Clinical trial NCT06952452: Pharmacogenomics of antiVEGF in Patients With Age-Associated Macular Degeneration (AMD)
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Wet Age-related Macular Degeneration
Keywords: wAMD
antiVEGF
BVZ
RBZ
AMD
pharmacogenomics
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2025-04-30
Enrollment: 630
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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)


Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of Genetic Polymorphism in VEGFA Associated With Anti-VEGF Treatment Response in AMD Patients
timeFrame: From baseline, first dose, up to 3 years
Secondary outcomes:
measure: Change in Visual Acuity Over Time in Patients With AMD Receiving Anti-VEGF Therapy
timeFrame: Baseline, 6 months, 12 months, 24 months, 36 months
measure: Change in Retinal Fluid and Foveal Thickness Over Time as Measured by OCT in Patients With AMD Treated With Anti-VEGF Therapy
timeFrame: Baseline, 6 months, 12 months, 24 months, 36 months
measure: Distribution of Sex Among Patients With AMD Receiving Anti-VEGF Therapy
timeFrame: At baseline
measure: Distribution of Age at Diagnosis in Patients With AMD Receiving Anti-VEGF Therapy
timeFrame: At baseline
measure: Proportion of Smokers Among Patients With AMD Receiving Anti-VEGF Therapy
timeFrame: At baseline
measure: Weight of Patients With AMD Receiving Anti-VEGF Therapy
timeFrame: At baseline
measure: Height of Patients With AMD Receiving Anti-VEGF Therapy
timeFrame: At baseline
measure: Prevalence of Obesity in Patients With AMD Receiving Anti-VEGF Therapy
timeFrame: At baseline
measure: Prevalence of Hypertension in Patients With AMD Receiving Anti-VEGF Therapy
timeFrame: At baseline
measure: Number of Participants With Ocular and Systemic Adverse Events Associated With Intravitreal Anti-VEGF Therapy
timeFrame: From intravitreal injection, up to 3 years
measure: Total Direct Healthcare Cost per Patient for Anti-VEGF Therapy Over One Year From the Health System Perspective
timeFrame: From baseline up to 1 year
Other outcomes:
Locations:
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Santa Cruz De Tenerife
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital la Esperanza
Study officials:
References: