Wet Age-related Macular DegenerationPhase 3AMDNCT06952452
Pharmacogenomics of antiVEGF in Patients With Age-Associated Macular Degeneration (AMD)
A Phase 3 study testing Bevacizumab and Ranibizumab Ophthalmic in people with Wet Age-related Macular Degeneration, run by Parc de Salut Mar at 4 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Wet Age-related Macular Degeneration
- What is being tested?
- Bevacizumab and Ranibizumab Ophthalmic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- 4 sitesSpain
- Study dates
- 18 Nov 2022to Jul 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Melina Rojas contact
Spain4 sites, 4 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona
Jose Ignacio Vela
Melina Rojas, mrojas@researchmar.net
- Recruiting
Hospital la Esperanza
Barcelona
Alba Parrado
Melina Rojas, mrojas@researchmar.net
- Recruiting
Unidad Central de Investigación Clínica y Ensayos Clínicos (UCICEC La Paz)
Madrid, 28046
Alicia Marín Candón
Melina Rojas, mrojas@researchmar.net
- Recruiting
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife
Hugo Tapia
Melina Rojas, mrojas@researchmar.net
About this study
Official 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.
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)
- Conditions
- Wet Age-related Macular Degeneration
- Being tested
- Bevacizumab, Ranibizumab Ophthalmic
- Keywords
- wAMD, antiVEGF, BVZ, RBZ, AMD, pharmacogenomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin, L01XC07
The dosage for each intravitreal injection is 1.25mg of BVZ in 0.05ml
Ranibizumab OphthalmicDrug
Also called Lucentis, S01LA04
The dosage for each intravitreal injection contains 0.5mg of RBZ in 0.05ml
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab, BVZ (group A) | Experimental | A cycle of 3 intravitreal injections every 4-6 weeks of BVZ Receives: Drug: Bevacizumab |
| Ranibizumab, RBZ (group B) | Active comparator | A cycle of 3 intravitreal injections every 4-6 weeks of RBZ Receives: Drug: Ranibizumab Ophthalmic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From baseline, first dose, up to 3 years
Secondary outcomes (11)
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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: From baseline up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start18 Nov 2022
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952452
- Sponsor's protocol ID
- ICI21/00025
- Other IDs
- 2019-003204-12, 2019
- Acronym
- AMD
- Status last verified
- Nov 2025
- First submitted
- 28 Oct 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06952452
- Acronym / sponsor ID
- AMD / ICI21/00025
- Conditions
- Wet Age-related Macular Degeneration
- Keywords
- wAMD, antiVEGF, BVZ, RBZ, AMD, pharmacogenomics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 630 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab, BVZ (group A) | Experimental | Drug: BevacizumabA cycle of 3 intravitreal injections every 4-6 weeks of BVZ |
| Ranibizumab, RBZ (group B) | Active comparator | Drug: Ranibizumab OphthalmicA cycle of 3 intravitreal injections every 4-6 weeks of RBZ |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: Avastin, L01XC07The dosage for each intravitreal injection is 1.25mg of BVZ in 0.05ml | Drug | Bevacizumab, BVZ (group A) |
| Ranibizumab OphthalmicAlso: Lucentis, S01LA04The dosage for each intravitreal injection contains 0.5mg of RBZ in 0.05ml | Drug | Ranibizumab, RBZ (group B) |
Primary outcome
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).
11 secondary outcomes
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
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
Distribution of Sex Among Patients With AMD Receiving Anti-VEGF Therapy
Time frame: At baseline
Distribution of Age at Diagnosis in Patients With AMD Receiving Anti-VEGF Therapy
Time frame: At baseline
Proportion of Smokers Among Patients With AMD Receiving Anti-VEGF Therapy
Time frame: At baseline
Weight of Patients With AMD Receiving Anti-VEGF Therapy
Time frame: At baseline
Height of Patients With AMD Receiving Anti-VEGF Therapy
Time frame: At baseline
Prevalence of Obesity in Patients With AMD Receiving Anti-VEGF Therapy
Time frame: At baseline
Prevalence of Hypertension in Patients With AMD Receiving Anti-VEGF Therapy
Time frame: At baseline
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 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melina Rojas contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bevacizumab and Ranibizumab Ophthalmic in people with Wet Age-related Macular Degeneration, run by Parc de Salut Mar at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Aldea (+3431604900, aaldea@imim.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.