determine the prognostic characteristics of optical coherence tomography (OCT) parameters by evaluating diabetic macular edema (DME) patients with early dexamethasone (DEX) shift after three doses of intravitreal ranibizumab (RNB) injection. Methods: Fifty-four eyes of 34 patients who had DEX implant after three doses of RNB were included in this retrospective study. Early DEX shift includes patients who received direct DEX implant replacement after three doses of RNB load. Baseline OCT values and factors affecting best corrected visual acuity (BCVA) and central macular thickness (CMT) response were analyzed with logistic regression analyses. Results: The presence of subretinal fluid and hyperreflective spot (HRS) >20 were found to be a negative predictive factor for anatomical response. ( p = 0.009, p = 0.001, respectively) Low initial BCVA creates a positive effect on visual gain.( p = 0.041) Giant outer nuclear layer cysts, completely disrupted inner segment-outer segment and HRS > 20 have a negative effect on visual gain. ( p = 0.025, p = 0.043, p = 0.023, respectively) According to the receiver operating characteristic analysis, the subretinal fluid volume threshold at which >20% reduction in CMT occurs was determined to be 0.85 mm3. (sensitivity 70%, specificity 84% area under the curve 0.817, p = 0.021). Conclusion: The presence of high number of HRS and high subretinal fluid volume at the baseline negatively affect prognosis even in patient groups with early DEX shift.

Background: There is a lack of consensus on the use of intravitreal corticosteroid therapies in patients with diabetic macular edema (DME) and prior vitrectomized eyes in clinical practice. Methods: Retro-IDEAL was a 3-year retrospective, multicenter study in patients with chronic DME (i.e. DME that persists or recurs despite treatment) treated with ILUVIEN® (0.2 µg daily fluocinolone acetonide intravitreal implant), who had suboptimal outcomes with first-line vascular endothelial growth-factor inhibitors and other DME therapies. Results: A total of 81 eyes (63 patients) were included of which 39 eyes had undergone prior vitrectomy (PV group) while 42 eyes had not undergone prior vitrectomy (NPV). Baseline characteristics were balanced; however, more patients had proliferative diabetic retinopathy in the PV group vs. the NPV group (21.62% vs 9.38%, respectively). Over 36 months, mean visual acuity (VA) increased in both groups with a tendency for more ETDRS letters being gained in the NPV group (+5.33) vs. the PV group (+2.42). By month 36, central retinal thickness was reduced to ⩽300 µm in two-thirds of the eyes in both groups and the mean change from baseline in intraocular pressure was similar in both groups (+0.50 mmHg −0.75 mmHg; NPV and PV group). Conclusions: These long-term data suggest that the 0.2 μg/day FAc implant is effective in both vitrectomized and non-vitrectomized patients, with a manageable safety profile, and improved VA and reduced supplemental therapies for patients with a suboptimal response to first-line DME therapies. Clinicians may consider utilizing the FAc implant earlier in the DME disease process.

Purpose: To assess the feasibility and clinical effectiveness of dexamethasone intravitreal implant 0.7 mg (IDI) administered in diabetic patients to prevent the worsening of macular edema. Methods: Forty eyes of 40 consecutive patients with naïve macular edema secondary to diabetes mellitus who were treated with IDI administered preoperative (Group A: 20 patients) or IDI administered immediately after cataract surgery (Group B: 20 patients). Best-corrected visual acuity (BCVA) and central macular thickness (CMT) changes were evaluated at baseline and at postoperative time points. Results: Follow-up study was 20 weeks. In Group A and B, mean BCVA improved significantly at all post-surgery time points ( p Conclusions: The use of intravitreal dexamethasone implant 1 month prior to scheduled cataract extraction or at the time of phacoemulsification appears to be safe and effective for at least 16 weeks after surgery.

