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

Sponsor
The University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT05710471
Collaborator
(none)
64
Enrollment
1
Location
2
Arms
13.2
Anticipated Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

In addition, there will also be a rescue option for those in the aflibercept arm who are not responding well to also switch to brolucizumab. The primary outcome is the change in central macular thickness, since we expect the new treatment to be effective in reducing intraretinal and subretinal fluids, which in effect are indicators of disease activity. In addition, investigator will look at the improvement of visual acuity, the reduction of treatment intervals, total number of injections over 1 year, recurrence rate and safety profiles of both drugs.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel interventional arms with option of rescue treatmentParallel interventional arms with option of rescue treatment
Masking:
Single (Participant)
Masking Description:
Patients are randomised and masked from the treatment
Primary Purpose:
Treatment
Official Title:
Treatment of Recalcitrant Neovascular AMD Using Brolocizumab With a Novel Treat and Extend Protocol - a Randomized Controlled Prospective Study
Actual Study Start Date :
Jul 25, 2022
Anticipated Primary Completion Date :
Jul 25, 2023
Anticipated Study Completion Date :
Aug 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Brolucizumab

new drug (brolocizumab) and novel treatment protocol

Drug: Brolucizumab
Intravitreal injection
Other Names:
  • Beovu

    		•
    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

    Drug: Aflibercept
    Intravitreal injection
    Other Names:
  • Eylea

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Central Macular thickness [1 year]

      Measurement of the change in macular thickness (um)

    Secondary Outcome Measures

    1. Visual acuity [1 year]

      Change in best corrected visual acuity (BCVA), LogMAR

    2. Treatment interval [1 year]

      Change in the duration of the treatment interval between each injection (weeks)

    3. Complications [1 year]

      Relating to the drug (eg. Inflammation), relating to the procedure (glaucoma, cataract, retinal detachment, haemorrhage etc)

    4. Optical Coherence Tomography features [1 year]

      Changes and presence of OCT features during every follow up visit (sub retinal fluid, intraretinal fluid, pigmented epithelial defect)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age 50 and above

    • Diagnosis of exudative age-related macular degeneration (subfoveal CNV) as shown on optical coherence tomography (OCT) - presence of intraretinal fluid, subretinal fluid or subretinal hyperreflective material and/or FFA (leakage classified as subfoveal or as juxtafoveal or extrafoveal)

    • Actively treated with aflibercept and given 3 monthly loading doses followed by treat and extend

    • Maximal interval period is less than or equal to 8 weekly injections

    • Patients must understand and sign the ethics board approved consent form

    Exclusion Criteria:

    • Ocular criteria:

    • Co-existing retinal and/or macular disease (DME, RVO, high myopia of 8 diopters or more, retinal detachment, macular hole stage 2 or above, significant vitreomacular traction or epiretinal membrane, etc.)

    • Co-existing ocular disease (glaucoma, uveitis etc.)

    • History of uveitis or intraocular inflammation, scleritis, or episcleritis

    • History of corneal transplant, pars planar vitrectomy or aphakia

    • History of therapeutic radiation to the region of the study eye

    • Media opacity obstructing investigation or assessment (cataract, corneal scar, vitreous hemorrhage)

    • Treat and extend period beyond 8 weeks

    • Any intravitreal injection of steroid within 3 months before randomization

    • Systemic criteria:

    • Poorly controlled systemic disease including hypertension and diabetes

    • Any acute coronary event or stroke within 6 months before randomization

    • Malignancy within 5 years

    • Systemic anti-VEGF treatment

    • Allergy or sensitivity to investigational product, including fluoresceine dye, anesthetics, aflibercept or brolucizumab

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Grantham Hospital Hong Kong Hong Kong

    Sponsors and Collaborators

    • The University of Hong Kong

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dr. Nicholas Fung, Clinical Assistant Professor, The University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT05710471
    Other Study ID Numbers:
    • Switch Study
    First Posted:
    Feb 2, 2023
    Last Update Posted:
    Feb 9, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Macular Degeneration
    Aflibercept

    Study Results

    No Results Posted as of Feb 9, 2023