Status:
WITHDRAWN
Brolucizumab vs. Aflibercept for Retinal Angiomatous Proliferation
Lead Sponsor:
Faculty Hospital Kralovske Vinohrady
Conditions:
Wet Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
This is a prospective randomised study comparing two intravitreal antiVEGF drugs - brolucizumab and aflibercept - in the treatment of retinal angiomatous proliferation (RAP). Patients with RAP confirm...
Detailed Description
Retinal angiomatous proliferation (RAP) is one of the variants of wet form of age-related macular degeneration (wAMD). Neovascularization in RAP grows from the retinal deep capillary plexus into the s...
Eligibility Criteria
Inclusion
- age of 50 years or more at the time the informed consent is signed
- active RAP in the macula including fovea diagnosed on OCT and OCTA
- BCVA between 70 to 35 ETDRS letters (approx. 20/40 to 20/200 Snellen equivalent)
- decrease in BCVA caused primarily by the RAP in the study eye
- presence of intra- or subretinal fluid or PED in the central 1 mm of the macula on the OCT
- patient capable of signing the informed consent
Exclusion
- other causes of choroidal neovascular membrane (CNV) than wAMD
- previous or current conditions of the study eye:
- subretinal haemorrhage comprising more than 25% of the lesion in the study eye
- scar or fibrosis comprising more than 50% of the lesion in the study eye
- presence of retinal pigment epithelium (RPE) tears or ruptures in the central 1 mm of the macula in the study eye
- total lesion size more than 8 papillary diameters (PD) as per OCT and FP examination
- uncontrolled glaucoma in the study eye defined as IOP of more than 25 mmHg despite the antiglaucoma treatment
- idiopathic or autoimmune uveitis in the study eye
- other pathologies in the macula of the study eye which can be expected to influence the BCVA (e.g. macular hole, retinal atrophy, epiretinal membrane, etc.)
- history of glaucoma surgery in the study eye or probability that it will be necessary in the future
- aphakia or pseudophakia with absence of the posterior lens capsule (with the exception of missing posterior capsule due to Nd:YAG laser capsulotomy) in the study eye
- myopia in the study eye with spherical equivalent of more than 8 dioptries before any refractive or cataract surgery
- significant opacities of the ocular media in the study eye including cataract, which can interfere with BCVA assessment or FP or OCT examination
- corneal transplantation or corneal dystrophy in the study eye
- irregular astigmatism or BCVA-lowering amblyopia in the study eye
- diabetic retinopathy, diabetic macular edema or any other retinal vascular disease in the study eye
- extraocular or periocular infection or inflammation (e.g. blepharitis, keratitis, conjunctivitis, scleritis, etc.) in any eye at the time of screening or baseline visit
- any intraocular infection or inflammation in any eye during 12 weeks (84 days) before the screening visit
- allergy or hypersensitivity to any component contained in the study drug
- pregnant or breastfeeding women
Key Trial Info
Start Date :
January 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04698850
Start Date
January 4 2021
End Date
June 1 2023
Last Update
August 10 2022
Active Locations (1)
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1
Department of Ophthalmology, Faculty hospital Kralovske Vinohrady
Prague, Czechia, 100 34