Purpose: To assess patient satisfaction regarding the sudden reorganization of care during the COVID-19 pandemic in the outpatient intravitreal injection (IVI) clinic. Methods: A survey of patients with ongoing IVIs for retinal diseases was carried out between April 23rd and May 12th, 2020. We designed a questionnaire to assess patient satisfaction concerning: personal protective equipment (PPE), social distancing, the perceived quality of care, and the total time spent in the department, using a Likert scale. We also collected the time spent per patients in the outpatient IVI clinic. Results: A hundred and twenty-seven eyes of 108 patients were included. The mean time spent in the IVI outpatient clinic was 31.87 +/− 16.61 min. In our survey, 99.1% of the patients were satisfied (highly satisfied or satisfied) with the new type of care provided, 89.8% with the duration of care, and 93.5% with the PPE. Satisfaction was associated with total time spent in hospital ( p = 0.005), with dissatisfied patients spending about 50% more time in the hospital than satisfied patients (43.91 min vs 30.50 min). Conclusion: Despite the crisis-related adjustment, our survey revealed high patient satisfaction with PPE, quality of care, and total time spent in outpatient IVI clinic.

Purpose: To determine the levels of serum oxidative, antioxidative markers and inflammatory cytokines in patients diagnosed with diabetic macular edema (DME) whose hyperreflective spots (HRS) were detected by optical coherence tomography (OCT). Methods: In this prospective cross-sectional clinical study included a total of 88 patients; 31 patients (group-1) with DME and HRS detected by OCT, 29 patients (group-2) with DME without HRS, and 28 patients (group-3) diagnosed with diabetes mellitus (DM) without any diabetic retinopathy findings. The main outcomes were best-corrected visual acuity (BCVA), CMT (central macular thickness), CMV (central macular volume), TMV (total macular volume), CT (choroidal thickness), serum TAS (total antioxidant status), TOS (total oxidant status), VEGF (vascular endothelial growth factor), FGF (fibroblast growth factor) and IL-1b levels. OCT parameters and biochemical measurements were compared statistically between the three groups. Results: A total of 88 patients (43 females (48.9%) and 45 males (51.1%)) were included in the study. The mean age was 56.29 ± 9.23 years. There was no difference between the three groups in age-and-sex. In group-1 and 2, BCVA(LogMAR) was statistically higher than group 3. CMT, CMV, TMV, TAS, TOS, VEGF and FGF were significantly higher in group-1 than in group-3. CMT, CMV, TMV, VEGF and FGF were significantly higher in group-2 than group 3. TOS and VEGF were significantly higher in group-1 than group-2. Conclusions: This study demonstrates that in patients with DME and HRS, TOS and VEGF levels were higher than those without HRS. Hence, hyperreflective spots may be an inflammatory biomarker.

Purpose: To investigate aqueous humor (AH) and serum levels of brain-derived neurotrophic factor (BDNF) in non-proliferative diabetic retinopathy (NPDR) patients with diabetic macular edema (DME). Methods: The prospective study consists of 20 patients with DME NPDR, 20 patients with no-DME NPDR, and 20 healthy control subjects. Serum and AH samples were obtained during cataract surgery and intravitreal injection. Serum and AH levels of BDNF were measured by enzyme-linked immunosorbent assay. Results: The mean serum levels of BDNF were lower in both NPDR groups compared to the control group (DME NPDR group, p = 0.015; no-DME NPDR group, p = 0.024). Furthermore, the mean serum level of BDNF was lower in the DME NPDR group compared to the no-DME NPDR group ( p = 0.041). The mean AH levels of BDNF were significantly reduced in both NPDR groups compared to the control group (DME NPDR group, p Conclusion: Serum and AH levels of BDNF were reduced in NPDR patients with DME than without DME.

Purpose: Intravitreal corticosteroid implants based on sustained-release dexamethasone provide effective retinal delivery of drug for around 6 months for the treatment of diabetic macular edema (DME). As current recommendations on the management of patients with DME undergoing cataract surgery are limited, this article aims to highlight issues and provide guidance on the use of dexamethasone intravitreal implants (DEX-DDS) in patients with DME undergoing cataract surgery, based on the consensus findings of a panel of Italian experts. Methods: The panel developed a survey regarding the use of DEX-DDS in patients with DME undergoing cataract surgery, following a comprehensive literature search. The results of the survey were discussed at an experts’ meeting in September 2018, with a structured approach to determining consensus. The routine management of patients with DME undergoing cataract surgery was also developed for use as a basis of discussion to highlight current issues. Results: Eight consensus statements are presented, along with key issues that highlight controversial/outstanding issues in the use of DEX-DDS in DME patients with cataracts. Conclusion: The consensus statements can help provide practical guidance for clinicians in daily practice on the rationale, patient diagnosis and selection, and optimal management of patients with DME undergoing cataract surgery.

