RecruitingPhase 3NCT06952452

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.


Sponsor

Parc de Salut Mar

Enrollment

630 participants

Start Date

Nov 18, 2022

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bevacizumab and a drug called Ranibizumab Ophthalmic for people with wet age related macular degeneration. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 50 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBevacizumab

The dosage for each intravitreal injection is 1.25mg of BVZ in 0.05ml

DRUGRanibizumab 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

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NCT06952452


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