Comparison of Rapid Aflibercept and Brolucizumab T&E in wAMD

Sponsor
Berner Augenklinik
Study ID
NCT04932980
Status
Active Not Recruiting

Conditions

  • Wet Age-related Macular Degeneration

Eligibility Criteria

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

Interventions

  • Aflibercept — DRUG
    administration of anti-VEGF Aflibercept (Eylea)
  • Brolucizumab — DRUG
    administration of anti-VEGF Brolucizumab (Beovu)
  • early treat and extend (T&E) — PROCEDURE
    extension of treatment intervals (T\&E) from the beginning of treatment

Study Details

The currently widely established and preferred protocol for the treatment of wet age-related macular degeneration includes a loading phase of three monthly injections without interim adaptation or treatment according to disease activity, thereafter following a T\&E strategy with treatment adaptation in increments of 2-4 weeks according to disease activity. Based on pharmacological considerations regarding the vitreal half-life of the drugs, the aim of this prospective explorative study is to test whether an early extension of treatment intervals without a loading phase is an option without compromising functional outcomes. Based on a superiority of Afl compared to Ran with regard to achieving a dry retina after one year and based on studies, but in the absence of real-life experience with Bro, it seems of interest to test how far Afl and Bro are comparable in terms of their potential to extend the treatment intervals over 12 months, the time to dryness of the retina, and number of injections. Also, it is of high clinical relevance to demonstrate efficacy with longer initial treatment intervals compared to the current possibly over-treating loading-phase with three four-weekly injections.

Key Dates

Start date
May 9, 2022
Status verified
Nov 2025
Primary completion
Jun 30, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Aflibercept ® rapid treatment extension (T&E)
    Early treat and extend (T\&E) with Aflibercept ®. First IVT followed by control after 3 weeks and 2nd IVT after 6 weeks (= shortest treatment interval). Treatment will be adjusted according to morphologic response by adaptation of treatment intervals in +/- two-week increments.
  • Active Comparator: Brolucizumab ® rapid treatment extension (T&E)
    Early treat and extend (T\&E) with Brolucizumab ®. First IVT followed by control after 3 weeks and 2nd IVT after 6 weeks (= shortest treatment interval). Treatment will be adjusted according to morphologic response by adaptation of treatment intervals in +/- two-week increments.

Primary Outcome Measure

Number of injections given until week 52 [ Time Frame: 52 weeks ]

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