Purpose: The purpose of this study was to determine the effects of dexamethasone implant (0.7 mg) on biomarkers such as hyper-reflective dots, external limiting membrane integrity and disorganization of retinal inner layers in treatment-naïve patients, patients who received less than three anti-vascular endothelial growth factor injections and non-responder cases with diabetic macular edema and its effects on edema and visual acuity. Methods: This is a prospective study of treatment-naïve patients, patients who received less than three anti-vascular endothelial growth factor injections and non-responder patients with diabetic macular edema, treated with single dexamethasone implant. Pre- and post-injection-based best-corrected visual acuity, central macular thickness, hyper-reflective dots, external limiting membrane integrity and disorganization of retinal inner layers were assessed. Results: A total of 27 diabetic macular edema eyes, including 9 non-responder eyes, 9 eyes which received less than three anti-vascular endothelial growth factor injections and 9 treatment-naïve eyes, were included in this study. Baseline hyper-reflective dots were 22.22 ± 11.76, 30 ± 7.91 and 19.44 ± 8.82 which reduced to 3.33 ± 1.32, 9 ± 8.35 and 8.78 ± 2.53 four months after implant in treatment-naïve patients, patients who received less than three anti-vascular endothelial growth factor injections and non-responder cases, respectively. Baseline central macular thickness was 589.44 ± 175.37, 537 ± 181.81 and 673.11 ± 138.24 and the central macular thickness after dexamethasone implant was 272.11 ± 39.00, 336.44 ± 132.88 and 524.00 ± 200.39 in treatment-naïve patients, patients who received less than three anti-vascular endothelial growth factor injections and non-responder cases, respectively. External limiting membrane integrity was restored in two patients in each group, whereas two patients with disorganization of retinal inner layers in treatment-naïve group showed reorganization of retinal structures after treatment with dexamethasone implant. Conclusion: Better response to dexamethasone implant in cases with more hyper-reflective dots shows that these hyper-reflective dots can be used as a predictive biomarker. Dexamethasone implant might help in restoring external limiting membrane integrity and resolution of disorganization of retinal inner layers.

Purpose: The purpose was to compare the incidence of endophthalmitis after intravitreal injection with and without topical antibiotic prophylaxis. Methods: This is a single-center, retrospective case–control study. All patients treated with intravitreal injection of ranibizumab, bevacizumab, aflibercept, or corticosteroids for a variety of retinal vascular diseases between 1 October 2014 and 30 November 2018 were included. The total number of patients and injections were determined from a review of billing code and practice management records. Endophthalmitis cases were determined from billing records and then confirmed with chart review. A 24-month period when topical antibiotics were prescribed after intravitreal injection was compared with a 24-month period when topical antibiotics were not prescribed. Results: Between 1 October 2014 and 30 November 2018, a total of 33,515 intravitreal injections were performed and 13 cases of post–intravitreal injection endophthalmitis were identified (incidence rate of 0.0388%; 95% confidence interval, 0.0217%–0.0644%) or approximately 1 case for every 2578 intravitreal injections. Between 1 October 2014 and 31 October 2016, while topical antibiotic prophylaxis was used postoperatively, 14,828 intravitreal injections were performed and 5 cases of endophthalmitis were reported (0.0337%; 95% confidence interval, 0.0129%–0.0739%). Between 1 November 2016 and 30 November 2018, while no prophylaxis was used, 18,687 intravitreal injections were performed and 8 cases of endophthalmitis were identified (0.0428%; 95% confidence interval, 0.0202%–0.0808%). There were no statistical differences in the incidence rates between the two groups ( p = 0.675). Conclusion: The incidence rate of endophthalmitis in the group with topical antibiotic prophylaxis after intravitreal injection was similar to the group with no prophylaxis. Changing the current clinical practice to no antibiotic prophylaxis had no effect on the incidence of endophthalmitis.

Purpose: The purpose was to evaluate the change in the microbiological profile of diabetic patients undergoing intravitreal injections for diabetic macular edema. Methods: Patients were included in this prospective study when referred for the first time for intravitreal injection to treat diabetic macular edema. For each patient, conjunctival cultures were taken from the lower fornix of each eye prior to the povidone-iodine application and the intravitreal injection. An additional culture was taken from the treated eye 20 min after the injection. The same culture protocol was used for the two following injections of these patients. A later conjunctival culture was also taken a month after the last injection. Results: Twenty-one eyes of 21 patients were included. The mean duration of diabetes was 13.7 ± 7.9 years. Prior to the first intravitreal injection, 33% of cultures were positive. Prior to the third intravitreal injection, 26% of cultures were positive ( p = 0.63), and 1 month after the last injection, 18% of cultures were positive ( p = 0.495). The mean HbA1C was 8.1% ± 1.7%. HbA1C of patients with positive cultures was 8.0% ± 1.1% at the first intravitreal injection and 8.2% ± 1.0% at the third intravitreal injection. This was compared with HBA1C in eyes with negative cultures: 7.4% ± 1.2% ( p = 0.45) and 7.1% ± 1.0% ( p = 0.14), respectively. Conclusion: Repeated intravitreal injection for diabetic macular edema with application of povidone-iodine 5% in diabetic patients did not lead to a significant change in the percentage of positive conjunctival cultures. Patients with higher HbA1C had a slight, non-statistically significant trend for positive cultures.

Purpose: We sought to evaluate whether additional topical anesthetic, specifically proparacaine 0.5%, improved patient experience with intravitreal injections without hindering antisepsis. Methods: A prospective, randomized controlled trial was conducted including 36 eyes of 36 patients undergoing intravitreal injections. Patients were randomized to treatment with additional topical proparacaine 0.5% versus control after undergoing informed consent. All patients prior to intravitreal injection underwent conjunctival culture after one drop of topical proparacaine 0.5% was placed. Half of patients then received an additional drop of proparacaine and then underwent a second conjunctival culture. The other half of patients had a drop of povidone iodine and then a second conjunctival culture. Intravitreal injection followed conjunctival cultures. To evaluate their experience, patients were provided with a survey. Results: In total, 36 patients were enrolled in the study. Three of 36 (8.3%) patients had positive conjunctival cultures after proparacaine eye drops alone. One of 17 (5.8%) patients had a positive conjunctival culture after a second drop of proparacaine. One of 19 (5.3%) patients had a positive culture after proparacaine and povidone iodine. By noninferiority analysis, proparacaine was inferior to povidone iodine ( p = .28). Patient experience surveys did not differ between groups. Conclusion: Patient perception did not significantly differ whether or not additional proparacaine drops were used prior to intravitreal injection in a randomized controlled trial. While proparacaine has some antiseptic properties, these were found to be inferior to those of povidone iodine. Therefore, while povidone iodine is essential for antisepsis, additional proparacaine drops should not interfere with antisepsis.

Purpose To investigate the adjunct efficacy and safety of vitamin supplements, including resveratrol, in patients with diabetic macular edema (DME) treated with intravitreal anti-vascular endothelial factor (anti-VEGF) agents. Methods Participants in this prospective study were 45 patients with DME, who were treated with either intravitreal anti-VEGF injections (n = 23, Group I) or with combination of intravitreal anti-VEGF injections and vitamin supplements, including resveratrol (n = 22, Group II). All patients underwent visual acuity measurement, slit-lamp examination and spectral domain-optical coherence tomography (SD-OCT) at baseline and monthly after the loading phase of three-monthly anti-VEGF injections, following a PRN protocol. Results There was a statistically significant improvement in visual acuity in both groups at month 12 compared to baseline, although the mean change in visual acuity did not differ between the two groups (p = 0.183). Accordingly, there was a statistically significant decrease in central retinal thickness in both groups at month 12 compared to baseline, while the mean difference in central retinal thickness was significantly greater in the “combination” group. The mean number of intravitreal anti-VEGF injection was less in Group II (6.45 ± 1.12 in Group II vs. 7.39 ± 1.31 in Group I, p = 0.018). Conclusions Vitamin supplements with resveratrol was found to be an effective adjunct to intravitreal anti-VEGF injections in patients with DME, offering better anatomic restoration with less injections at the 12-month follow-up.

