Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema



Status:Recruiting
Conditions:Cardiology, Ocular, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:3/3/2019
Start Date:January 21, 2018
End Date:August 13, 2021
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:1-888-669-6682

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A Two-year, Three-arm, Randomized, Double-masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Diabetic Macular Edema

The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment
of patients with visual impairment due to diabetic macular edema (DME).

In this 2-year, randomized, double-masked, multicenter, active controlled study, consenting
patients will be randomized in a 1:1:1 ratio to one of the three treatment arms (Brolucizumab
3 mg, Brolucizumab 6 mg, or Aflibercept 2 mg) and attend 28 planned visits.

Inclusion Criteria:

- Written informed consent before any assessment

- Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at screening

- Medication for the management of diabetes stable within 3 months prior to
randomization and is expected to remain stable during the course of the study

Exclusion Criteria:

- Active proliferative diabetic retinopathy in the study eye

- Active intraocular or periocular infection or active intraocular inflammation in study
eye

- Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25
millimeters mercury (mmHg)

- Previous treatment with anti-VEGF drugs or investigational drugs in the study eye

- Stroke or myocardial infarction during the 6-month period prior to baseline

- Uncontrolled blood pressure defined as a systolic value ≥160 mmHg or diastolic value
≥100 mmHg

Other protocol-specified inclusion/exclusion criteria may apply
We found this trial at
34
sites
Philadelphia, Pennsylvania 19102
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Austin, Texas 78759
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Beverly Hills, California 90211
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Charlotte, North Carolina 28277
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Cincinnati, Ohio 45229
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Cleveland, Ohio 44109
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Colorado Springs, Colorado 80907
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Danbury, Connecticut 06810
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Fort Myers, Florida 33912
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Fort Myers, FL
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Harlingen, Texas 78550
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Houston, Texas 77030
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Indianapolis, Indiana 46202
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Kingston, Pennsylvania 18704
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La Jolla, California 92037
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Leawood, Kansas 66211
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Madison, Wisconsin 53705
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Medford, Oregon 97504
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Memphis, Tennessee 38120
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Miami, Florida 33136
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Nashville, Tennessee 37205
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New Albany, Indiana 47150
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Paducah, Kentucky 42003
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Phoenix, Arizona 85012
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Plano, Texas 75024
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Reno, Nevada 89502
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Rosario, Provincia De Santa Fe
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Santa Barbara, California 93108
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Shawnee Mission, Kansas 66204
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Silverdale, Washington 98383
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Spokane, Washington 99202
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Stoneham, Massachusetts 02180
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Stuart, Florida 34995
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Tyler, Texas 75701
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Wheaton, Illinois 60187
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