drugset / Trial / NCT04698850

Brolucizumab vs. Aflibercept for Retinal Angiomatous Proliferation

NCT04698850

RandomizedParallel-groupSingle-blindTreatment

Summary

This is a prospective randomised study comparing two intravitreal antiVEGF drugs - brolucizumab and aflibercept - in the treatment of retinal angiomatous proliferation (RAP). Patients with RAP confirmed on optical coherence tomography (OCT) and on OCT angiography (OCTA) will be randomised in two groups and followed for 52 weeks. Patients in the first group will receive aflibercept - 3 injections monthly for the first 3 months and then in treat-and-extend regimen with minimal interval of 8 weeks and maximal interval of 16 weeks. Extension or shortening of the therapeutic interval will be possible in 2 or 4 week increments based on the visual acuity and disease activity assessed on OCT. Patients in the second group will receive brolucizumab - 3 injections monthly in the first 3 months and then every 2 or 3 months based on the visual acuity and disease activity assessed on OCT. Best corrected visual acuity (BCVA), central retinal thickness (CRT) on OCT and number of injections will be compared between both groups.

Timeline

Start
2021-01-04
Primary completion
2023-01
Completion
2023-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aflibercept Protein / enzyme biologic 40 mg/ml Intravitreal
Subject Brolucizumab Other / unclassified 120 mg/ml Intravitreal
Background Ranibizumab Monoclonal antibody 6 mg/ml