Purpose: INVICOST, a medico-economic analysis, compared costs of managing treatment-naive patients with diabetic macular edema (DME) receiving intravitreal injections (IVIs) of aflibercept (AFL), dexamethasone implant (DXI) or ranibizumab (RAN) over 1 year. Methods: Healthcare resource use and associated costs were estimated using individual patient data from INVICTUS, a prospective, open-label, monocentric study. Healthcare costs comprised direct medical costs such as drug acquisition and administration, consultations and ophthalmological procedures. Costs were assessed from the French National Health Insurance perspective using published national tariffs expressed in 2019 euros. Results: Of the 60 treated eyes, 48 had no treatment switch; 14 received AFL, 19 received DXI and 15 received RAN. AFL-treated eyes received an average of 6.5 IVIs, DXI-treated patients received 2 IVIs and RAN-treated received 6.8 IVIs. All treated eyes received an initial prescription for adjunctive ocular medications and 349 follow-up procedures were performed including an average of 3.9 optical coherence tomography and 3.2 retinography procedures per eye. Average total direct cost of per-eye treatment was €4516 (€1128–€8257). Average cost was €5782 for eyes treated with AFL, €2779 with DXI and €5536 with RAN. Drug therapy was the cost driver: €4394 (76%) for AFL, €1915 for DXI (69%) and €4268 (77%) for RAN. Conclusion: The difference in total treatment cost is largely explained by the significantly lower frequency of IVI and annual cost of therapy with DXI, compared with AFL and RAN. INVICOST is the first study comparing treatment costs with AFL, DXI and RAN in France in current clinical practice.

Purpose: To examine changes of the choroidal morphology in patients with diabetic macular edema (DME) before and after local treatments. Methods: This study was on 20 eyes with DME, observed for more than 24 months. All patients underwent laser photocoagulation (Laser), sub-tenon triamcinolone acetonide injection (TA), or intravitreal aflibercept injection (IVA). Central macular and choroidal thicknesses (CMT/CCT), and choroidal vascular structures consisting of the total choroidal area (TCA), luminal area (LA), and stromal area (SA) were measured by a binarization method. The ratios of LA in TCA were eventually determined as the L/C ratio in each case. Results: The L/C ratio significantly decreased for 24 months in patients with DME ( p = 0.01), whereas no significant differences were noted in other parameters including TCA, LA, SA, or CCT. Among patients treated with Laser ± TA ± IVA, a significant correlation was found between a high L/C ratio at pretreatment and a lower cumulative number of injections (1–2 times/24 months) ( p = 0.04). The L/C ratio in pretreatment showed a significantly inverse correlation with CMT (−0.60, p = 0.02) and subsequent BCVA (logMAR) (−0.59, p = 0.03). Conclusion: This study highlighted that the L/C ratio in pretreatment might predict a change of the visual acuity in DME.

The external limiting membrane (ELM) and ellipsoid zone (EZ) can be observed exquisitely by SD-OCT. In diabetic macular edema (DME), dysfunction of mitochondria, represented by the EZ in the foveal photoreceptors results in reduced visual acuity (VA). An increase in VEGF was found to correlate with increased severity of DR, increased central subfield thickness (CST), and sequential disruption of ELM and EZ. The mechanism of ELM and EZ restoration after anti-VEGF therapy in DME has been discovered. The ELM restores first followed by EZ restoration. Thus, authors have discovered and established ELM as a novel retinal structural barrier.

Purpose: To assess the efficacy and safety of dexamethasone 0.7 mg implants (DEX-I) in patients with diabetic macular edema (DME) either naïve to therapy or refractory to anti-VEGF treatment, in a single-center, real-world setting. Methods: Patients diagnosed with DME and treated with DEX-I were retrospectively enrolled in the study and split in two groups: naïve (Group 1, n = 64) and refractory (Group 2, n = 64) to treatment. Patients were evaluated at baseline, at 1 month, and every 3 months after each DEX-I implant. Main outcome measures were change in best-corrected visual acuity (BCVA) and central macular thickness (CMT) from baseline to follow-up visits. Results: Significant improvements in BCVA were observed in treatment-naïve patients at 6 months following the first and second DEX-I injection ( p = 0.0023 and p = 0.0063, respectively), with significant reductions in mean CMT at 6 months after all DEX implants. In treatment-refractory patients, mean CMT was significantly reduced from baseline to 6 months ( p Conclusions: DEX-I improved visual acuity and macular edema mostly in treatment-naïve patients, suggesting DEX-I may be a viable first-line treatment option in DME.

