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)
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).
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.
Parallel
Bevacizumab
DrugThe dosage for each intravitreal injection is 1.25mg of BVZ in 0.05ml
Ranibizumab Ophthalmic
DrugThe dosage for each intravitreal injection contains 0.5mg of RBZ in 0.05ml
Frequency of Genetic Polymorphism in VEGFA Associated With Anti-VEGF Treatment Response in AMD Patients
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).
Change in Visual Acuity Over Time in Patients With AMD Receiving Anti-VEGF Therapy
Visual acuity (VA), measured in number of letters read on the ETDRS chart, at baseline and at months 6, 12, 24, and 36. The change from baseline will be analyzed to assess treatment response over time. Unit of Measure: Number of letters (ETDRS scale). Measurement Tool: ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity chart.
Change in Retinal Fluid and Foveal Thickness Over Time as Measured by OCT in Patients With AMD Treated With Anti-VEGF Therapy
Retinal anatomical changes assessed by OCT, including presence and amount of intraretinal and/or subretinal fluid, and central foveal thickness (in microns), measured at baseline and at months 6, 12, 24, and 36. Differences between treatment arms (ranibizumab vs. bevacizumab) will be evaluated over time. Unit of Measure: Microns for foveal thickness; qualitative presence/absence or categorical grading of retinal fluid Measurement Tool: Spectral-domain Optical Coherence Tomography (SD-OCT)
Distribution of Sex Among Patients With AMD Receiving Anti-VEGF Therapy
Proportion of male and female participants in the study population, analyzed in relation to treatment response to anti-VEGF drugs. Unit of Measure: % of participants by sex. Measurement Tool: Demographic data collected via clinical records.
Distribution of Age at Diagnosis in Patients With AMD Receiving Anti-VEGF Therapy
Age in years at time of AMD diagnosis for each participant. Age will be analyzed as a continuous variable in relation to treatment response. Unit of Measure: Years. Measurement Tool: patient-reported age or medical record.
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Parc de Salut Mar
Lead sponsor
Instituto de Salud Carlos III
Collaborator
