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

• Status: Recruiting
• Trial end date: 2023-08-30
• Target enrollment: 0
• Participant gender: All

Summary

We propose to conduct a randomized clinical trial, investigating the safety and efficacy of brolucizumab for treatment of nAMD patients with CNV. We plan to specifically target those who are not responding to standard Treat and Extend (T&E) treatment. We will conduct a randomized study 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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Treatments: Aflibercept

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