A Multicenter, Randomized, Double-masked Phase 3a Study to Assess Safety and Efficacy of Brolucizumab 6 mg q4 Weeks Compared to Aflibercept 2 mg q4 Weeks in Patients With Neovascular Age-related Macular Degeneration (nAMD) With Persistent Retinal Fluid (MERLIN)

CRTH258AUS04

This clinical study was designed to compare the safety and efficacy of brolucizumab 6 mg dosed every 4 weeks to aflibercept 2 mg dosed every 4 weeks in those neovascular age-related macular degeneration (nAMD) patients with retinal fluid despite frequent anti-Vascular Endothelial Growth Factor (VEGF) injections.

2018-10-30

2020-12-21

2021-07-01

Terminated

Early phase I

535

Inclusion Criteria: * Signed informed consent * Diagnosis of wet age-related macular degeneration (AMD) * Currently receiving anti-VEGF injections Exclusion Criteria: * Active infection or inflammation in either eye * Significant fibrosis in the study eye * Recent ocular surgery * Uncontrolled glaucoma * Use of medications as specified in the protocol * Pregnant, nursing * Of child-bearing potential unless using highly effective method of contraception

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'multicenter, randomized, double-masked', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 535, 'type': 'ACTUAL'}}

2023-01-30