Treatment of Recalcitrant Neovascular AMD Using Brolocizumab With Immediate T&E

Sponsor
The University of Hong Kong
Study ID
NCT05710471
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Brolucizumab — DRUG
    Intravitreal injection
  • Aflibercept — DRUG
    Intravitreal injection

Study Details

The investigator propose to conduct a randomized clinical trial, investigating the safety and efficacy of brolucizumab for treatment of nAMD patients with CNV, and plans to specifically target those who are not responding to standard Treat and Extend (T\&E) treatment. A randomised omized study will be conducted with 2 arms, one with the new drug (brolocizumab) and novel treatment protocol versus a second arm using the current gold standard of aflibercept and the T\&E protocol

Key Dates

Start date
Jul 25, 2022
Status verified
May 2024
Primary completion
Jul 25, 2023
Completion
Aug 30, 2023

Study Design

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

Arms

  • Experimental: Brolucizumab
    new drug (brolocizumab) and novel treatment protocol
  • Active Comparator: Aflibercept
    aflibercept and continuing on the traditional T\&E protocol. There will also be a rescue option for those in the aflibercept arm who are not responding well to also switch to brolocizumab

Primary Outcome Measure

Central Macular thickness [ Time Frame: 1 year ]

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