Status:
RECRUITING
Pharmacogenomics of antiVEGF in Patients With Age-Associated Macular Degeneration (AMD)
Lead Sponsor:
Parc de Salut Mar
Collaborating Sponsors:
Instituto de Salud Carlos III
Conditions:
Wet Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief 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 criter...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- Participate or have participated in another clinical trial with an experimental drug in the last 6 months.
- 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.
- Concomitant, ocular or systemic, administration of drugs up to 3 months before the treatment with another anti-VEGF in the contralateral eye.
- 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.
- Diabetic retinopathy documented.
- 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.
Key Trial Info
Start Date :
November 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
630 Patients enrolled
Trial Details
Trial ID
NCT06952452
Start Date
November 18 2022
End Date
July 1 2026
Last Update
November 20 2025
Active Locations (4)
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1
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
2
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
3
Hospital la Esperanza
Barcelona, Spain
4
Unidad Central de Investigación Clínica y Ensayos Clínicos (UCICEC La Paz)
Madrid, Spain, 28046