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



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:2/23/2019
Start Date:October 30, 2018
End Date:June 9, 2020
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:1-888-669-6682

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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)

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.


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

- Previous treatment with brolucizumab in the study eye

- 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
We found this trial at
39
sites
Paducah, Kentucky 42003
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Abilene, Texas 79606
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Austin, Texas 78759
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Beverly Hills, California 90211
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Boston, Massachusetts 02118
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Charlotte, North Carolina 28277
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Cleveland, Ohio 44109
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Deerfield Beach, Florida 33064
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Eugene, Oregon 97401
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Fairfield, Ohio 45014
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Fort Myers, Florida 33912
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Fort Worth, Texas 76104
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Germantown, Tennessee 38138
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Golden, Colorado 80401
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Harlingen, Texas 78550
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Houston, Texas 77030
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Huntington Beach, California 92647
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Kingston, Pennsylvania 18704
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Las Vegas, Nevada 89135
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Marietta, Georgia 30060
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Miami, Florida 33136
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Mount Dora, Florida 32757
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Mountain View, California 94040
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New Orleans, Louisiana 70115
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Oakland, California 94612
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Ocala, Florida 34471
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Pensacola, Florida 32504
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Phoenix, Arizona 85012
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Redlands, California 92374
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Reno, Nevada 89502
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Royal Oak, Michigan 48073
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Sacramento, California 95825
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San Antonio, Texas 78207
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Santa Barbara, California 93108
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Shawnee Mission, Kansas 66204
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Spokane, Washington 99202
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Springfield, Massachusetts 01104
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Stuart, Florida 34995
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Syracuse, New York 13210
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