A Proof-of-Concept Study of RO6867461 in Participants With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)



Status:Completed
Conditions:Cardiology, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:9/29/2018
Start Date:August 11, 2015
End Date:September 26, 2017

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Trial Summary
Trial Overview
Inclusion Criteria

A Multiple-Center, Multiple-Dose and Regimen, 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 Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

This multiple-center, multiple-dose and regimen, randomized, double-masked active
comparator-controlled, double-masked, five parallel group, 36-week study will evaluate the
efficacy, safety, tolerability, and pharmacokinetics of RO6867461 in participants with CNV
secondary to AMD.


Inclusion Criteria:

- Treatment-naive with CNV secondary to AMD, with subfoveal CNV or juxtafoveal CNV with
a subfoveal component related to the CNV activity by FFA or SD-OCT

- Active CNV

Exclusion Criteria:

- CNV due to causes other than AMD

- Subretinal hemorrhage, fibrosis, or atrophy involving either the fovea or more than
50% of the total lesion area

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

- Major illness or surgery within 1 month prior to Screening

- Glycosylated hemoglobin (HbA1c) above 7.5%

- Uncontrolled blood pressure
We found this trial at
59
sites
Southern Vitreoretinal Assoc
2439 Care Drive
Tallahassee, Florida 32308
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Tallahassee, FL
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W Texas Retina Consultants PA
5441 Health Center Drive
Abilene, Texas 79606
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Abilene, TX
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Eye Associates of New Mexico
Albuquerque, New Mexico 87109
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Albuquerque, NM
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West Carolina Retinal AssocPA
21 Medical Park Drive
Asheville, North Carolina 28803
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from
Asheville, NC
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Southeast Retina Center, P.C.
Augusta, Georgia 30909
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from
Augusta, GA
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Austin Retina Associates
Austin, Texas 78705
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Austin, TX
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Retina Research Center
Austin, Texas 78705
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Austin, TX
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California Retina Consultants
Bakersfield, California 93309
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Bakersfield, CA
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Wilmer Eye Institute
Baltimore, Maryland
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Baltimore, MD
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Retina-Vitreous Associates Medical Group
Beverly Hills, California 90211
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Beverly Hills, CA
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Char Eye Ear &Throat Assoc
6035 Fairview Road
Charlotte, North Carolina 28210
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from
Charlotte, NC
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Univ of Virginia Ophthalmology
1300 Jefferson Park Avenue
Charlottesville, Virginia 22903
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from
Charlottesville, VA
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Southeastern Retina Associates Chattanooga
1606 Gunbarrel Road
Chattanooga, Tennessee 37421
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from
Chattanooga, TN
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Retina Group of Washington
Chevy Chase, Maryland 20815
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from
Chevy Chase, MD
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Retina Consultants of Southern
2770 North Union Boulevard
Colorado Springs, Colorado 80909
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from
Colorado Springs, CO
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OSU Eye Physicians and Surgeons, LLC.
Columbus, Ohio 43212
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from
Columbus, OH
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Texas Retina Associates
Dallas, Texas 75231
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from
Dallas, TX
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Vitreoretinal Surgery
7760 France Avenue South
Edina, Minnesota 55435
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from
Edina, MN
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The Retina Partners
Encino, California 91436
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Encino, CA
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Oregon Retina, LLP
Eugene, Oregon 97401
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from
Eugene, OR
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Palmetto Retina Center, LLC
Florence, South Carolina 29501
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from
Florence, SC
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Retina Health Center
Fort Myers, Florida 33907
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from
Fort Myers, FL
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National Ophthalmic Research Institute
Fort Myers, Florida 33912
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Fort Myers, FL
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Retina Consultants of Orange County
Fullerton, California 92835
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Fullerton, CA
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Charles Retina Institution
1432 Kimbrough Road
Germantown, Tennessee 38138
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Germantown, TN
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Colorado Retina Associates
Golden, Colorado 80401
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Golden, CO
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New England Retina Associates
Hamden, Connecticut 06518
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from
Hamden, CT
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Long Is. Vitreoretinal Consult
200 Motor Parkway
Hauppauge, New York 11788
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from
Hauppauge, NY
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Graystone Eye
2424 Century Place Southeast
Hickory, North Carolina 28603
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Hickory, NC
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Retina Consultants of Houston
Houston, Texas 77030
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Houston, TX
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Midwest Eye Institute Northside
10300 North Illinois Street
Indianapolis, Indiana 46290
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from
Indianapolis, IN
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Opthalmic Consultants of LI
360 Merrick Road
Lynbrook, New York 11563
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Lynbrook, NY
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Georgia Retina, P.C.
Marietta, Georgia 30060
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Marietta, GA
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Oregon Retina Institute
1518 East Barnett Road
Medford, Oregon 97504
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Medford, OR
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Florida Eye Associates
502 East New Haven Avenue
Melbourne, Florida 32901
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Melbourne, FL
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Tennessee Retina, P.C.
Nashville, Tennessee 37203
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Nashville, TN
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Ophthalmic Clinical Trials San Diego
Oceanside, California 92056
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Oceanside, CA
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Central Florida Retina
44 Lake Beauty Drive
Orlando, Florida 32806
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Orlando, FL
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Paducah Retinal Center
Paducah, Kentucky 42001
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Paducah, KY
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Retina Care Specialists
Palm Beach Gardens, Florida 33410
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Palm Beach Gardens, FL
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Mid-Atlantic Retina
Philadelphia, Pennsylvania 19107
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Philadelphia, PA
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Retinal Consultants of Arizona
Phoenix, Arizona 85014
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Phoenix, AZ
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Associated Retina Consultants
Phoenix, Arizona 85020
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Phoenix, AZ
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Retina Northwest, PC
Portland, Oregon 97210
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Portland, OR
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Retina Consultants, San Diego
Poway, California 92064
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Poway, CA
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Retina Assoc of Western NY
160 Sawgrass Drive
Rochester, New York 14620
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Rochester, NY
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Retina Vitreous Assoc of FL
4344 Central Avenue North
Saint Petersburg, Florida 33711
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Saint Petersburg, FL
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Retina Associates of Utah
Salt Lake City, Utah
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Salt Lake City, UT
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Orange County Retina Medical Group
Santa Ana, California 92705
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Santa Ana, CA
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Retina Consultants
SLingerlands, New York 12159
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SLingerlands, NY
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Spokane Eye Clinical Research
Spokane, Washington 99204
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Spokane, WA
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Retina Associates of NJ
628 Cedar Lane
Teaneck, New Jersey 07666
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Teaneck, NJ
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National Retina Institute
Towson, Maryland 21204
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Towson, MD
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Retina Centers, P.C.
Tucson, Arizona 85704
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Tucson, AZ
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Miramar Eye Specialists
Ventura, California 93003
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Ventura, CA
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Bay Area Retina Associates
Walnut Creek, California 94598
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Walnut Creek, CA
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American Institute of Research
Whittier, California 90603
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Whittier, CA
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Strategic Clinical Research Group, LLC
Willow Park, Texas 76087
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Willow Park, TX
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Vitreo-Retinal Associates, PC
Worcester, Massachusetts 01605
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Worcester, MA
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