Purpose: To study the real-life outcomes of intravitreal anti–vascular endothelial growth factor treatment in patients affected by age-related macular degeneration and diabetic macular edema in an Italian tertiary referral hospital over a 2-year follow-up. Methods: Patients with confirmed diagnosis of age-related macular degeneration or diabetic macular edema and 2 years of follow-up were retrospectively analyzed. They underwent a loading dose of three monthly anti–vascular endothelial growth factor injections, with re-treatment performed following a “pro-re-nata” regimen. Best-corrected visual acuity and central retinal thickness were collected and statistically analyzed. Results: In total, 167 diabetic macular edema eyes and 108 age-related macular degeneration eyes were included. Mean age was 63.4 ± 11.8 years for diabetic macular edema and 75.6 ± 8.4 years for age-related macular degeneration. For diabetic macular edema patients, mean number of injections was 5.0 ± 1.7 at 1 year and 2.8 ± 1.8 at 2 years. Mean best-corrected visual acuity improved from 60 Early Treatment for Diabetic Retinopathy Study letters to 66.7 letters at 1 year, and to 70 letters at 2 years (p Conclusions: Our study described the 2-year real-life outcome of anti–vascular endothelial growth factor treatment of diabetic macular edema and age-related macular degeneration.

Purpose: Differentiating the underlying pathology of macular edema in patients with diabetic retinopathy following cataract surgery can be challenging. In 2015, Munk and colleagues trained and tested a machine learning classifier which uses optical coherence tomography variables in order to distinguish the underlying pathology of macular edema between diabetic macular edema and pseudophakic cystoid macular edema. It was able to accurately diagnose the underlying pathology in 90%–96% of cases. However, actually using the trained classifier required dedicated software and advanced technical skills which hindered its accessibility to most clinicians. Our aim was to package the classifier in an easy to use web-tool and validate the web-tool using a new cohort of patients. Methods: We packaged the classifier in a web-tool intended for use on a personal computer or mobile phone. We first ensured that the results from the web-tool coincide exactly with the results from the original algorithm and then proceeded to test it using data of 14 patients. Results: The etiology was accurately predicted in 12 out of 14 cases (86%). The cases with diabetic macular edema were accurately diagnosed in 7 out of 7 cases. Of the pseudophakic cystoid macular edema cases, 5 out of 6 were correctly interpreted and 1 case with a mixed etiology was interpreted as pseudophakic cystoid macular edema. Variable input was reported to be easy and took on average 7 ± 3 min. Conclusion: The web-tool implementation of the classifier seems to be a valuable tool to support research into this field.

Introduction: The Retro-IDEAL (ILUVIEN Implant for chronic DiabEtic MAcuLar edema) study is a retrospective study designed to assess real-world outcomes achieved with the ILUVIEN® (0.19 mg fluocinolone acetonide (FAc)) in patients with chronic diabetic macular edema (DME) in clinical practices in Germany. Methods: This study was conducted across 16 sites in Germany and involved 81 eyes (63 patients) with persistent or recurrent DME and a prior suboptimal response to a first-line intravitreal therapy (primarily anti-VEGF intravitreal therapies). Results: Patients were followed-up for 30.8 ± 11.3 months (mean ± standard deviation) and had a mean age of 68.0 ± 10.4 years. Best-recorded visual acuity (BRVA) improved by +5.5 letters at month 9 (P ⩽ 0.005, n=56; from a baseline of 49 letters) and this was maintained through to month 30 (P ⩽ 0.05, n = 42). There was a concurrent improvement in central macular thickness with a reduction from 502 µm at baseline to 338 µm at year 1 (P ⩽ 0.0001, n = 43). This effect was sustained to year 3 (i.e. 318 µm; P ⩽ 0.0001, n = 29). Mean intraocular pressure (IOP) remained constant between baseline and year 3 with a peak change of 1.9 mm Hg occurring at year 1. Elevated IOP was observed in a similar percentage of patients prior to (22.2% of cases) and following (27.2%) treatment with the FAc implant. In the majority of cases, these elevations were managed effectively with IOP medications. Conclusions: Despite substantial amounts of prior intravitreal treatments – primarily with anti–vascular endothelial growth factor (VEGF) drugs – this real-world study showed that sustained structural and functional improvements can last for up to 3 years with a single FAc implant.

