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

Sponsor
Parc de Salut Mar
Study ID
NCT06952452
Phase
PHASE3
Status
Recruiting
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Conditions

  • Wet Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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)

Key Dates

First listed
Apr 30, 2025
Start date
Nov 18, 2022
Status verified
Nov 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
630 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Frequency of Genetic Polymorphism in VEGFA Associated With Anti-VEGF Treatment Response in AMD Patients [ Time Frame: From baseline, first dose, up to 3 years ]

Central Contacts

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