MedTrace Logo

Brolucizumab vs. Aflibercept for Retinal Angiomatous Proliferation

NCT04698850 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2022-08-10

No results posted yet for this study

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.

Conditions

  • Wet Macular Degeneration

Interventions

DRUG

Aflibercept 40 MG/ML [Eylea]

Patients will be receiving intravitreal aflibercept starting with 3 monthly doses and continuing with treat-and-extend regimen with minimal interval of 8 week and maximum interval of 16 week. Interval can be prolonged or shortened by 2 or 4 weeks based on the disease activity and BCVA..

DRUG

Brolucizumab-Dbll 120 MG/ML [Beovu]

Patients will be receiving intravitreal brolucizumab starting with 3 monthly doses followed by the treatment interval of 8 or 12 weeks based on the disease activity and BCVA.

DRUG

Ranibizumab 6 MG/ML [Lucentis]

Rescue therapy for patients with study drug related adverse events or with worsening of BCVA and OCT finding even on the shortest treatment interval when resistance to study drug is suspected.

Sponsors & Collaborators

  • Faculty Hospital Kralovske Vinohrady

    lead OTHER_GOV

Principal Investigators

  • Martin Pencak, M.D. · Faculty Hospital Kralovske Vinohrady

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-04
Primary Completion
2023-01-31
Completion
2023-06-30

Countries

  • Czechia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04698850 on ClinicalTrials.gov