Pharmacogenomics of antiVEGF in Patients With Age-Associated Macular Degeneration (AMD)
Wet Age-related Macular Degeneration
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 3
- Age range
- 50 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 172 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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)
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Quadruple masked
Bevacizumab, BVZ (group A)
A cycle of 3 intravitreal injections every 4-6 weeks of BVZ
Drug: Bevacizumab
Ranibizumab, RBZ (group B)
A cycle of 3 intravitreal injections every 4-6 weeks of RBZ
Drug: Ranibizumab Ophthalmic
Bevacizumab DRUG
The dosage for each intravitreal injection is 1.25mg of BVZ in 0.05ml
Ranibizumab Ophthalmic DRUG
The dosage for each intravitreal injection contains 0.5mg of RBZ in 0.05ml
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Frequency of Genetic Polymorphism in VEGFA Associated With Anti-VEGF Treatment Response in AMD Patients
Time frame: 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).
Secondary measures
Change in Visual Acuity Over Time in Patients With AMD Receiving Anti-VEGF Therapy
Time frame: Baseline, 6 months, 12 months, 24 months, 36 months
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
Time frame: Baseline, 6 months, 12 months, 24 months, 36 months
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
Time frame: At baseline
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
Time frame: At baseline
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.
Proportion of Smokers Among Patients With AMD Receiving Anti-VEGF Therapy
Time frame: At baseline
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.
Weight of Patients With AMD Receiving Anti-VEGF Therapy
Time frame: At baseline
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
Height of Patients With AMD Receiving Anti-VEGF Therapy
Time frame: At baseline
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
Prevalence of Obesity in Patients With AMD Receiving Anti-VEGF Therapy
Time frame: At baseline
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.
Prevalence of Hypertension in Patients With AMD Receiving Anti-VEGF Therapy
Time frame: At baseline
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).
Number of Participants With Ocular and Systemic Adverse Events Associated With Intravitreal Anti-VEGF Therapy
Time frame: From intravitreal injection, up to 3 years
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.
Total Direct Healthcare Cost per Patient for Anti-VEGF Therapy Over One Year From the Health System Perspective
Time frame: From baseline up to 1 year
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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (4)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
4 locations
Hospital Universitario de CanariasSan Cristóbal de La Laguna, Santa Cruz De Tenerife, SpainStatus unknown
Hospital de la Santa Creu i Sant PauBarcelona, SpainStatus unknown
Hospital la EsperanzaBarcelona, SpainStatus unknown
Unidad Central de Investigación Clínica y Ensayos Clínicos (UCICEC La Paz)Madrid, SpainStatus unknown
Study team and timeline
- Lead sponsor
- Parc de Salut Mar
- Study start
- Nov 18, 2022 Actual
- Primary completion
- May 28, 2026 Actual
- Study completion
- May 28, 2026 Actual
- First posted
- Apr 30, 2025 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
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.
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026