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Objective To explore the efficacy of treating diabetic macular edema with aflibercept and ranibizumab. and to compare the effects of these two drugs on central macular thickness (CMT), best-corrected visual acuity (BCVA), and central macular volume (CMV). Methods From February 2021 to February 2023.100 patients with diabetic macular edema were admitted to the hospital and randomly divided into two groups using the envelope method: the observation group (50 patients, 50 eyes) treated with aflibercept, and the control group (50 patients, 50 eyes) treated with ranibizumab. The efficacy, CMT, BCVA,CMV, and com- plications of the two groups were compared. Results There was no statistically significant difference in the overall efficacy between the two groups (P>0.05). There was no significant difference in the pre-treatment values of CMT and CMV between the two groups (P>0.05). However, the CMT and CMV values at 4 and 8 months post-treatment were significantly lower in the observation group than in the control group (P< 0.05). There was no significant difference in BCVA values before treatment, and at 4 and 8 months after treatment between the two groups (P>0.05). The rates of complications such as cataract, vitreous hemorrhage. and conjunctivitis were similar between the two groups (P>0.05). Conclusion Both aflibercept and ranibizumab can be effective in treating diabetic macular edema. However, aflibercept has a more pronounced advantage in reducing CMT and decreasing CMV, with fewer complications. [ABSTRACT FROM AUTHOR]

Peiyu Xing,1,&ast; Bo Meng,2,&ast; Xiaojia Hu,1 Wei Qu,2 Shaowei Wang2 1Department of Ophthalmology, China Medical University the Fourth People’s Hospital of Shenyang, Shenyang, People’s Republic of China; 2Department of Ophthalmology, the 2nd Affiliated Hospital of Harbin Medical University, Harbin, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Shaowei Wang, Department of Ophthalmology, the 2nd Affiliated Hospital of Harbin Medical University, Harbin, People’s Republic of China, Email h04014@hrbmu.edu.cnObjective: To assess the functional and anatomical effects of transitioning to conbercept intravitreal injection (IVC) treatment in patients with diabetic macular edema (DME) who had inadequate responses to prior anti-vascular endothelial growth factor (anti-VEGF) injections.Methods: We retrospectively included eyes with persistent DME after at least 3 injections of intravitreal ranibizumab (IVR). The analysis included the assessment of best corrected visual acuity (BCVA) and central macular thickness (CMT) during 6 months after the switch.Results: A total of 30 patients (30 eyes) were included. CMT dropped sharply from 437.8± 40.67μm at baseline to 363.59± 45.09,312.52 ± 39.15, 278.51 ± 37.92, and 292.59 ± 38.09 after 1, 2, 3 and 6 months of IVC, respectively (p < 0.001). BCVA in log MAR units was significantly improved from 0.73± 0.15 at baseline to 0.50± 0.09,0.46± 0.72, 0.40± 0.06 and 0.48± 0.04 after 1, 2, 3 and 6 months, respectively (p < 0.001).Conclusion: Switching to Conbercept effectively improved visual and anatomical structure in DME patients who had not responded satisfactorily to previous anti-VEGF injections.Keywords: diabetic macular edema, anti-vascular endothelial growth factor, central macular thickness, best corrected visual acuity, DME, CMT, anti-VEGF, BCVA

Abstract Background Intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections are the standard of care for diabetic macular edema (DME), a common complication of diabetes. This study aimed to identify factors influencing DME intravitreal anti-VEGF treatment outcomes in real-world practice. Methods This was a multi-center retrospective observational study using medical chart review of participants receiving anti-VEGF injections for DME (N = 248). Demographic and clinical variables were assessed for association with best corrected visual acuity (BCVA) and central macular thickness (CMT) outcomes using regression models. Results There was a significant improvement in BCVA (p

Purpose: To investigate morphological changes of intraretinal cyst in association with visual acuity following treatment for diabetic macular edema. Methods: This retrospective study enrolled 105 eyes from 105 treatment naïve patients with diabetic macular edema following anti-vascular endothelial growth factor injections. Best-corrected visual acuity (BCVA) and optical coherence tomography (OCT) data were obtained at baseline, 1, 3, 6, and 12 months. The width and height of the largest intraretinal cyst (IRC) at all different visits were measured and were correlated to final visual acuity by receiver operating characteristic curve. The exudative feature was defined by the presence of hard exudates. Multivariate logistic regression was used to select the independent predictor for visual outcomes. Results: Intraretinal cyst width but not the cyst height after treatment at 1 month independently predicted final visual loss of ten letters or more (multivariate P = 0.009). The optimal cutoff value was 196 um with a sensitivity of 0.889 and a specificity of 0.656. Eyes with large IRC width using this cutoff were consistently larger than those with small IRC width through 12 months (P = 0.008, Mann–Whitney U test). Small IRC width < 196 um at 1 month was more likely to coexist with exudative feature (P = 0.011, Fisher's exact test). Among baseline factors, large IRC width predicted IRC width ≥ 196 um at 1 month (multivariate P < 0.001). Conclusion: Cyst morphology following intravitreal injection predicts visual outcomes. Eyes with IRC width ≥ 196 um after treatment at 1 month tends to be more degenerative, and less likely to coexist with exudative feature. [ABSTRACT FROM AUTHOR]

Background: Intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections are the standard of care for diabetic macular edema (DME), a common complication of diabetes. This study aimed to identify factors influencing DME intravitreal anti-VEGF treatment outcomes in real-world practice. Methods: This was a multi-center retrospective observational study using medical chart review of participants receiving anti-VEGF injections for DME (N = 248). Demographic and clinical variables were assessed for association with best corrected visual acuity (BCVA) and central macular thickness (CMT) outcomes using regression models. Results: There was a significant improvement in BCVA (p < 0.001) and CMT (p < 0.001) after 12 months of treatment, although 21% of participants had decreased BCVA, and 41% had a < 10% CMT reduction at 12 months. Higher baseline BCVA (p = 0.022, OR=-0.024, 95% CI=-0.046,-0.004) and longer duration of diabetic retinopathy (p = 0.048, OR=-0.064, 95% CI=-0.129,-0.001) were negative predictors for BCVA response, whereas Aflibercept treatment (p = 0.017, OR = 1.107, 95% CI = 0.220,2.051) compared with other drugs and a positive "early functional response" (p < 0.001, OR=-1.393, 95% CI=-1.946,-0.857) were positive predictors. A higher baseline CMT (p < 0.001, OR = 0.019, 95% CI = 0.012,0.0261) and an "early anatomical response", (p < 0.001, OR=-1.677, 95% CI=-2.456, -0.943) were predictors for greater reduction in CMT. Overall, the variables could predict only 23% of BCVA and 52% of CMT response. Conclusions: The study shows a significant proportion of DME patients do not respond to anti-VEGF therapy and identifies several clinical predictors for treatment outcomes. Trial registration: The study was approved through the Human Research Ethics Committee, University of Tasmania (approval number H0012902), and the Southern Adelaide Clinical Human Research Ethics Committee (approval number 86 − 067). [ABSTRACT FROM AUTHOR]

