Multicentre, Randomised, Double-blind, Parallel-group, Phase III Study to Evaluate Genetic Polymorphism Influence on Ranibizumab and Bevacizumab Treatment Response in Age-Associated Macular Degeneration

What this Trial Is About

Researchers are studying patients diagnosed with wet age-related macular degeneration (wAMD) to compare how genetic differences affect responses to two anti-VEGF treatments: ranibizumab and bevacizumab. This phase III, multicenter, randomized, double-blind trial aims to evaluate the treatment responses over three years in 630 eyes affected by wAMD without other eye diseases. The study focuses on understanding the influence of genetic polymorphisms on treatment outcomes with these commonly used anti-VEGF drugs. Participants receive either bevacizumab or ranibizumab through cycles of three intravitreal injections spaced every 4 to 6 weeks. Bevacizumab is given at a dose of 1.25 mg in 0.05 ml, while ranibizumab is given at 0.5 mg in 0.05 ml. Patients who meet eligibility but choose not to participate in the randomized treatment will be followed observationally, with genetic saliva samples collected and clinical data recorded for up to three years. Throughout the study, participants undergo regular assessments including visual acuity checks, retinal fluid and foveal thickness measurements by OCT, and monitoring for eye and systemic side effects. Data on demographics, smoking status, weight, height, obesity, and hypertension are also collected at baseline. The primary outcome measures the frequency of a genetic polymorphism in VEGFA related to anti-VEGF response over three years. Safety, visual function, and health care costs are tracked throughout the study period.

Pharmacogenomics of antiVEGF in Patients With Age-Associated Macular Degeneration (AMD)