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Purpose: Complications associated with intravitreal anti-VEGF therapies are reported inconsistently in the literature, thus limiting an accurate evaluation and comparison of safety between studies. This study aimed to develop a standardized classification system for anti-VEGF ocular complications using the Delphi consensus process., Design: Systematic review and Delphi consensus process., Participants: Twenty-five international retinal specialists participated in the Delphi consensus survey., Methods: A systematic literature search was conducted to identify complications of intravitreal anti-VEGF agent administration based on randomized controlled trials (RCTs) of anti-VEGF therapy. A comprehensive list of complications was derived from these studies, and this list was subjected to iterative Delphi consensus surveys involving international retinal specialists who voted on inclusion, exclusion, rephrasing, and addition of complications. Furthermore, surveys determined specifiers for the selected complications. This iterative process helped to refine the final classification system., Main Outcome Measures: The proportion of retinal specialists who choose to include or exclude complications associated with anti-VEGF administration., Results: After screening 18 229 articles, 130 complications were categorized from 145 included RCTs. Participant consensus via the Delphi method resulted in the inclusion of 91 complications (70%) after 3 rounds. After incorporating further modifications made based on participant suggestions, such as rewording certain phrases and combining similar terms, 24 redundant complications were removed, leaving a total of 67 complications (52%) in the final list. A total of 14 complications (11%) met exclusion thresholds and were eliminated by participants across both rounds. All other remaining complications not meeting inclusion or exclusion thresholds also were excluded from the final classification system after the Delphi process terminated. In addition, 47 of 75 proposed complication specifiers (63%) were included based on participant agreement., Conclusions: Using the Delphi consensus process, a comprehensive, standardized classification system consisting of 67 ocular complications and 47 unique specifiers was established for intravitreal anti-VEGF agents in clinical trials. The adoption of this system in future trials could improve consistency and quality of adverse event reporting, potentially facilitating more accurate risk-benefit analyses., Financial Disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article., (Copyright © 2024 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Purpose: To compare early anatomic outcomes following treatment with faricimab vs. aflibercept in a pooled analysis of the head-to-head dosing phase of the TENAYA/LUCERNE trials in neovascular age-related macular degeneration (nAMD)., Design: TENAYA/LUCERNE (NCT03823287/NCT03823300) were identical, randomized, double-masked, active comparator-controlled phase 3 noninferiority trials., Participants: Aged ≥ 50 years with treatment-naïve nAMD., Methods: Patients were randomized (1:1) to intravitreal faricimab 6.0 mg up to every 16 weeks (Q16W) after 4 initial doses every 4 weeks (Q4W) or aflibercept 2.0 mg every 8 weeks (Q8W) after 3 initial doses given Q4W., Main Outcome Measures: Post hoc analyses comparing faricimab with aflibercept in terms of change in central subfield thickness (CST) from baseline and proportion of patients with an absence of subretinal (SRF) and intraretinal fluid (IRF) during initial 12-week head-to-head dosing phase, when both arms received 3 injections, and time to first absence of IRF and SRF., Results: 1329 patients were enrolled across TENAYA/LUCERNE (n = 665 faricimab; n = 664 aflibercept). There were greater (nominal P < 0.0001) reductions in adjusted mean CST from baseline with faricimab vs. aflibercept at weeks 4, 8, and 12, with comparable vision outcomes. At week 12, more patients (95% confidence interval) achieved an absence of SRF (87.9% [85.4%, 90.4%] vs. 79.0% [76.0%, 82.1%]) and both IRF and SRF (77.2% [74.0%, 80.4%] vs. 66.5% [62.9%, 70.0%]), but not IRF (88.4% [86.0%, 90.8%] vs. 85.0% [82.3%, 87.6%]), with faricimab vs. aflibercept, respectively. In patients with IRF and/or SRF at baseline (n = 581 faricimab; n = 591 aflibercept), the 75th percentile of time to first absence of IRF and SRF was reached at week 8 with faricimab and week 12 with aflibercept. At week 12, cumulative incidence of first-time absence of IRF and SRF was 85.5% (82.3%, 88.1%) with faricimab and 75.0% (71.3%, 78.3%) with aflibercept., Conclusions: Faricimab resulted in greater improvement in anatomic outcomes than aflibercept during the head-to-head dosing phase and a faster time to first absence of retinal fluid., (Copyright © 2024. Published by Elsevier Inc.)

Purpose: Although there have been many population-based studies of age-related macular degeneration (AMD), only limited information is available in Asia on the epidemiology of geographic atrophy (GA). We aimed to determine the prevalence and patterns of GA through an analysis of multiple studies conducted within the Asian Eye Epidemiology Consortium (AEEC)., Design: Cross-sectional meta-analyses., Participants: A total of 97 213 individuals aged 40 years and older., Methods: Data from 22 population-based studies from countries belonging to the AEEC were included. In all studies, AMD was defined on the basis of standardized grading systems. Geographic atrophy was defined as an area of pallor in the fundus with visibility of the underlying choroidal blood vessels and sharply defined borders. Random-effects meta-analysis was performed to estimate overall and age-, gender-, and region-specific pooled prevalence of GA., Main Outcome Measures: Prevalence of GA per 1000 persons., Results: The mean age was 60.8 ± 10.0 years, and 42 673 (43.9%) were male. Overall, a total of 223 individuals (0.2%) had GA. The pooled overall prevalence of GA was 1.57 per 1000 persons (95% confidence interval [CI], 1.04-2.10), which was 3 times less than that of neovascular AMD of 5.20 per 1000 persons (95% CI, 3.97-6.43). Compared with those aged 50 to 59 years, the prevalence of GA increased from 0.34 per 1000 persons (95% CI, 0.07-0.62) to 2.90 per 1000 persons (95% CI, 1.55-4.25) in those aged ≥70 years. The GA prevalence per 1000 persons was similar between urban (2.22; 95% CI, 1.22-3.23) and rural residents (1.33; 95% CI, 0.70-1.96). Geographic atrophy was more prevalent in South Asia (based on studies from India and Nepal, 3.82 per 1000 persons; 95% CI, 1.72-5.93) compared with East Asia (based on studies from China, Korea, Hong Kong, Taiwan, and Japan, and the Singapore Chinese Eye Study, 0.76 per 1000 persons; 95% CI, 0.31-1.22, P = 0.005)., Conclusions: Geographic atrophy is uncommon in Asian populations compared with those of European ancestry. Even within Asia, geographic differences in GA prevalence were seen. The findings of this meta-analysis suggest that better dissection of risk factors in the Asian population for GA may provide insights into the biological pathways that drive these late-stage manifestations, thus suggesting better targets for prevention., (Copyright © 2020 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)