Purpose: To determine whether the response to the initial anti-vascular endothelial growth factor (anti-VEGF) injection to treat diabetic macular edema (DME) is significantly correlated with the response to the third consecutive monthly injection of the same anti-VEGF agent. Methods: Seventy eyes with DME that were treated with an anti-VEGF agent (16 eyes with 1.25-mg bevacizumab, 35 eyes with 0.5-mg ranibizumab, and 19 eyes with 2.0-mg aflibercept) were studied. They were treated with three consecutive monthly injections of one of the three anti-VEGF agents. The best-corrected visual acuity (BCVA) in the logarithm of the minimum angle of resolution (logMAR units) and the central macular thickness (CMT) were measured at the baseline, 1 week after the initial injection, and 1 month after the third consecutive monthly injection. The changes of both values from the baseline 1 week after the initial injection (day 7) and 1 month after the third monthly injection were determined. The significance of the correlations between the BCVA and the CMT was determined. Results: The mean BCVA improved significantly for all three agents (0.38 ± 0.22 logMAR units at the baseline to 0.27 ± 0.25 logMAR units) after the three monthly injections (p < 0.05, repeated ANOVA). For all cases, a moderate but significant correlation was found between the BCVA at day 7 and 1 month after the third injection (r = 0.58, p < 0.01; Spearman's rank correlation). No significant correlation was found for bevacizumab (r = 0.09, p = 0.73), moderate correlation was found for ranibizumab (r = 0.42, p < 0.05), and a strong correlation was found for aflibercept (r = 0.83, p < 0.001) between the BCVA at day 7 and at 1 month after the third injection. The mean CMT improved significantly for all three agents (481.9 ± 96.3 μm at the baseline to 364.1 ± 116.0 μm after the three monthly injections, p < 0.05), and a moderate correlation was found for the three agents between CMT at day 7 to that at one month after the third anti-VEGF injection (r = 0.54, p < 0.01). A moderate correlation was found for all three agents between CMT at day 7 to that at one month after the third anti-VEGF injection (r = 0.68 for bevacizumab, r = 0.41 for ranibizumab and r = 0.53 for aflibercept, p < 0.05). Conclusions: The significant correlations between the results on day 7 to that one month after the third anti-VEGF treatment for DME indicates that the long-term effects of anti-VEGF therapy can be predicted by the short-term response. In addition, the results indicate that there may be differences in the effectiveness between the three anti-VEGF agents. [ABSTRACT FROM AUTHOR]

Abstract Background To evaluate the efficacy and safety of different intravitreal corticosteroids for treating diabetic macular edema (DME). Methods Four databases were systematically searched for randomized controlled trials comparing different intravitreal corticosteroids for treating DME. The primary outcome was the change in best-corrected visual acuity (BCVA) within 6 months after the first injection (short-term BCVA). Secondary outcomes were the change in BCVA over 1 year (long-term BCVA) and changes in central macular thickness (CMT) and intraocular pressure (IOP) within 6 months after the first injection. Network meta-analysis was performed to aggregate the results from the individual studies. Results Nineteen trials involving 2839 eyes were included. Intravitreal triamcinolone acetonide (TA) injections (≥ 8 mg and 4–8 mg), fluocinolone acetonide (FA) implants (0.5 µg/day) and dexamethasone (DEX) implants (700 µg) improved short-term BCVA (mean changes in logMAR [95% confidence interval] − 0.27 [− 0.40, − 0.15]; − 0.12 [− 0.18, − 0.06]; − 0.10 [− 0.21, − 0.01]; and − 0.06 [− 0.11, − 0.01]). Intravitreal TA injections (4 mg, multiple times), FA implants (0.5 µg/day and 0.2 µg/day), and DEX implants (350 µg) improved long-term BCVA (mean changes in logMAR [95% confidence interval] − 0.11 [− 0.21, − 0.02]; − 0.09 [− 0.15, − 0.03]; − 0.09 [− 0.14, − 0.02]; and − 0.04 [− 0.07, − 0.01]). All intravitreal corticosteroids reduced CMT, and different dosages of TA did not show significant differences in increasing IOP. Conclusions Intravitreal corticosteroids effectively improved BCVA in DME patients, with higher dosages showing greater efficacies. TA was not inferior to FA or DEX and may be considered a low-cost alternative choice for DME patients. The long-term efficacy and safety of different corticosteroids deserve further investigation. Trial registration Prospectively registered: PROSPERO, CRD42020219870

Alaa Dweikat,1 Arkan Jarrar,1 Mohammad Akkawi,2,3 Mohammad Shehadeh,2,3 Ammar Aghbar,3 Jamal Qaddumi,1 Maha Akkawi1 1Department of Medicine, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine; 2Department of Special Surgeries, Faculty of Medicine and Health Sciences, An-Najah National University Hospital, An-Najah National University, Nablus, Palestine; 3Ophthalmology Department, An-Najah National University Hospital, Nablus, PalestineCorrespondence: Mohammad Akkawi; Alaa Dweikat Email m.akkawi@najah.edu; alaadweikat43@gmail.comPurpose: This article aims to evaluate how the subfoveal choroidal thickness (SFCT) and best-corrected visual acuity (BCVA) respond to the intravitreal injection of bevacizumab and to assess the correlation between these changes. It will also assess the use of the baseline SFCT as a predictor for BCVA changes in eyes of treatment-naive, diabetic macular edema (DME) patients.Methods: This retrospective, consecutive case series comprised 59 eyes of 39 treatment-naive DME patients. Complete slit-lamp assessment, swept-source optical coherence tomography (SS-OCT) scans to measure SFCT and BCVA values were performed at two stages: baseline and one month after the third monthly injection of intravitreal bevacizumab.Results: Patients’ ages ranged from 46.3 to 76.4 years (mean: 62.6 ± 2.3). The mean SFCT was 318 ± 82 μm at baseline, which decreased after 3 months to 300 ± 66 μm (P-value = 0.021). There was an improvement in the mean of the logMAR best-corrected visual acuity (BCVA) from 0.7 (decimal equivalent: 0.2) to 0.5 (decimal equivalent: 0.3) (P-value = 0.019). There was no association between SFCT changes and BCVA changes (P-value = 0.180). Wilcoxon signed-rank test disclosed that a better BCVA improvement was related to a greater subfoveal choroidal thickness at baseline P-value < 0.00.Conclusion: Eyes with a higher baseline subfoveal choroidal thickness (SFCT) attained greater BCVA improvement than eyes with a lower baseline SFCT. In addition to this, changes to SFCT do not appear to correlate with BCVA changes. These findings do not support using OCT SFCT changes as a prognostic factor for changes to BCVA after intravitreal bevacizumab treatment in evaluating treatment-naive DME eyes.Keywords: diabetic macular edema, subfoveal choroidal thickness, best-corrected visual acuity, bevacizumab, anti-vascular endothelial growth factor

