A Study of RO6867461 in Participants With Center-involving Diabetic Macular Edema



Status:Completed
Conditions:Cardiology, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:9/20/2018
Start Date:April 27, 2016
End Date:December 14, 2017

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A Multiple-center, Multiple-dose, Randomized, Active Comparator−Controlled, Double-masked, Parallel Group, 36-week Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO6867461 Administered Intravitreally in Patients With Diabetic Macular Edema

This is a multiple-center, multiple-dose, randomized, active comparator-controlled,
double-masked, three parallel group, 36-week study in participants with center-involving
diabetic macular edema (DME). Only one eye will be selected as the study eye. Where both eyes
meet all eligibility criteria, the eye with the worse best corrected visual acuity (BCVA)
will be defined as the study eye. The study will consist of a treatment period (20 weeks) and
an observational period (up to 16 weeks). Treatment naive participants will be randomized in
a 1:1:1 ratio to one of the Arms A, B and C, respectively. Participants previously treated
with intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) will be randomized in
a 1:1 ratio to Arms A and C.


Inclusion Criteria:

- Macular edema associated with diabetic retinopathy

- Decreased visual acuity attributable primarily to DME

- Diagnosis of diabetes mellitus

Exclusion Criteria:

- High risk proliferative diabetic retinopathy

- Cataract surgery within 3 months of Baseline, or any other previous intraocular
surgery

- Uncontrolled glaucoma

- Current or history of ocular disease in the study eye other than DME

- Major illness or major surgical procedure within 1 month prior to Day 1

- Uncontrolled blood pressure

- Glycosylated hemoglobin (HbA1c) greater than (>) 12 percent (%) at screening

- Untreated diabetes mellitus or initiation of oral anti-diabetic medication or insulin
within 4 months prior to Day 1
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5441 Health Center Drive
Abilene, Texas 79606
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Albany, New York 12206
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Albuquerque, New Mexico 87109
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Albuquerque, New Mexico 87131
(505) 277-0111
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Arlington, Texas 76012
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21 Medical Park Drive
Asheville, North Carolina 28803
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Augusta, Georgia 30909
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Austin, Texas 78705
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Bloomfield, New Jersey 07003
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220 Grandview Avenue
Camp Hill, Pennsylvania 17011
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6035 Fairview Road
Charlotte, North Carolina 28210
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22903
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
University of Illinois at Chicago A major research university in the heart of one of...
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Cincinnati, Ohio 45242
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2770 North Union Boulevard
Colorado Springs, Colorado 80909
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5 West Sample Road
Deerfield Beach, Florida 33064
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2625 Bolton Boone Drive
DeSoto, Texas 75115
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7760 France Avenue South
Edina, Minnesota 55435
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Eugene, Oregon 97401
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Florence, South Carolina 29501
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Fullerton, California 92835
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1432 Kimbrough Road
Germantown, Tennessee 38138
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Indianapolis, Indiana 46290
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433 North Prairie Avenue
Inglewood, California 90301
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9551 U.S. 78
Ladson, South Carolina 29456
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Laguna Hills, California 92653
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Lexington, Kentucky 40509
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Los Angeles, California
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360 Merrick Road
Lynbrook, New York 11563
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Marietta, Georgia 30060
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502 East New Haven Avenue
Melbourne, Florida 32901
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Morgantown, West Virginia 26506
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Mountain View, California 94040
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Nashville, Tennessee 37203
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Paducah, Kentucky 42001
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36949 Cook Street
Palm Desert, California 92211
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8411 North Run Medical Drive
Richmond, Virginia 23226
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Syracuse, New York 13224
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Tallahassee, Florida 32308
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The Woodlands, Texas 77384
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