Pharmacogenomics of antiVEGF in Patients With Age-Associated Macular Degeneration (AMD)
Condition(s) studied
Investigational drug(s) / intervention(s)
Bevacizumab: The dosage for each intravitreal injection is 1.25mg of BVZ in 0.05ml
Ranibizumab Ophthalmic: The dosage for each intravitreal injection contains 0.5mg of RBZ in 0.05ml
Study 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
Primary outcome measure(s)
- Frequency of Genetic Polymorphism in VEGFA Associated With Anti-VEGF Treatment Response in AMD Patients — From baseline, first dose, up to 3 years
Proportion of patients carrying the VEGFA genetic polymorphism (VEGFA, CFH, CTFG, ARMS2, HTRA1, OR52B4, LOC387715, LOC100287225, LEPR, SERPINF1), as determined by genotyping of DNA extracted from saliva samples. This measure will be correlated with response to anti-VEGF therapy (ranibizumab or aflibercept). Unit of Measure: % of participants with polymorphism. Measurement Tool: Genotyping assay on saliva-derived DNA (e.g., TaqMan PCR-based method).
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Hospital Universitario de Canarias | San Cristóbal de La Laguna | Santa Cruz De Tenerife | Recruiting |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | Recruiting |
| Hospital la Esperanza | Barcelona | Spain | Recruiting |
| Unidad Central de Investigación Clínica y Ensayos Clínicos (UCICEC La Paz) | Madrid | Spain | Recruiting |
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06952452 on ClinicalTrials.gov ↗ ← All trials in Spain