Aims: To investigate the changes in vision-related quality of life after a loading dose of three consecutive intravitreal ranibizumab (IVR) injections in patients with unilateral diabetic macular edema (DME). Materials and Methods: Fifty-two eyes of 52 patients who received IVR injections in only one eye with DME were included in our study. The following characteristics of the patients were recorded: gender, education status, marital status, work status, presence of chronic disease. The changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT) were evaluated at baseline (before treatment) and 1 month after the third intravitreal injection (after treatment). Patients were administered the Turkish form of the National Eye Institute 25-Item Visual Functions Questionnaire (NEI VFQ-25 TR). The quality of life scores assessed by the NEI VFQ-25 TR, the BCVA, intraocular pressure (IOP), and CMT measurements were compared at baseline (before treatment) and 1 month after the third intravitreal injection (after treatment). Results: We enrolled 52 patients (25 females, 27 males) in our study; mean age was 64.35 ± 9.26 years. After treatment, BCVA improved significantly (p = 0.001), and macular thickness decreased significantly (p < 0.001). All NEI VFQ-25 TR subscale scores were significantly higher after treatment (p < 0.05). However, no significant correlation was found between the change in BCVA and CMT and the change in NEI VFQ-25 TR subscale and composite scores. The increase in near activities scores was significantly higher in males (p = 0.020) and in the retired group (p = 0.022). There were no significant differences in the changes in NEI VFQ-25 TR subscale and composite scores in relation to educational status. Discussion: Significant improvements in BCVA, macular edema, and vision-related quality of life were found in DME patients who received IVR injections with a loading dose, as shown by the NEI VFQ-25 TR. Interestingly, a significant improvement in quality of life was observed even though the patients could see well with the fellow eye. In conclusion, the NEI VFQ-25 TR is a useful scale to evaluate the changes in visual function and psychosocial characteristics of DME patients after treatment.

Elisabeth Van Aken,1,2 Mérédis Favreau,3 Eva Ramboer,3 Kris Denhaerynck,4,5 Karen MacDonald,4 Ivo Abraham,4,6– 8 Heidi Brié3 1Department of Ophthalmology, AZ Sint-Elisabeth, Zottegem, Belgium; 2Department of Head and Skin, Ghent University, Ghent, Belgium; 3Medical Department, Novartis Pharma, Vilvoorde, Belgium; 4Department of Research and Consulting, Matrix45, Tucson, AZ, USA; 5Department of Public Health, University of Basel, Basel, Switzerland; 6Center for Health Outcomes and Pharmacoeconomic Research, University of Arizona, Tucson, AZ, USA; 7Department of Pharmacy Practice and Science, College of Pharmacy, University of Arizona, Tucson, AZ, USA; 8Department of Family and Community Medicine, College of Medicine – Tucson, University of Arizona, Tucson, AZ, USACorrespondence: Heidi BriéN.V. Novartis Pharma S.A, Medialaan 40, B-1800 Vilvoorde, BelgiumTel +32.2.246.1774Email heidi.brie@novartis.comAim: Evaluate long-term real-world treatment patterns and associated effectiveness and safety outcomes in patients with diabetic macular edema (DME) treated ≥ 36 months with 0.5mg ranibizumab.Methods: Open-label observational effectiveness study in 9 Belgian clinics. Included were primary treated eyes of 55 DME patients between August 2014 and March 2015 and followed for 3.5± 1.8 years. Eyes were 21.8% treatment (TX)-naïve, 9.1% non-naïve with exclusive prior anti-VEGF treatment (PRIOR-anti-VEGF), and 63.6% non-naïve with other prior treatments (PRIOR-other). Intravitreal injections with ranibizumab were administered per ophthalmologists’ best clinical judgment. Trend testing of changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) over time occurred using mixed regression analysis.Results: The mean±SD number of treatments in the first year was 5.1± 3.0 (TX-naïve), 4.5± 2.7 (PRIOR-anti-VEGF) and 5.6± 3.1 (PRIOR-other). At 12 months, BCVA increased by 8.9± 16.4 letters from 59.7± 9.3 at baseline in TX-naïve (p< 0.0001), by 11.8± 9.9 from 61.6± 8.5 in PRIOR-anti-VEGF (p=0.03), and by 4.2± 10.6 from 58.2± 14.6 in PRIOR-other groups (p=0.0002). BCVA remained stable for the remainder of follow-up in all groups. CRT decreased over the first 2 months by monthly rates of − 43.8μm in TX-naïve (p=0.04), − 75.7μm in PRIOR-anti-VEGF (p=0.02), and − 65.8μm in PRIOR-other eyes (p=0.0003), showing stability afterwards. No unknown adverse events were recorded; a painful eye following injection was registered with a possible relationship to the treatment.Conclusion: This real-world study confirms the effectiveness of ranibizumab in preventing a decline in BCVA and demonstrated initial improvement and subsequent retention of BCVA in DME patients ≥ 36 months. Ranibizumab initially reduced and then maintained CRT. However, these data reveal that treatment intensity and BCVA and CRT outcomes are lower than those found in early efficacy trials. Under-treatment likely accounts for this efficacy-effectiveness gap. Yet, intravitreal ranibizumab is an effective and safe long-term treatment for DME under conditions of significant heterogeneity in patients and treatment patterns.Keywords: diabetic macular edema, ranibizumab, best-corrected visual acuity, central retinal thickness, long-term effectiveness

AIM: To analyze the correlation between macular morphology and function in eyes with diabetic macular edema (DME). METHODS: Fifty-five eyes with different visual acuity (VA) of 32 patients who suffered from DME were analyzed using multifocal electroretinography (mfERG) and optical coherence tomography (OCT). The parameters of mfERG including implicit times and response amplitude were compared to those of 50 normal eyes of 36 age-matched subjects. Correlation analysis was performed between VA, the parameters of mfERG including implicit times and response amplitude, and the central macular thickness (CMT). RESULTS: The amplitude of N1 and P1 were significantly decreased and their latency were significantly increased in five ring regions of the retina in patients with DME. There was statistically significant correlation between logMAR BCVA and P1 amplitude densities in rings 1-4 (r=-0.306, -0.536, -0.470, -0.362; P=0.023, 0.05) in the central macular ring. Multiple stepwise regression analysis showed that P1 amplitude density in ring 2 was the only contributor to the VA. CONCLUSION: It seems to be more appropriate of combining use of mfERG with OCT for the evaluation of macular function in eyes with DME.

Javier Zarranz-Ventura, 1, 2 Joshua O Mali 3 1Clinical Institute of Ophthalmology (ICOF), Hospital Clinic, Barcelona, Spain; 2August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain; 3The Eye Associates, Sarasota, FL, USACorrespondence: Javier Zarranz-VenturaClinical Institute of Ophthalmology (ICOF), Hospital Clinic, Barcelona, SpainTel +34 932 275 400Email jzarranz@hotmail.comPurpose: Calculations of area-under-the-curve (AUC) provide the average letters gained across the entire treatment period, which may be a better estimate of long-term effectiveness than single time-point outcomes, particularly when it comes to sustained-release therapies.Materials and Methods: The AUC method was used to compare the efficacy of the 0.2 μg/day fluocinolone acetonide (total dose of 0.19 mg; FAc) and dexamethasone (DEX) 700 μg implants based on published data from their respective Phase 3 FAME (Fluocinolone Acetonide for Macular Edema) and MEAD pivotal clinical trials in diabetic macular edema (DME). Best-corrected visual acuity (BCVA) letter scores were collated from the FAME trial and compared with those reported in MEAD. The trapezoidal rule was then used to calculate AUC, based on BCVA letter score, from baseline to Month 36 (FAME)/Month 39 (MEAD) and presented as an overall mean visual acuity change per day.Results: Treatment with either the FAc or DEX implant resulted in an improved BCVA over the treatment period compared with sham. This effect was statistically greater (p=0.029) for the FAc implant than the DEX implant (5.2 vs 3.5 letters/day, respectively) and even greater in the recurrent DME subgroup (p< 0.001; 6.9 vs 3.5 letters/day, respectively).Conclusion: Although direct comparisons between trial cohorts cannot be performed, this analysis indicated that, in their respective pivotal clinical trial cohorts, treatment with the FAc implant provides better long-term visual acuity outcomes and a lower treatment burden than achieved with the DEX implant.Keywords: area-under-the-curve, best-corrected visual acuity, diabetic macular edema, corticosteroid, fluocinolone acetonide implant, dexamethasone implant