Purpose: To determine whether anemia and other demographic or laboratory “risk factors” impact anti-vascular endothelial growth factor treatment in diabetic macular edema patients. Methods: This is a retrospective, time-varying cohort study using a medical claims database to identify new diabetic macular edema patients who had received at least one intravitreal injection of anti-vascular endothelial growth factor. Exclusion occurred for having Results: In total, 189 new diabetic macular edema patients with follow-up were analyzed, covering 729 visits with 543 (74.5%) receiving treatment. Univariate analysis showed that male gender (odds ratio: 0.54, 95% confidence interval: 0.32–0.91, p = 0.03), every week since last injection (odds ratio: 0.94, 95% confidence interval: 0.91–0.97, p = 0.001), and having two eyes affected (odds ratio: 2.09, 95% confidence interval: 1.10–3.97, p = 0.02) were associated with getting an injection. After multivariate analysis, only time since previous injection with every week that passed reduced the odds on having an injection at the next visit (odds ratio: 0.95, 95% confidence interval: 0.92–0.97, p Conclusion: This study used time-varying methodology to better identify which patients will likely need an injection at any one visit. While anemia was not found to impact injections, our results can aid future endeavors that may incorporate clinical visit information in developing a full prediction model to help make diabetic macular edema care more efficient.

Purpose: To compare the efficacy of ranibizumab and aflibercept in the treatment of diabetic macular edema associated with subfoveal retinal detachment. Methods: This is a retrospective, comparative study. The treatment-naïve diabetic macular edema patients who had diabetic macular edema associated with subfoveal retinal detachment and underwent intravitreal aflibercept or intravitreal ranibizumab treatment were included. The patients were treated on a pro re nata treatment regimen after a loading dose of 3-monthly injections and the follow-up time was 12 months. The primary outcome measure of this study was the presence of subfoveal retinal detachment after treatment at different time points. The secondary outcome measures were the change in best corrected visual acuity and central retinal thickness. Results: A total of 46 eyes of 46 patients were included. The aflibercept group consisted of 20 and the ranibizumab group consisted of 26 eyes. During the follow-up period of 12 months, subfoveal retinal detachment was completely resolved in 75% versus 57.7% of the eyes at month 3 (p = 0.2), 90% versus 76.9% at month 6 (p = 0.2), 90% versus 65.4% at month 9 (p = 0.05), and 100% versus 80.8% at month 12 (p = 0.03) in the intravitreal aflibercept versus intravitreal ranibizumab groups. The change in best corrected visual acuity was not statistically different between the groups at months 3, 6, 9, and 12, respectively (p > 0.05 for all). Conclusion: Both intravitreal aflibercept and intravitreal ranibizumab were effective in regards to anatomical and functional outcomes of diabetic macular edema patients associated with subfoveal retinal detachment. Interestingly, intravitreal aflibercept seemed more effective than intravitreal ranibizumab in the resolution of subfoveal retinal detachment at month 12.

Introduction: The dexamethasone (DEX) implant is an FDA approved treatment for diabetic macular edema, non-infectious posterior uveitis, and macular edema secondary to branch or central retinal vein occlusions. We describe a case of anterior chamber (AC) migration of a DEX implant in a patient with a history of congenital glaucoma and perform a review of the literature on this particular complication, summarizing the common risk factors, subsequent complications, and management options. Case description: A 46-year-old female with a history of congenital glaucoma, status post cataract extraction with insertion of intraocular lens, pars plana vitrectomy, and Baerveldt tube implant in the left eye was referred for post-operative cystoid macular edema (CME). The patient underwent insertion of a DEX implant, resulting in improvement in her CME. After the fourth implant was injected, the patient noticed a white line in her eye while looking in the mirror after doing jumping jacks. Slit lamp examination confirmed migration of the implant into the AC. Ultimately, the patient was taken to the operating room, where her implant was removed via bimanual vitrectomy through an anterior approach. Conclusion: This case report and literature review explores the ophthalmic structural changes specific to congenital glaucoma which may have predisposed this eye to anterior migration of the DEX implant. The purpose of this review is to detail the anatomic changes that may increase the risk of anterior chamber implant migration in patients with congenital glaucoma so that physicians may be aware of these risks when selecting patients for this implant.

