Actively Recruiting
Pharmacogenomics of antiVEGF in Patients With Age-Associated Macular Degeneration (AMD)
Led by Parc de Salut Mar · Updated on 2025-11-20
630
Participants Needed
4
Research Sites
188 weeks
Total Duration
On this page
Sponsors
P
Parc de Salut Mar
Lead Sponsor
I
Instituto de Salud Carlos III
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Pharmacogenomics of antiVEGF in Patients With Age-Associated Macular Degeneration (AMD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with neovascular Age-related Macular Degeneration
- Age of 50 years or older
- Indicated by an ophthalmologist to receive anti-VEGF treatment as usual practice
- No previous treatment for AMD in the eye under study
You will not qualify if you...
- Participation in another clinical trial with an experimental drug within the last 6 months
- Presence of other eye diseases such as advanced glaucoma or visually significant cataracts likely requiring surgery during follow-up
- Use of ocular or systemic drugs within 3 months before treatment with another anti-VEGF in the other eye
- High cardiovascular risk including poorly controlled hypertension, history or risk of thromboembolic events, stroke, acute myocardial infarction, anticoagulant treatment, proteinuria, or major elective surgery within 3 months
- Risks related to intraocular injection such as active or suspected ocular/periocular infection, severe blepharitis, history of endophthalmitis, retinal detachment, myopathy, or glaucoma
- Hypersensitivity to the active substances or excipients
- Documented diabetic retinopathy
- Pregnant or nursing (lactating) women
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Actively Recruiting
2
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Actively Recruiting
3
Hospital la Esperanza
Barcelona, Spain
Actively Recruiting
4
Unidad Central de Investigación Clínica y Ensayos Clínicos (UCICEC La Paz)
Madrid, Spain, 28046
Actively Recruiting
Research Team
A
Ana Aldea
CONTACT
M
Melina Rojas
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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