Aims: To investigate the changes in vision-related quality of life after a loading dose of three consecutive intravitreal ranibizumab (IVR) injections in patients with unilateral diabetic macular edema (DME). Materials and Methods: Fifty-two eyes of 52 patients who received IVR injections in only one eye with DME were included in our study. The following characteristics of the patients were recorded: gender, education status, marital status, work status, presence of chronic disease. The changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT) were evaluated at baseline (before treatment) and 1 month after the third intravitreal injection (after treatment). Patients were administered the Turkish form of the National Eye Institute 25-Item Visual Functions Questionnaire (NEI VFQ-25 TR). The quality of life scores assessed by the NEI VFQ-25 TR, the BCVA, intraocular pressure (IOP), and CMT measurements were compared at baseline (before treatment) and 1 month after the third intravitreal injection (after treatment). Results: We enrolled 52 patients (25 females, 27 males) in our study; mean age was 64.35 ± 9.26 years. After treatment, BCVA improved significantly (p = 0.001), and macular thickness decreased significantly (p < 0.001). All NEI VFQ-25 TR subscale scores were significantly higher after treatment (p < 0.05). However, no significant correlation was found between the change in BCVA and CMT and the change in NEI VFQ-25 TR subscale and composite scores. The increase in near activities scores was significantly higher in males (p = 0.020) and in the retired group (p = 0.022). There were no significant differences in the changes in NEI VFQ-25 TR subscale and composite scores in relation to educational status. Discussion: Significant improvements in BCVA, macular edema, and vision-related quality of life were found in DME patients who received IVR injections with a loading dose, as shown by the NEI VFQ-25 TR. Interestingly, a significant improvement in quality of life was observed even though the patients could see well with the fellow eye. In conclusion, the NEI VFQ-25 TR is a useful scale to evaluate the changes in visual function and psychosocial characteristics of DME patients after treatment. [ABSTRACT FROM AUTHOR]

Purpose: To assess the efficacy, safety, and follow-up of 36-month treatment with ranibizumab in patients with diabetic macular edema (DME) in real-life setting. Methods: This is a prospective phase 4 observational study. Between December 2013 and April 2015, 84 ophthalmologists enrolled a total of 290 adult patients initiating ranibizumab for visual impairment due to DME and treated them according to their routine practice. The primary outcome (mean change in best-corrected visual acuity [BCVA] after 12 months) was previously reported. Here, we present outcomes after 36 months of follow-up for BCVA and change in central subfield thickness (CSFT) and report how participating ophthalmologists treated DME over a 3-year period (number of visits and injections and evolution of treatment strategy). Results: Of the 290 patients enrolled, 187 (64.5%) completed the 36 months of the study (entire cohort). In the entire cohort, 97 patients were treated exclusively with ranibizumab throughout the study, and 90 patients switched to other intravitreal treatments. Mean BCVA was 64.2 (20.1) letters, representing a gain of +4.1 (19.9) letters from baseline to month 36 (M36). CSFT improved over the study, and by M36 had decreased by 127 (138) µm compared to baseline. Over the 36 months of follow-up, patients in the entire cohort paid their ophthalmologists a mean of 30.9 (12.2) visits and had a mean of 7.6 (5.2) any injections. Results for quality of life questionnaires NEI-VFQ25 and HUI-3 remained stable throughout the study. Multivariate analysis on the 145 patients with evaluable BCVA data at M36 found that male gender and milder baseline DME characteristics (BCVA ≥59 and CSFT <500 µm) were predictive factors for achieving a BCVA of ≥70 letters at M36. This study did not find any new safety signals, compared to the known profile of ranibizumab. Conclusions: Gains in BCVA in this real-life study were lower than those observed in randomized clinical trials with ranibizumab, mainly due to undertreatment. Safety analysis of ranibizumab did not yield any new safety concerns. [ABSTRACT FROM AUTHOR]

AIM: To evaluate the efficacy of intravitreal injection of conbercept (IVC) and ranibizumab (IVR) in patients with diabetic macular edema. METHODS: Reviewers have searched 12 databases, including PubMed, Medline, EMBASE, Web of Science, Springer, ScienceDirect, OVID, Cochrane Library, ClinicalTrials.gov, cqVIP, WanFangdata and China National Knowledge Infrastructure (CNKI), up to December 28, 2018. RevMan 5.3 (Cochrane Library Software, Oxford, UK) was employed for statistical analysis. Fixed and random effects models were applied to assess heterogeneity. Odds ratio (OR) was applied for dichotomous variables; weighted mean difference (WMD) was applied for continuous variables. The confidence interval (CI) was set at 95%. Central macular thickness (CMT) and best-corrected visual acuity (BCVA) were employed to analyze the improvement of DME patients. Inclusion criteria for picking out studies were retrospective studies and randomized controlled trials (RCTs) that compared IVC and IVR for the treatment of diabetic macular edema. RESULTS: Four retrospective studies and five RCTs were included with a total of 609 patients. No statistically significant difference was observed in mean CMT and mean BCVA in the baseline parameters [BCVA (WMD: -0.48; 95%CI: -1.06 to 0.10; P=0.1), CMT (WMD: -0.83; 95%CI: -15.15 to 13.49; P=0.91). No significant difference was found in the improvement of BCVA and adverse event (AE) in IVC group, compared with IVR group after treatment of loading dosage [the 1st month BCVA (WMD: 0.01; 95%CI: -0.26 to 0.27; P=0.96), the 3rd month BCVA (WMD: -0.04; 95%CI: -0.14 to 0.06; P=0.46); the 6th month BCVA (WMD: -0.24; 95%CI: -1.62 to 1.14; P=0.73)], AE (OR: 0.84; 95%CI: 0.38 to 1.84; P=0.66)]. A slight difference was found in the effectiveness rate (OR: 1.70; 95%CI: 0.97 to 2.96; P=0.06), There were statistically significant differences between IVC and IVR treatment in terms of CMT [1st month CMT (WMD: -19.88; 95%CI: -27.94 to -11.82; P

