2 Prior pivotal trials of anti-VEGF agents given at fixed monthly dosing intervals in nAMD have consistently achieved approximately 8 to 9 letters of improvement in visual acuity over the first year. 1, 2 Anti–vascular endothelial growth factor (anti-VEGF) therapies represent standard care for neovascular AMD (nAMD), which accounts for approximately 90% of severe vision loss due to AMD.
#Florida retina institute ophthalmology registration
Trial Registration Identifier: NCT04126317Īge-related macular degeneration (AMD) is a leading cause of vision impairment and blindness, estimated to affect 288 million individuals globally by 2040. These findings support further evaluation of aflibercept, 8 mg, in pivotal trials of exudative retinal diseases including nAMD and diabetic macular edema. No new safety signals were observed over 44 weeks.
No differences in safety profiles between the groups were observed.Ĭonclusions and Relevance Although aflibercept, 8 mg, did not achieve the primary efficacy end point at week 16 at the 2-sided significance level of 5%, the observed trends in anatomic and visual improvements over 44 weeks with aflibercept, 8 mg, indicate potential additional therapeutic benefit over aflibercept, 2 mg. At week 44, mean (SE) change in central retinal thickness was –159.4 (16.4) vs –137.2 (22.8) μm with 8 mg vs 2 mg of aflibercept, respectively (least squares mean difference, –9.5 nominal P = .65) and mean (SE) change in best-corrected visual acuity score was +7.9 (1.5) vs +5.1 (1.5) letters (least squares mean difference, +2.8 nominal P = .20). The proportion of eyes without fluid in the central subfield with 8-mg vs 2-mg aflibercept was 50.9% (n = 27) vs 34.0% (n = 18) (difference, 17.0 percentage points P = .08) at week 16 and 39.6% (n = 21) vs 28.3% (n = 15) (difference, 11.3 percentage points nominal P = .22) at week 44. Overall, 66 participants (62.3%) were female. Results All 106 eligible eyes were randomized to receive aflibercept, 8 mg (n = 53), or aflibercept, 2 mg (n = 53). Main Outcomes and Measures Coprimary end points were the proportion of eyes without fluid (absence of intraretinal and subretinal fluid) in the central subfield at week 16 and safety. Interventions Eligible participants were randomized 1:1 to receive 3 monthly doses of 8 mg (70 μL) or 2 mg (50 μL) of aflibercept followed by doses at weeks 20 and 32. Treatment-naive patients with active subfoveal choroidal neovascularization secondary to nAMD and a best-corrected visual acuity score of 78 to 24 letters (approximately 20/32 to 20/320) in the study eye were enrolled between November 2019 and November 2021. Objective To assess safety and efficacy of aflibercept, 8 mg, in patients with nAMD.ĭesign, Setting, and Participants The CANDELA trial was a phase 2, randomized, single-masked, open-label, 44-week clinical trial conducted in the US. Importance Aflibercept, 8 mg, may have greater therapeutic benefits compared with aflibercept, 2 mg, in patients with neovascular age-related macular degeneration (nAMD), including potentially improved outcomes and decreased treatment burden. Shared Decision Making and Communication.Scientific Discovery and the Future of Medicine.Health Care Economics, Insurance, Payment.Clinical Implications of Basic Neuroscience.Challenges in Clinical Electrocardiography.
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