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NCT05710471
Treatment of Recalcitrant Neovascular AMD Using Brolocizumab With Immediate T&E
Conditions: Age-Related Macular Degeneration
Sex: All
Ages: 50 Years – N/A
Phase: PHASE4
Enrollment: 64
Sponsor: The University of Hong Kong
Location: Hong Kong
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
Eligibility Criteria
Inclusion Criteria:Age 50 and aboveDiagnosis 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 extendMaximal interval period is less than or equal to 8 weekly injectionsPatients must understand and sign the ethics board approved consent formExclusion 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 episcleritisHistory of corneal transplant, pars planar vitrectomy or aphakiaHistory of therapeutic radiation to the region of the study eyeMedia opacity obstructing investigation or assessment (cataract, corneal scar, vitreous hemorrhage)Treat and extend period beyond 8 weeksAny intravitreal injection of steroid within 3 months before randomizationSystemic criteria:Poorly controlled systemic disease including hypertension and diabetesAny acute coronary event or stroke within 6 months before randomizationMalignancy within 5 yearsSystemic anti-VEGF treatmentAllergy or sensitivity to investigational product, including fluoresceine dye, anesthetics, aflibercept or brolucizumab
Source: ClinicalTrials.gov (NCT05710471). StuddyBuddy aggregates publicly available trial information.