Aims: To compare the efficacy of five kinds of antiangiogenic drugs in the treatment of diabetic macular edemaMethods: A comprehensive search of seven databases without language restrictions includes PubMed, EMBASE, Web of Science, CBM, the Cochrane Library, CNKI, and WanFang date. All literature used was published before October 2020. Eligible randomized trials were screened for inclusion in this study, and Bayesian framework was used to perform a network meta-analysis (NMA). Data on the mean change of best-corrected visual acuity (BCVA), central macular thickness (CMT) and intraocular pressure (IOP) at 6 months were extracted.Results: 25 randomized controlled trials (RCTs) that covered 2214 eyes, which received treatment of more than 3 months durations were included. In the pooled pair-wise meta-analysis, there was no statistically significant difference between all treatments. The same result was observed in the network meta-analysis with 0–37.82% Global I-squared. For BCVA at 6 months, conbercept and ranibizumab may be favorable than bevacizumab, aflibercept, triamcinolone acetonide and sham injections according to the ranking probabilities. As for CMT at 6 months, ranibizumab may be the most effective compared to bevacizumab, aflibercept and triamcinolone acetonide. In terms of IOP at 6 months, ranibizumab have better effect than bevacizumab, triamcinolone acetonide and sham injections. The results of sensitivity analysis also confirm it.Conclusion: The analysis confirms that ranibizumab may be the most favorable for BCVA improvement and have a stronger efficacy in decreasing CMT and IOP than other drugs when taking all the indicators into consideration. This conclusion may provide clinical evidence to guide treatment decisions. However, more high-quality randomized controlled trials will be necessary to further confirm this.

Purpose: To compare the visual and anatomical outcomes between intravitreal aflibercept and ranibizumab for diabetic macular edema Methods: A total of 194 eyes from 194 patients (aflibercept n = 95, ranibizumab n = 99) were retrospectively enrolled in the study. All eyes fulfilled the key criteria including a baseline best-corrected visual acuity (BCVA) between 20 and 70 ETDRS letters, a central subfield thickness (CST) 300 µm or more. Primary outcomes were BCVA and CST at 1, 3, 6, and 12 months. Maintenance of vision was defined as visual loss of less than 5 letters over 6 to 12 months. Predictors for final visual acuity and visual maintenance were analyzed using multivariate regression models. Results: Both agents achieved comparable visual and anatomical outcomes at any time point over the course of follow-up (all p >.05). At 12 months, aflibercept group had higher proportions of visual gains 5, 10 and 15 letters or more (p =.014, p =.011, and p =.034, respectively). The mean number of injections was 5.0 ± 1.9 in ranibizumab group and 4.5 ± 1.9 in aflibercept group (p =.09). Ranibizumab predicted poor maintenance of vision (p =.009), but not the final visual acuity (univariate p =.1). Ranibizumab was more likely to have recurrence of subretinal fluid than aflibercept in 12 months after resolution of subretinal fluid at baseline (p =.016). Both aflibercept and ranibizumab had similar rates of loss to follow-up (p =.47) and occurrence of vitreous hemorrhage (p =.21). Conclusion: While both agents improved vision with resolution of edema, aflibercept maintained vision more effectively with less recurrence of subretinal fluid at 12 months in real-world settings. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of the study is to describe visual and anatomic outcomes of 5774nm micropulse laser photocoagulation in eyes with either treatment-naïve or refractory diabetic macular edema (DME) at 3 months. Methods: This was a prospective case series that recruited 23 consecutive patients (33 eyes) with center-involved DME that was either treatment-naïve or had not responded to prior treatment. Micropulse therapy was performed with the Easy Ret 577 (Quantel Medical, Cournon d'Auvergne, France) diode laser in a high-density manner in eyes with treatment-naïve or refractory DME. The primary outcome was the change of best-corrected visual acuity (BCVA; logMAR) at 1 and 3 months. Secondary outcomes were changes in the central macular thickness (CMT), thickness area, macular volume, and macular capillary leakage at 1 and 3 months. Results: There were no significant changes in BCVA at 3 months, with mean ± standard deviation (SD) of −0.08 ± 0.01 (p = 0.228) and + 0.01 ± 0.01 (p = 0.969) for treatment-naïve and refractory groups, respectively. The change in CMT at 3 months was statistically but not clinically significant in the treatment-naïve group only (mean ± SD; –30 ± 130 µm; p = 0.011). The macular volume and area thickness change were not statistically significant (p = 0.173 and p = 0.148 for macular volume and area thickness, respectively) in the treatment-naïve group. There was no difference concerning the leakage area in both groups. No adverse events were reported. Conclusion: We concluded that micropulse 577nm laser therapy maintained the visual acuity and macular thickness at 3 months in both treatment-naïve and refractory DME. [ABSTRACT FROM AUTHOR]

Aim: Evaluate long-term real-world treatment patterns and associated effectiveness and safety outcomes in patients with diabetic macular edema (DME) treated ≥ 36 months with 0.5mg ranibizumab. Methods: Open-label observational effectiveness study in 9 Belgian clinics. Included were primary treated eyes of 55 DME patients between August 2014 and March 2015 and followed for 3.5± 1.8 years. Eyes were 21.8% treatment (TX)-naïve, 9.1% non-naïve with exclusive prior anti-VEGF treatment (PRIOR-anti-VEGF), and 63.6% non-naïve with other prior treatments (PRIOR-other). Intravitreal injections with ranibizumab were administered per ophthalmologists' best clinical judgment. Trend testing of changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) over time occurred using mixed regression analysis. Results: The mean±SD number of treatments in the first year was 5.1± 3.0 (TX-naïve), 4.5± 2.7 (PRIOR-anti-VEGF) and 5.6± 3.1 (PRIOR-other). At 12 months, BCVA increased by 8.9± 16.4 letters from 59.7± 9.3 at baseline in TX-naïve (p< 0.0001), by 11.8± 9.9 from 61.6± 8.5 in PRIOR-anti-VEGF (p=0.03), and by 4.2± 10.6 from 58.2± 14.6 in PRIOR-other groups (p=0.0002). BCVA remained stable for the remainder of follow-up in all groups. CRT decreased over the first 2 months by monthly rates of − 43.8μm in TX-naïve (p=0.04), − 75.7μm in PRIOR-anti-VEGF (p=0.02), and − 65.8μm in PRIOR-other eyes (p=0.0003), showing stability afterwards. No unknown adverse events were recorded; a painful eye following injection was registered with a possible relationship to the treatment. Conclusion: This real-world study confirms the effectiveness of ranibizumab in preventing a decline in BCVA and demonstrated initial improvement and subsequent retention of BCVA in DME patients ≥ 36 months. Ranibizumab initially reduced and then maintained CRT. However, these data reveal that treatment intensity and BCVA and CRT outcomes are lower than those found in early efficacy trials. Under-treatment likely accounts for this efficacy-effectiveness gap. Yet, intravitreal ranibizumab is an effective and safe long-term treatment for DME under conditions of significant heterogeneity in patients and treatment patterns. [ABSTRACT FROM AUTHOR]

Intravitreal anti-VEGF injections are the current gold standard for treating diabetic macular edema (DME). However, injection practice patterns of retina specialists have varied markedly based on physician discretion. This retrospective study analyzes the impact of injection protocol selection on change in best-corrected visual acuity (BCVA) and central macular thickness (CMT) in 170 eyes treated by 4 retina specialists practicing a pro re nata (PRN) strategy between 2010 and 2020. DME patients received an average of 7.25 injections every 6.24 weeks over 56.6 weeks. There were significant differences between retina specialists in mean number of injections (p = 0.0001) and mean length of treatment (p = 0.0007) but not in mean interval between injections. Over the treatment period, average change in BCVA was −0.053 logMAR, and average change in CMT was −51.1 µm, neither of which had significant differences between retina specialists. BCVA and CMT at initial visit were found to be significantly associated with improved BCVA and CMT over the treatment period (p < 0.001). Number of injections administered and interval between injections were not found to be significant factors affecting change in BCVA or CMT. Despite significant differences in injection dosing regimen, retina specialists achieved similar outcomes in change in BCVA and CMT over the treatment period.

