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

May 6, 2024 updated by: Dr. Nicholas Fung, The University of Hong Kong

Treatment of Recalcitrant Neovascular AMD Using Brolocizumab With a Novel Treat and Extend Protocol - a Randomized Controlled Prospective Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Grantham Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central Macular thickness
Time Frame: 1 year
Measurement of the change in macular thickness (um)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: 1 year
Change in best corrected visual acuity (BCVA), LogMAR
1 year
Treatment interval
Time Frame: 1 year
Change in the duration of the treatment interval between each injection (weeks)
1 year
Complications
Time Frame: 1 year
Relating to the drug (eg. Inflammation), relating to the procedure (glaucoma, cataract, retinal detachment, haemorrhage etc)
1 year
Optical Coherence Tomography features
Time Frame: 1 year
Changes and presence of OCT features during every follow-up visit
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2022

Primary Completion (Actual)

July 25, 2023

Study Completion (Actual)

August 30, 2023

Study Registration Dates

First Submitted

January 25, 2023

First Submitted That Met QC Criteria

January 25, 2023

First Posted (Actual)

February 2, 2023

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Switch Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

By direct contact to the corresponding author or principle investigator

IPD Sharing Time Frame

5 years after study ends

IPD Sharing Access Criteria

Case by case

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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