Pharmacogenomics of antiVEGF in Patients With Age-Associated Macular Degeneration (AMD)

Parc de Salut Mar

Status and phase: Enrolling; Phase 3

Conditions: Wet Age-related Macular Degeneration

Treatments: Drug: Bevacizumab; Drug: Ranibizumab Ophthalmic

Study type: Interventional

Funder types: Other

Identifiers

NCT06952452

ICI21/00025

2019-003204-12 (EudraCT Number)

Details and patient eligibility

About

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)

Enrollment: 630 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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630 participants in 2 patient groups

Bevacizumab, BVZ (group A)

Experimental group

Description:

A cycle of 3 intravitreal injections every 4-6 weeks of BVZ

Treatment:

Drug: Bevacizumab

Ranibizumab, RBZ (group B)

Active Comparator group

Description:

A cycle of 3 intravitreal injections every 4-6 weeks of RBZ

Treatment:

Drug: Ranibizumab Ophthalmic