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

Phase 4

Completed

• Conditions: Age-Related Macular Degeneration
• Interventions: Drug: Brolucizumab; Drug: Aflibercept

• Registration Number: NCT05710471
• Lead Sponsor: The University of Hong Kong

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

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 Timeline

• Study Start: 2022-07-25
• Study First Submitted: 2023-01-25
• Study First Submitted QC: 2023-01-25
• Study First Posted: 2023-02-02
• Primary Completion: 2023-07-25
• Study Completion: 2023-08-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brolucizumab	Brolucizumab	new drug (brolocizumab) and novel treatment protocol
Aflibercept	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 Measures

Name	Time	Method
Central Macular thickness	1 year	Measurement of the change in macular thickness (um)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Grantham Hospital; 🇭🇰 Hong Kong, Hong Kong