NCT06952452RecruitingPhase 3
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.
Source: ClinicalTrials.gov · Last updated 20 Nov 2025
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 630 (estimated)
- First submitted
- 28 Oct 2024
- Start date
- 18 Nov 2022
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- Parc de Salut Mar
- Diseases
- Macular degeneration
- NCT number
- NCT06952452
- EU CT number
- 2024-518990-33-00
- EudraCT number
- 2019-003204-12
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 630
- From 18 Nov 2022 to the primary completion date, 31 Jul 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participate or have participated in another clinical trial with an experimental drug in the last 6 months.
- Concomitant, ocular or systemic, administration of drugs up to 3 months before the treatment with another anti-VEGF in the contralateral eye.
- Pregnant or nursing (lactating) women.
- Patients who meet elegibility criteria and decline participation due to treatment randomization, will participate in an observational follow-up, collecting saliva for the analysis of genetic polymorphisms and clinical data related to antiVEGF received out of the clinical trial and AV, OCT results and adverse events registered in medical records at 6m, 12m, 24m, 36m.
Other illness
- Patients with other eye diseases, p. eg, advanced glaucoma or visually significant cataracts, which are likely to require surgery during the follow-up period in the eye under study.
- High cardiovascular risk: poorly controlled arterial hypertension, history or risk of arterial thromboembolic events, history of stroke or acute myocardial infarction, anticoagulant treatment, proteinuria or major elective surgery within 3 months.
- Ophthalmological risk with the intraocular injection (all intravitreal treatments): active or suspected ocular or periocular infection, severe blepharitis, history of endophthalmitis, history of retinal detachment, myopathy, glaucoma.
- Hypersensitivity to the active substance or to the excipients.
Other
- Diabetic retinopathy documented.
Who the study is looking for
- 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).
Age in the registry: 50 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| La Paz Univerity Hospital Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario de Canarias Coordinator of this site? Confirm its status | San Cristóbal de La Laguna | Spain | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.