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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003204-12 | EudraCT Number |
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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab, BVZ (group A) | Experimental | A cycle of 3 intravitreal injections every 4-6 weeks of BVZ |
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| Ranibizumab, RBZ (group B) | Active Comparator | A cycle of 3 intravitreal injections every 4-6 weeks of RBZ |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | The dosage for each intravitreal injection is 1.25mg of BVZ in 0.05ml |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | From baseline, first dose, up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana Aldea | Contact | +3431604900 | aaldea@imim.es | |
| Melina Rojas | Contact | mrojas@researchmar.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Canarias | Recruiting | San Cristóbal de La Laguna | Santa Cruz De Tenerife | Spain |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Participants will be randomized 1:1 into one of two treatment arms: ranibizumab or bevacizumab. Patients who meet elegibility criteria and decline participation due to treatment randomization, will participate in an observational follow-up.
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| Ranibizumab Ophthalmic | Drug | The dosage for each intravitreal injection contains 0.5mg of RBZ in 0.05ml |
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| Baseline, 6 months, 12 months, 24 months, 36 months |
| 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) | Baseline, 6 months, 12 months, 24 months, 36 months |
| 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. | At baseline |
| 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. | At baseline |
| Proportion of Smokers Among Patients With AMD Receiving Anti-VEGF Therapy | Proportion of participants with a history of tobacco use at baseline, categorized as current, former, or never smokers. Unit of Measure: % of participants by smoking status. Measurement Tool: Patient-reported history via questionnaire or clinical interview. | At baseline |
| Weight of Patients With AMD Receiving Anti-VEGF Therapy | Mean weight of participants measured at baseline. Weight will be used both as a descriptive baseline characteristic and as part of the BMI calculation. Unit of Measure: Kilograms (kg) Measurement Tool: Calibrated digital scale | At baseline |
| Height of Patients With AMD Receiving Anti-VEGF Therapy | Mean height of participants measured at baseline. Height will be used both as a descriptive baseline characteristic and as part of the BMI calculation. Unit of Measure: Meters (m) Measurement Tool: Stadiometer | At baseline |
| Prevalence of Obesity in Patients With AMD Receiving Anti-VEGF Therapy | Proportion of participants with obesity, defined as BMI ≥ 30 kg/m² at baseline. Unit of Measure: % of participants with BMI ≥ 30 kg/m². Measurement Tool: Body Mass Index (BMI) calculated from measured height and weight. | At baseline |
| Prevalence of Hypertension in Patients With AMD Receiving Anti-VEGF Therapy | Proportion of participants with a diagnosis of hypertension at baseline. Unit of Measure: % of participants with hypertension. Measurement Tool: Clinical diagnosis from patient medical records or blood pressure measurement (≥140/90 mmHg). | At baseline |
| Number of Participants With Ocular and Systemic Adverse Events Associated With Intravitreal Anti-VEGF Therapy | Total number of participants experiencing ocular or systemic adverse events, including cardiovascular events (e.g., myocardial infarction, stroke), following intravitreal injection of ranibizumab or bevacizumab. Events will be assessed cumulatively from the third intravitreal injection through the 3-year follow-up. Unit of Measure: Number of participants with at least one adverse event. Measurement Tool: Clinical assessment and adverse event reporting as per standard pharmacovigilance procedures. | From intravitreal injection, up to 3 years |
| Total Direct Healthcare Cost per Patient for Anti-VEGF Therapy Over One Year From the Health System Perspective | Total direct healthcare cost per patient treated with ranibizumab or bevacizumab over a 1-year period, based on a cost minimization analysis assuming similar clinical efficacy. Costs will be calculated from the perspective of the Spanish National Health System (SNS) and will include drug acquisition (considering container cost and fractionation), number of intravitreal injections, pharmacogenomic testing, and clinical monitoring. The NEI VFQ-25 composite score will be used to contextualize quality-of-life outcomes within the economic evaluation. Unit of Measure: Euros per patient. Measurement Tool: Cost minimization analysis based on administrative and billing records; NEI VFQ-25 (National Eye Institute Visual Function Questionnaire) for quality-of-life scoring. | From baseline up to 1 year |
| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | Spain |
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| Hospital la Esperanza | Recruiting | Barcelona | Spain |
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| Unidad Central de Investigación Clínica y Ensayos Clínicos (UCICEC La Paz) | Recruiting | Madrid | 28046 | Spain |
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |