NCT04698850: BEY-RAP

Brolucizumab vs. Aflibercept for Retinal Angiomatous Proliferation - Prospective Randomised Study

Withdrawn Phase 4 Last updated 7 August 2022

What this trial tests

Phase 4 trial testing Aflibercept 40 MG/ML [Eylea] in Wet Macular Degeneration. Withdrawn.

Timeline

4 January 2021

Primary endpoint
1 January 2023

1 June 2023

Quick facts

Lead sponsor	Faculty Hospital Kralovske Vinohrady
Phase	Phase 4
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Start date	4 January 2021
Primary completion	1 January 2023
Estimated completion	1 June 2023
Sites	1 location across Czechia

Drugs / interventions tested

• Aflibercept 40 MG/ML [Eylea] — full drug profile →
• Brolucizumab-Dbll 120 MG/ML [Beovu] — full drug profile →
• Ranibizumab 6 MG/ML [Lucentis] — full drug profile →

Conditions studied

• Wet Macular Degeneration — all drugs for Wet Macular Degeneration →

Sponsor

Faculty Hospital Kralovske Vinohrady

Who can join

50 and older, any sex, with Wet Macular Degeneration. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Best corrected visual acuity
  Time frame: Baseline and week 52
  BCVA change from baseline to week 52.
• Central retinal thickness
  Time frame: Baseline and week 52
  CRT change from baseline to week 52.
• Number of injections
  Time frame: Week 52
  Average number of injections per patient in each group.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.