Comparing two treatments for wet age-related macular degeneration
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.
This study is testing which of two eye treatments, ranibizumab or bevacizumab, works better for people with wet age-related macular degeneration.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 630 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Parc de Salut Mar Academic / other |
| Drugs / interventions | ranibizumab, bevacizumab |
| Locations | 4 sites (San Cristóbal de La Laguna, Santa Cruz De Tenerife and 3 other locations) |
| Trial ID | NCT06952452 on ClinicalTrials.gov |
What this trial studies
This phase III clinical trial investigates the effectiveness of two anti-VEGF treatments, ranibizumab and bevacizumab, in patients diagnosed with wet age-related macular degeneration (wAMD). The study involves 630 eyes and is designed as a multicenter, randomized, double-blinded trial with two parallel groups. Patients will be monitored over a three-year period to assess their treatment response, while also considering genetic variants that may influence outcomes. An observational follow-up will be conducted for patients who meet eligibility criteria but choose not to participate in the treatment randomization.
Who should consider this trial
Good fit: Ideal candidates are patients aged 50 years or older diagnosed with neovascular age-related macular degeneration who have not received previous treatment in the eye under study.
Not a fit: Patients with other eye diseases or those who have participated in another clinical trial with an experimental drug in the last 6 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment for wAMD, potentially improving patient outcomes and treatment strategies.
How similar studies have performed: Other studies have shown success with similar anti-VEGF treatments, indicating that this approach is well-established in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
San Cristóbal de La Laguna, Santa Cruz De Tenerife and 3 other locations
- Hospital Universitario de Canarias — San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain (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)
Study contacts
- Study coordinator: Ana Aldea
- Email: aaldea@imim.es
- Phone: +3431604900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.