Brolucizumab vs. Aflibercept for Retinal Angiomatous Proliferation

Sponsor
Faculty Hospital Kralovske Vinohrady
Study ID
NCT04698850
Phase
PHASE4
Status
Withdrawn

Conditions

  • Wet Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aflibercept 40 MG/ML [Eylea] — DRUG
    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..
  • Brolucizumab-Dbll 120 MG/ML [Beovu] — DRUG
    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.
  • Ranibizumab 6 MG/ML [Lucentis] — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 4, 2021
Status verified
Aug 2022
Primary completion
Jan 31, 2023
Completion
Jun 30, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: aflibercept
    Patients with RAP who will be receiving aflibercept.
  • Experimental: brolucizumab
    Patients with RAP who will be receiving brolucizumab.

Primary Outcome Measure

Best corrected visual acuity [ Time Frame: Baseline and week 52 ]

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