Background: Some patients with diabetic macular edema (DME) fail to completely respond to anti-vascular endothelial growth factor (VEGF) therapy. These patients have a high treatment burden in the absence of significant improvement. We investigate the role of intravitreal dexamethasone insert (IDI) in eyes with super-refractory DME. Methods: A non-randomized interventional study was performed among eyes with super-refractory DME refractory to anti-VEGF therapy. Eyes were treated with IDI after failing clinical response to anti-VEGF, with a minimum of 15 prior. Failure to respond was defined as failure of vision to improve at least one line on Snellen Acuity chart, central subfield thickness (CST) greater than 320 μm, or failure of CST to improve by 10% or more. Eyes with glaucoma or prior uncontrolled steroid-responsive ocular hypertension were excluded. Patient outcomes were analyzed at weeks 6, 12, 24, and year 1. Results: Six eyes of four patients were identified. All patients had failed aflibercept. The mean number of prior anti-VEGF injections was 34.5. Eyes received an average of 2.92 dexamethasone injections per person-year (PY) and required breakthrough anti-VEGF injection at 1.95/PY. Mean pre-treatment visual acuity was 0.475 LogMAR, improving to 0.342 at week 6, and 0.375 at 1 year. Mean CST pre-injection was 386.5 mm, improving to 315 mm at 1 year. No glaucoma developed. Conclusions: Intravitreal dexamethasone insert appears effective in eyes with super-refractory DME. IDI resulted in excellent anatomic improvement on SD-OCT as well as modest visual improvement. Injection burden was reduced in those who may otherwise receive years of monthly treatments.

Purpose: To compare effect of topical Nepafenac versus intravitreal Ranibizumab on macular thickness after cataract surgery in diabetic patients with no preoperative macular edema. Patients and methods: A prospective randomized controlled study recruited diabetic patients with visually significant cataract and no diabetic macular edema (DME). Patient underwent uncomplicated phacoemulsification with IOL implantation and were randomly assigned to receive post-operative topical Nepafenac, intra-operative intravitreal Ranibizumab, or no prophylactic treatment. Changes in subfoveal and perifoveal macular thickness were assessed by SD-OCT. Results: The mean central macular thickness showed a significant increase in all study groups 1 week and 1 month postoperative when compared to baseline. At 3 months postoperative, there was a significant difference between Nepafenac and Control group ( p = 0.017), Ranibizumab and Control groups ( p = 0.009) with no significant difference between Nepafenac and Ranibizumab group ( p = 0.545) regarding CMT. Comparable results could be detected as regarding peri-foveal macular thickness changes. Concerning BCVA, there was a significant difference between topical Nepafenac/control ( p = 0.001) and intravitreal Ranibizumab/control ( p = 0.004) at 1-week visit. No significant difference in BCVA was observed between Nepafenac and Ranibizumab group throughout the whole study period. In postoperative visits, cystoid macular edema occurred in three patients (7.9%) in Nepafenac group, one patient (2.7%) in Ranibizumab group, and seven patients (17.07%) in control group. Conclusion: Both postoperative topical Nepafenac and intra-operative intra-vitreal Ranibizumab are effective adjunctive to phacoemulsification in diabetic patients for prophylaxis of macular edema.

Introduction: To evaluate 12-month outcomes following fluocinolone acetonide (FAc 0.2 μg/day) implant in pseudophakic patients with diabetic macular edema (DME) that persists or recurs despite previous treatment with anti-vascular endothelial growth factors (anti-VEGF) and dexamethasone implant (DEX) in a UAE population. Methods: A retrospective, observational, single-center, 12-month audit study, where 22 pseudophakic eyes (22 patients) with DME were treated with the FAc intravitreal implant according to licensed UAE indications. Outcome measurements at baseline and at months 1, 3, 6, and 12 included best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP). Results: Post-FAc implantation, mean BCVA significantly improved at 1, 3, and 12 months (+10.4 ± 16.1, +22.8 ± 13.6, and +25.5 ± 13.0 letters, respectively; p Conclusion: In pseudophakic patients with DME FAc implant provide a substantial functional and anatomical benefits for up to 12 months.

We report our experience during COVID-19 outbreak for intravitreal injections in patients with maculopathy. We proposed a treatment priority levels and timings; the “High” priority level includes all monocular patients; the “Moderate” is assigned to all patients with an active macular neovascularization; the patients affected by diabetic macular edema or retinal vein occlusion belong to the “Low” class. This organization allowed us to treat the most urgent patients although the injections performed had a 91.7% drop compared to the same period of 2019.