Study of Safety and Efficacy of Brolucizumab 6 mg Dosed Every 4 Weeks Compared to Aflibercept 2 mg Dosed Every 4 Weeks in Patients With Retinal Fluid Despite Frequent Anti-VEGF Injections (MERLIN)

Novartis

Status and phase: Terminated; Phase 3

Conditions: Age-Related Macular Degeneration

Treatments: Biological: Aflibercept; Biological: Brolucizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03710564

CRTH258AUS04

Details and patient eligibility

About

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.

Full description

This was a Phase III, multi-center, randomized, double-masked, parallel group study with 2 masked arms in which participants were randomized 2:1 to receive brolucizumab or aflibercept. All participants had study visits every 4 weeks through week 104.

The study consisted of three study periods:

Screening Period: The screening period lasted up to 2 weeks prior to administration of the first dose of study treatment, dependent upon confirmation of the patient meeting eligibility criteria.

Double-Masked Treatment Period: Participants meeting eligibility criteria entered the treatment period and were randomized in a 2:1 ratio into one of the following 2 masked treatment arms at the Baseline visit: Brolucizumab 6 mg injected every 4 weeks or Aflibercept 2 mg injected every 4 weeks. Treatment period lasted up to week 100.

Safety Follow up Period: Participants were followed up for safety during 4 weeks after the last dose of study treatment. Including the Screening Period, the total study duration for a participant was up to 106 weeks.

Some participants were eligible to continue into an extension study in order to receive treatment with brolucizumab (a) after completing the 104 -week double-masked treatment period, (b) upon meeting all inclusion/exclusion criteria for the extension study, and (c) based on Investigator's judgment that the participant was expected to benefit from treatment with brolucizumab.

Enrollment: 535 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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535 participants in 2 patient groups

Brolucizumab

Experimental group

Description:

Brolucizumab 6 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.

Treatment:

Biological: Brolucizumab

Aflibercept

Active Comparator group

Description:

Aflibercept 2 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.

Treatment:

Biological: Aflibercept