Age-Related Macular Degeneration (ARMD) Clinical Trials

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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
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• Patients diagnosed with neovascular Age-related Macular Degeneration

• Age of 50 years or older.

• That at the discretion of the ophthalmologist has an indication of receiving treatment with an anti-VEGF agent as usual in clinical practice.

• Without previous treatment in the eye under study (no previous treatment for AMD).

Locations
Other Locations
Spain
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital la Esperanza
RECRUITING
Barcelona
Unidad Central de Investigación Clínica y Ensayos Clínicos (UCICEC La Paz)
RECRUITING
Madrid
Hospital Universitario de Canarias
RECRUITING
San Cristóbal De La Laguna
Contact Information
Primary
Ana Aldea
aaldea@imim.es
+3431604900
Backup
Melina Rojas
mrojas@researchmar.net
Time Frame
Start Date: 2022-11-18
Estimated Completion Date: 2026-07
Participants
Target number of participants: 630
Treatments
Experimental: Bevacizumab, BVZ (group A)
A cycle of 3 intravitreal injections every 4-6 weeks of BVZ
Active_comparator: Ranibizumab, RBZ (group B)
A cycle of 3 intravitreal injections every 4-6 weeks of RBZ
Related Therapeutic Areas
Late-Onset Retinal Degeneration
Age-Related Macular Degeneration (ARMD)
Sponsors
Collaborators: Instituto de Salud Carlos III
Leads: Parc de Salut Mar

This content was sourced from clinicaltrials.gov

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