Aims: Fluocinolone acetonide (FAc) is an intravitreal corticosteroid implant approved for the second-line treatment of diabetic macular edema (DME). This study compared outcomes of patients with DME switched directly to an FAc implant, versus indirectly via dexamethasone, after anti-VEGF therapy failure. Methods: This is a retrospective, single-center chart review. Patients were assigned to Group A (switched to FAc after anti-VEGF) or Group B (switched to dexamethasone and then to FAc after > 4 months). Charts were reviewed for best-corrected visual acuity (BCVA), central macular thickness (CMT), intraocular pressure (IOP) and cataract development. Results: Forty-nine eyes were included. BCVA increased and CMT decreased with anti-VEGF (both groups), and dexamethasone (Group B only), but regressed after stopping treatment. With FAc, BCVA increased rapidly and significantly: increases were maintained up to 36 months (P < 0.001), except at 18 and 9 months in Groups A and B, respectively. Significant CMT reductions (P < 0.001) were evident after 3 months and maintained up to 36 months in both groups. IOP increase > 21 mmHg occurred in 14 patients (nine in Group A, five in Group B): all were sufficiently treated with IOP-lowering drops. Nineteen phakic eyes (73.1%) developed cataract: seven underwent phaco-emulsification (two in Group A, five in Group B). Conclusions: Similar functional and anatomical improvements occurred in FAc-treated eyes, regardless of whether they first received dexamethasone or switched directly to FAc after anti-VEGF. Safety signals were consistent with corticosteroid class effects. Early switch to FAc could benefit patients who respond insufficiently to anti-VEGF. [ABSTRACT FROM AUTHOR]

• This is the first prospective, multi-center, open label randomized controlled study on the optimal dosage and frequency of anti-VEGF agent (Conbercept) injections in treating diabetic macular edema (DME). • Patients were randomized 1:1 to three or six doses initial Conbercept treatments. Additional injections were administered pro re nata (PRN) over 12 months. • Patients in both 3 + PRN or 6 + PRN treatments experienced similar best-corrected visual acuity (BCVA) gain and anatomical improvement. • Over 12 months, eyes in the 6 + PRN group received better changes of the deep capillary plexus. • Age significantly affected visual outcome in 3 + PRN group, while the initial central macular thickness (CMT) and foveal avascular zone (FAZ) area associated with visual outcome in 6 + PRN group. Duration of diabetes exhibited significant results on CMT among 3 + PRN group. The optimal treatment regimen for diabetic macular edema (DME) and predictors for its treatment's outcome need emerging evidence but currently poorly studied. A prospective, multicenter, open label randomized controlled study among adult patients with DME was conducted. Eyes were randomized to three or six doses initial Conbercept treatments. Additional injections were suggested pro re nata (PRN) over 12 months. Optical coherence tomography angiography (OCTA) was adopted to quantify the macular vessel density. Visual acuity gain and anatomical improvement and their associated factors were evaluated by multivariable linear regression. 41 patients with 59 eyes participated in current study. Patients in both 3 + PRN (n = 32 eyes) or 6 + PRN (n = 27 eyes) treatments experienced similar best-corrected visual acuity (BCVA) gain and anatomical improvement, including the central macular thickness, foveal avascular aone (FAZ) and the retinal vessel density. Over 12 months, eyes in the 6 + PRN group received better changes of the deep capillary plexus (2.53 ± 5.45%). In multivariate linear regression, the age significantly affected visual outcome in 3 + PRN group (β = -0.014, P = 0.028), while the initial CMT (β = -0.001, P = 0.022) and FAZ area (β = -0.946, P = 0.007) associated with visual outcome in 6 + PRN group. Furthermore, the duration of diabetes exhibited significant results on CMT among 3 + PRN group (β= -7.516, P = 0.04). Both 3 + and 6 + initial treatment regimens of Conbercept loading dose achieved parallel anatomical and functional visual improvement, while 6 + group had a trend of better treatment outcome. Older age, higher initial CMT and longer duration of diabetes might influence the clinical outcomes over 12 months from baseline. [ABSTRACT FROM AUTHOR]

Javier Zarranz-Ventura,1 Joshua O Mali2 1Institut Clínic d’Oftalmología (ICOF), Hospital Clinic, Barcelona, Spain; 2The Eye Associates, Sarasota, FL, USACorrespondence: Javier Zarranz-VenturaInstitut Clínic d’Oftalmología (ICOF), Hospital Clinic, Barcelona, SpainTel +34 932 279 391Email jzarranz@hotmail.com With interest, we read the letter to the Editor regarding the Effectiveness of 190 μg fluocinolone acetonide versus 700 μg dexamethasone intravitreal implants in diabetic macular edema using the area-under-the-curve method: The CONSTANT analysis by Stewart and Taylor published in Clinical Ophthalmology. The key concerns raised by the authors relate to the design deficiencies of the MEAD studies1 and highlight two specific issues – the six month dosing of the dexamethasone implant and the potentially delayed removal of cataracts. View the original paper by Zarranz-Ventura and Mali This is in response to the Letter to the Editor

