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RECRUITING
NCT06952452
PHASE3

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

Sponsor: Parc de Salut Mar

View on ClinicalTrials.gov

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)

Official title: 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.

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

630

Start Date

2022-11-18

Completion Date

2026-07

Last Updated

2025-11-20

Healthy Volunteers

No

Interventions

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

Locations (4)

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital la Esperanza

Barcelona, Spain

Unidad Central de Investigación Clínica y Ensayos Clínicos (UCICEC La Paz)

Madrid, Spain