NCT06952452

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 630 (estimated)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III, multicenter, randomized double-blinded clinical trial with two parallel groups (ranibizumab and bevacizumab) and an observational follow-up of patients who meet elegibility criteria and decline participation due to treatment randomization. It will be performed involving 630 eyes from patients with wet age-related macular degeneration (wAMD) diagnosis without another eye disease. This clinical trial compares the treatment response for 3 years, considering genetic variants already studied between the eyes treated with one of the first options of anti-VEGF used in patients with wAMD, (ranibizumab) and the most cost-effective anti-VEGF (bevacizumab; off-label use)

Conditions

• Wet Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Bevacizumab	The dosage for each intravitreal injection is 1.25mg of BVZ in 0.05ml
DRUG	Ranibizumab Ophthalmic	The dosage for each intravitreal injection contains 0.5mg of RBZ in 0.05ml

Timeline

• Start date: 2022-11-18
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-04-30
• Last updated: 2025-11-20

Locations

4 sites across 1 country: Spain