Purpose: To report the real-world effectiveness and safety of ranibizumab 0.5 mg in patients with visual impairment due to diabetic macular edema (DME). Methods: This is a French, 36-month, multicenter, observational cohort study. Between December 2013 and April 2015, ophthalmologists enrolled diabetic patients aged ≥18 years with DME-related visual impairment and for whom ranibizumab 0.5 mg was initiated. Here, we present the 12-month results from this cohort. The primary endpoint was the mean change in best-corrected visual acuity (BCVA); sample size calculations were based on RESTORE trial data (BCVA mean change = 6.8 letters, preci sion = 0.7 letters). Secondary endpoints included the change in central subfield thickness (CSFT), number of visits, number of injections received, and frequency of ocular and nonocular adverse events and serious adverse events. Results: Between December 2013 and April 2015, a total of 290 patients with DME were enrolled by 84 ophthalmologists; 12-month data are available for 242 patients (due to low recruitment rates, precision was recalculated for 242 evaluable patients: the precision was then of 1.0 letters). Mean age (± standard deviation) was 66.1 ± 11.0 years and 56.6% were male. The mean baseline BCVA and CSFT were 59.2 letters (95% confidence interval [CI] 57.3, 61.0) and 457 μm (95% CI: 438, 476), respectively. At month 12, the mean gain in BCVA from baseline was 7.4 letters (95% CI: 5.4, 9.4), with 36.8% of patients with BCVA > 70 letters versus 13.2% at baseline. Mean change in CSFT was −125 μm (95% CI: −146, −103). The mean number of ranibizumab injections was 5.1 ± 2.3 over an average of 10.4 ± 3.0 visits. No new safety findings were identified. Conclusions: The BOREAL study confirms the effectiveness and safety of ranibizumab for the treatment of DME-related visual impairment in routine clinical practice with fewer injections than reported in clinical trials. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the visual and anatomical outcomes of intravitreal ranibizumab for diabetic macular edema (DME) in the healthcare system of Taiwan. Methods: A total of 39 eyes from 39 patients were retrospectively enrolled in the study. All eyes that fulfilled the key criteria, including a baseline vision between 20 and 70 ETDRS letters and a minimum central macular thickness (CMT) of 300 µm, had at least 3 monthly loading injections of ranibizumab in a year. Macular laser or posterior subtenon injections of triamcinolone acetonide (PSTA) could be performed as supplementary treatments following loading injections. Primary outcomes include best-corrected visual acuity and CMT. Results: Patients' vision improved from 46.5 ± 15.3 letters at baseline to 51.4 ± 16.6 letters at 12 months (p = 0.031). Mean CMT at baseline was 406 ± 105 µm, which decreased to 329 ± 108 µm (p = 0.002). At 12 months, 44.4% of eyes with total injection number < 5 and 42.9% with injection number ≥ 5 achieved a gain in vision that was 10 letters or more. A total of 5 injections or more did not lead to a better visual gain in comparison with only 3–4 injections (p = 0.71), and both had similar number of supplementary treatments (p = 0.43). Monthly reinjections of ranibizumab resulted in a lower likelihood of visual loss of 10 or 15 letters (p = 0.019 and 0.015, respectively, adjusted for age, baseline vision, severity of diabetic retinopathy and the presence of previous treatments); however, supplementary macular lasers, PSTA or ranibizumab without monthly reinjections did not (all p > 0.05). The average number of injections was 4.3 ± 1.0. Conclusion: Treatment for DME with at least three monthly ranibizumab loading injections, with or without other supplementary treatments, is effective at 12 months thereafter. Two monthly reinjections of ranibizumab, while not significantly increasing vision, may have a role in preventing visual loss. [ABSTRACT FROM AUTHOR]

Toshiyuki Oshitari, Sakiko Nonomura, Miyuki Arai, Yoko Takatsuna, Eiju Sato, Takayuki Baba, Shuichi Yamamoto Department of Ophthalmology and Visual Science, Graduate School of Medicine, Chiba University, Chuo-ku, Chiba, Japan Purpose: To compare the effects of sub-Tenon's capsule triamcinolone acetonide (STTA) injection to that of STTA injection combined with microaneurysm photocoagulation (MAPC; STTA + MAPC) on eyes with diabetic macular edema (DME). Patients and methods: The medical records of 138 eyes of 138 patients with DME treated by either STTA or STTA + MAPC were reviewed. The degree of DME was determined by the optical coherence tomographic features: patients with serous retinal detachment (SRD+; 38 eyes) and patients without SRD (non-SRD; 100 eyes). The central macular thickness (CMT) and the best-corrected visual acuity (BCVA) were measured periodically for 6 months after the treatments. Results: The BCVA was significantly improved in the non-SRD group after STTA + MAPC. The CMT was significantly improved in all groups and improved considerably more in the non-SRD group than in the SRD+ group after STTA + MAPC. Conclusion: Our findings indicate that MAPC has an additive effect in the non-SRD type. Keywords: diabetic macular edema, sub-Tenon's triamcinolone acetonide injection, microaneurysm photocoagulation, best-corrected visual acuity, central macular thickness

Objectives: To compare the intravitreal injections of 4 mg/0.1mL and 20 mg/0.1 mL triamcinolone acetonide with respect to efficacy and side effects in the treatment of diabetic macular edema (DME). Materials and Methods: A total of 56 pseudophakic eyes of 56 patients with the diagnosis of DME were evaluated retrospectively. Twenty-eight eyes were randomly injected with 4 mg of intravitreal triamcinolone (IVTA) (group 1), while 28 eyes were applied 20 mg IVTA (group 2). The patients were evaluated before the injection and were followed up monthly for 6 months and in the 8th month afterwards. Best-corrected visual acuity (BCVA), central macular thickness (CMT), intraocular pressure (IOP), and complication rates were determined and compared between the two groups. Results: When compared in terms of BCVA, there was a statistically significant increase in both groups (p

Background: Diabetic Macular Edema (DME) is one of the major causes of visual loss and increase in central macular thickness (CMT). The aim of this study was to determine the efficacy of a single intravitreal injection of bevacizumab (IVB) alone or in combination with intravitreal triamcinolone acetonide (IVB/IVT) versus macular laser photocoagulation (MPC) as primary treatment for DME when confounders were considered. Methods: Skew-symmetric bivariate mixed modeling according to best corrected visual acuity (BCVA) and CMT was done on the data of 103 diabetic patients from ophthalmic research center of Labbafinejad medical center (Tehran, Iran) to determine the best DME treatment by adjusting the effect of confounders. Results: Although there was no significant difference between IVB/IVT (p > 0.05), these two treatments increased BCVA and decreased CMT better than MPC (p < 0.05). The following three groups showed better treatment responses: 1) women, 2) patients with more diabetes duration, 3) patients whose CMT were higher and VA were lower at the beginning of the clinical trial. Conclusions: Using skew-symmetric mixed effect model as updated statistical method in presence of asymmetric or outlier data, we received different results compared to the same investigation on this study by analyzing BCVA and CMT simultaneously. This research demonstrated the effect of IVB alone or in combination with intravitreal IVB/IVT on visual power and decreasing CMT during follow up.

The article discusses a study related to correlation of baseline visual acuity (VA) with VA outcome in response to anti-vascular endothelial growth factor (VEGF) in diabetic macular edema. It mentions analysis of the relevance of VA gain comparisons across trials. It also highlights role of cross-trial comparisons on the basis of changes in best-corrected visual acuity.

Purpose: To compare the effects of sub-Tenon's capsule triamcinolone acetonide (STTA) injection to that of STTA injection combined with microaneurysm photocoagulation (MAPC; STTA + MAPC) on eyes with diabetic macular edema (DME). Patients and methods: The medical records of 138 eyes of 138 patients with DME treated by either STTA or STTA + MAPC were reviewed. The degree of DME was determined by the optical coherence tomographic features: patients with serous retinal detachment (SRD+; 38 eyes) and patients without SRD (non-SRD; 100 eyes). The central macular thickness (CMT) and the best-corrected visual acuity (BCVA) were measured periodically for 6 months after the treatments. Results: The BCVA was significantly improved in the non-SRD group after STTA + MAPC. The CMT was significantly improved in all groups and improved considerably more in the non- SRD group than in the SRD+ group after STTA + MAPC. Conclusion: Our findings indicate that MAPC has an additive effect in the non-SRD type. [ABSTRACT FROM AUTHOR]

