Pharmacogenomics of antiVEGF in Patients With Age-Associated Macular Degeneration (AMD)
NCT ID: NCT06952452
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
630 participants
INTERVENTIONAL
2022-11-18
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Bevacizumab, BVZ (group A)
A cycle of 3 intravitreal injections every 4-6 weeks of BVZ
Bevacizumab
The dosage for each intravitreal injection is 1.25mg of BVZ in 0.05ml
Ranibizumab, RBZ (group B)
A cycle of 3 intravitreal injections every 4-6 weeks of RBZ
Ranibizumab Ophthalmic
The dosage for each intravitreal injection contains 0.5mg of RBZ in 0.05ml
Interventions
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Bevacizumab
The dosage for each intravitreal injection is 1.25mg of BVZ in 0.05ml
Ranibizumab Ophthalmic
The dosage for each intravitreal injection contains 0.5mg of RBZ in 0.05ml
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
ALL
No
Sponsors
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Instituto de Salud Carlos III
OTHER_GOV
Parc de Salut Mar
OTHER
Responsible Party
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Locations
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Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital la Esperanza
Barcelona, , Spain
Unidad Central de Investigación Clínica y Ensayos Clínicos (UCICEC La Paz)
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Hugo Tapia
Role: primary
Jose Ignacio Vela
Role: primary
Alba Parrado
Role: primary
Alicia Marín Candón
Role: primary
Other Identifiers
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2019-003204-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ICI21/00025
Identifier Type: -
Identifier Source: org_study_id
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