Treatment of Recalcitrant Neovascular AMD Using Brolocizumab With Immediate T&E
Age-Related Macular Degeneration
About this trial
This is an interventional treatment trial for Age-Related Macular Degeneration
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
Sites / Locations
- Grantham HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Brolucizumab
Aflibercept
new drug (brolocizumab) and novel treatment protocol
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