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

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)

ClinicalTrials.gov Identifier: NCT03710564

Novartis Reference Number: CRTH258AUS04

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this study is to compare safety and efficacy of brolucizumab 6 mg dosed every 4 weeks to aflibercept 2 mg dosed every 4 weeks in those nAMD patients with retinal fluid despite frequent anti-Vascular Endothelial Growth Factor (VEGF) injections.

Condition 
Age-Related Macular Degeneration
Phase 
Phase 3
Overall status 
Active, not recruiting
Enrollment count 
530 participants
Start date 
Oct 30, 2018
Completion date 
Jan 14, 2022
Gender 
All
Age(s)
50 Years and older (Adult, Older Adult)

Interventions

Biological
Brolucizumab
6 mg/0.05mL solution for intravitreal injection
Biological
Aflibercept
2 mg/0.05mL solution for intravitreal injection

Eligibility Criteria

Inclusion Criteria:

Sign 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

Other protocol-defined inclusion/exclusion criteria may apply

Study Locations

United States
Novartis Investigative Site
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Phoenix, 85016
Arizona
United States
Novartis Investigative Site
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Phoenix, 85020
Arizona
United States
Novartis Investigative Site
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Phoenix, 85053
Arizona
United States
Novartis Investigative Site
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Beverly Hills, 90211
California
United States
Novartis Investigative Site
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Huntington Beach, 92647
California
United States
Novartis Investigative Site
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Mountain View, 94040
California
United States
Novartis Investigative Site
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Oakland, 94609
California
United States
Novartis Investigative Site
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Oxnard, 93036
California
United States
Novartis Investigative Site
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Palo Alto, 94303
California
United States
Novartis Investigative Site
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Redlands, 92374
California
United States
Novartis Investigative Site
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Sacramento, 95841
California
United States
Novartis Investigative Site
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San Francisco, 94107
California
United States
Novartis Investigative Site
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Santa Barbara, 93103
California
United States
Novartis Investigative Site
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Colorado Springs, 80909
Colorado
United States
Novartis Investigative Site
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Golden, 80401
Colorado
United States
Novartis Investigative Site
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Deerfield Beach, 33064
Florida
United States
Novartis Investigative Site
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Fort Lauderdale, 33308
Florida
United States
Novartis Investigative Site
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Fort Myers, 33912-7125
Florida
United States
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Miami, 33136
Florida
United States
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Mount Dora, 32757
Florida
United States
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Pensacola, 32503
Florida
United States
Novartis Investigative Site
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Saint Petersburg, 33711
Florida
United States
Novartis Investigative Site
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Stuart, 34994
Florida
United States
Novartis Investigative Site
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Marietta, 30060
Georgia
United States
Novartis Investigative Site
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'Aiea, 96701
Hawaii
United States
Novartis Investigative Site
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Wheaton, 60187
Illinois
United States
Novartis Investigative Site
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West Des Moines, 50266
Iowa
United States
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Shawnee Mission, 66204
Kansas
United States
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New Orleans, 70115-8139
Louisiana
United States
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West Monroe, 71291
Louisiana
United States
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Waldorf, 20602
Maryland
United States
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Boston, 02111
Massachusetts
United States
Novartis Investigative Site
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Boston, 02114
Massachusetts
United States
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Springfield, 01107
Massachusetts
United States
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Royal Oak, 48073
Michigan
United States
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Saint Louis, 63110
Missouri
United States
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Las Vegas, 89144
Nevada
United States
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Reno, 89502
Nevada
United States
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Bloomfield, 07003
New Jersey
United States
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Toms River, 08755
New Jersey
United States
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Syracuse, 13224
New York
United States
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Charlotte, 28210
North Carolina
United States
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Cleveland, 44122
Ohio
United States
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Fairfield, 45014
Ohio
United States
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Eugene, 97401
Oregon
United States
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Kingston, 95403
Pennsylvania
United States
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Philadelphia, 19107
Pennsylvania
United States
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Germantown, 38138
Tennessee
United States
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Abilene, 79606
Texas
United States
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Austin, 78705
Texas
United States
Novartis Investigative Site
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Austin, 78731
Texas
United States
Novartis Investigative Site
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Austin, 78793
Texas
United States
Novartis Investigative Site
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Fort Worth, 76102
Texas
United States
Novartis Investigative Site
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Fort Worth, 76104
Texas
United States
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Harlingen, 78550
Texas
United States
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Houston, 77030
Texas
United States
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San Antonio, 78240
Texas
United States
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Tyler, 75701
Texas
United States
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Fairfax, 22031
Virginia
United States
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Spokane, 99204
Washington
United States
Puerto Rico
Novartis Investigative Site
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Arecibo, 00612
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Puerto Rico

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