Background: Iluvien® is a novel, nonbiodegradable, sustained-release drug delivery system (0.2μg/d fluocinolone acetonide [FAc]) indicated in Europe for the treatment of vision impairment associated with chronic diabetic macular edema (DME), considered insufficiently responsive to available therapies. Objective: To evaluate the safety and efficacy of 190-μg FAc implant in patients with chronic DME refractory to other medical treatment options in a clinical setting. Methods: Retrospective registry data were collected by using standard case report forms (CRFs). Prior to intravitreal injection of the FAc implant, all patients were treated either with a vascular endothelial growth factor (VEGF) antagonist and/or a steroid (triamcinolone, dexamethasone implant). Patients were excluded from receiving FAc if they had a known history of elevated intraocular pressure (IOP) following corticosteroid therapy, glaucoma, ocular hypertension, or any contraindications cited in the summary of product characteristics. Best-corrected visual acuity (BCVA) was the main study parameter. Central fovea thickness (CFT) and IOP were measured concurrently. These parameters were recorded prior to and after the injection of the 190-μg FAc implant (between 1 week and 9 months). Injections were performed between May 2013 and March 2014. Results: Fifteen eyes from ten patients were treated. Thirteen eyes (nine patients) were pseudophakic, and seven eyes (five patients) were vitrectomized prior to receiving therapy. BCVA improved in eleven eyes (73.3%), remained unchanged in two eyes (13.3%), and decreased slightly in two eyes (13.3%) at the last follow-up visit versus baseline levels. IOP increased in two patients and was controlled using fixed-combination of IOP-lowering eyedrops or sectorial cyclocryotherapy (n=1). Conclusion: The 190-μg FAc implant was efficacious and showed a favorable benefit-to-risk profile in the patient population with chronic DME of this case series that were refractory to other therapies. The longer-term efficacy and safety in a real-life setting is still being assessed in this center. FAc may offer an important treatment option for patients with chronic DME refractory to other treatment options. [ABSTRACT FROM AUTHOR]

Objectives: To compare the intravitreal injections of 4 mg/0.1mL and 20 mg/0.1 mL triamcinolone acetonide with respect to efficacy and side effects in the treatment of diabetic macular edema (DME). Materials and Methods: A total of 56 pseudophakic eyes of 56 patients with the diagnosis of DME were evaluated retrospectively. Twenty-eight eyes were randomly injected with 4 mg of intravitreal triamcinolone (IVTA) (group 1), while 28 eyes were applied 20 mg IVTA (group 2). The patients were evaluated before the injection and were followed up monthly for 6 months and in the 8th month afterwards. Best-corrected visual acuity (BCVA), central macular thickness (CMT), intraocular pressure (IOP), and complication rates were determined and compared between the two groups. Results: When compared in terms of BCVA, there was a statistically significant increase in both groups (p<0.05). This increase lasted for 4 months in group 1, whereas it lasted for 6 months in group 2. Mean CMT decreased till the 4th month in group 1, while it lasted till the 5th month in group 2, and these findings were statistically significantly different (p<0.05). There was significant IOP spikes in both groups (p<0.05). Increase in IOP was observed till the 5th month, but a return to baseline values was determined in the 6th month. Conclusion: High-dose IVTA injections seem to have longer efficacy in terms of BCVA and CMT. However, studies which consist of larger groups of patients and longer follow-up period are needed for determining appropriate IVTA dosages in the treatment of DME. [ABSTRACT FROM AUTHOR]

BACKGROUND: Diabetic Macular Edema (DME) is one of the major causes of visual loss and increase in central macular thickness (CMT). The aim of this study was to determine the efficacy of a single intravitreal injection of bevacizumab (IVB) alone or in combination with intravitreal triamcinolone acetonide (IVB/IVT) versus macular laser photocoagulation (MPC) as primary treatment for DME when confounders were considered. METHODS: Skew-symmetric bivariate mixed modeling according to best corrected visual acuity (BCVA) and CMT was done on the data of 103 diabetic patients from ophthalmic research center of Labbafinejad medical center (Tehran, Iran) to determine the best DME treatment by adjusting the effect of confounders. RESULTS: Although there was no significant difference between IVB/IVT (p > 0.05), these two treatments increased BCVA and decreased CMT better than MPC (p < 0.05). The following three groups showed better treatment responses: 1) women, 2) patients with more diabetes duration, 3) patients whose CMT were higher and VA were lower at the beginning of the clinical trial. CONCLUSIONS: Using skew-symmetric mixed effect model as updated statistical method in presence of asymmetric or outlier data, we received different results compared to the same investigation on this study by analyzing BCVA and CMT simultaneously. This research demonstrated the effect of IVB alone or in combination with intravitreal IVB/IVT on visual power and decreasing CMT during follow up. [ABSTRACT FROM AUTHOR]

Intravitreal anti-VEGF injections are the current gold standard for treating diabetic macular edema (DME). However, injection practice patterns of retina specialists have varied markedly based on physician discretion. This retrospective study analyzes the impact of injection protocol selection on change in best-corrected visual acuity (BCVA) and central macular thickness (CMT) in 170 eyes treated by 4 retina specialists practicing a pro re nata (PRN) strategy between 2010 and 2020. DME patients received an average of 7.25 injections every 6.24 weeks over 56.6 weeks. There were significant differences between retina specialists in mean number of injections (p = 0.0001) and mean length of treatment (p = 0.0007) but not in mean interval between injections. Over the treatment period, average change in BCVA was −0.053 logMAR, and average change in CMT was −51.1 µm, neither of which had significant differences between retina specialists. BCVA and CMT at initial visit were found to be significantly associated with improved BCVA and CMT over the treatment period (p < 0.001). Number of injections administered and interval between injections were not found to be significant factors affecting change in BCVA or CMT. Despite significant differences in injection dosing regimen, retina specialists achieved similar outcomes in change in BCVA and CMT over the treatment period. [ABSTRACT FROM AUTHOR]

Aims: To compare the efficacy of five kinds of antiangiogenic drugs in the treatment of diabetic macular edema Methods: A comprehensive search of seven databases without language restrictions includes PubMed, EMBASE, Web of Science, CBM, the Cochrane Library, CNKI, and WanFang date. All literature used was published before October 2020. Eligible randomized trials were screened for inclusion in this study, and Bayesian framework was used to perform a network meta-analysis (NMA). Data on the mean change of best-corrected visual acuity (BCVA), central macular thickness (CMT) and intraocular pressure (IOP) at 6 months were extracted. Results: 25 randomized controlled trials (RCTs) that covered 2214 eyes, which received treatment of more than 3 months durations were included. In the pooled pair-wise meta-analysis, there was no statistically significant difference between all treatments. The same result was observed in the network meta-analysis with 0–37.82% Global I-squared. For BCVA at 6 months, conbercept and ranibizumab may be favorable than bevacizumab, aflibercept, triamcinolone acetonide and sham injections according to the ranking probabilities. As for CMT at 6 months, ranibizumab may be the most effective compared to bevacizumab, aflibercept and triamcinolone acetonide. In terms of IOP at 6 months, ranibizumab have better effect than bevacizumab, triamcinolone acetonide and sham injections. The results of sensitivity analysis also confirm it. Conclusion: The analysis confirms that ranibizumab may be the most favorable for BCVA improvement and have a stronger efficacy in decreasing CMT and IOP than other drugs when taking all the indicators into consideration. This conclusion may provide clinical evidence to guide treatment decisions. However, more high-quality randomized controlled trials will be necessary to further confirm this. [ABSTRACT FROM AUTHOR]