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

NCT ID: NCT05710471

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-25
• Study Completion Date: 2023-08-30

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.

Conditions

Age-Related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Brolucizumab

new drug (brolocizumab) and novel treatment protocol

Group Type: EXPERIMENTAL

Brolucizumab

Intervention Type: DRUG

Intravitreal injection

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

Group Type: ACTIVE_COMPARATOR

Aflibercept

Intervention Type: DRUG

Intravitreal injection

Interventions

Brolucizumab

Intravitreal injection

Intervention Type: DRUG

Aflibercept

Intravitreal injection

Intervention Type: DRUG

Other Intervention Names

Beovu; Eylea

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Nicholas Fung

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Grantham Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

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