Study to Evaluate Faricimab (RO6867461; RG7716) for Extended Durability in the Treatment of Neovascular Age Related Macular Degeneration (nAMD)



Status:Completed
Conditions:Cardiology, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:1/17/2019
Start Date:January 27, 2017
End Date:March 29, 2018

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Trial Summary
Trial Overview
Inclusion Criteria

STAIRWAY: Simultaneous Blockade of Angiopoietin-2 and VEGF-A With the Bispecific Antibody RO6867461 (RG7716) for Extended Durability in the Treatment of Neovascular Age-Related Macular Degeneration

This is a Phase II, multicenter, randomized, active comparator-controlled, 52-week study to
investigate the efficacy, safety and pharmacokinetics of faricimab (RO6867461; RG7716)
administered with extended dosing regimens in treatment-naive participants with nAMD. Only
one eye will be chosen as the study eye.


Inclusion Criteria

- Treatment-naive CNV secondary to AMD

- Subfoveal or juxtafoveal CNV with a subfoveal component related to the CNV activity

- Active CNV

- BCVA letter score of 73 to 24 letters (inclusive)

Exclusion Criteria:

- CNV due to causes other than AMD

- Retinal pigment epithelial tear involving the macula

- On fundus fluorescein angiography (FFA) subretinal hemorrhage, fibrosis or atrophy of
>50% of the total lesion area and/or that involves the fovea

- Cataract surgery within 3 months of baseline assessments

- Uncontrolled blood pressure
We found this trial at
33
sites
Southern Vitreoretinal Assoc
2439 Care Drive
Tallahassee, Florida 32308
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Tallahassee, FL
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Retina Res Institute of Texas
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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Texas Retina Associates
Arlington, Texas 76012
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from
Arlington, TX
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Southeast Retina Center, P.C.
Augusta, Georgia 30909
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from
Augusta, GA
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Retina Research Center
Austin, Texas 78705
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from
Austin, TX
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Austin Retina Associates
Austin, Texas 78705
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from
Austin, TX
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California Retina Consultants
Bakersfield, California 93309
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from
Bakersfield, CA
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The Retina Care Center
Baltimore, Maryland 21209
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Baltimore, MD
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Retinal Diagnostic Center
Campbell, California 95008
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from
Campbell, 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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Southeastern Retina Associates Chattanooga
1606 Gunbarrel Road
Chattanooga, Tennessee 37421
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mi
from
Chattanooga, TN
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Mid Atlantic Retina - Wills Eye Hospital
8 Ranoldo Terrace
Cherry Hill, New Jersey 08034
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from
Cherry Hill, NJ
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Retina Assoc. of Cleveland
Cleveland, Ohio 44122
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from
Cleveland, OH
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Retina Consultants of Southern Colorado PC; Clinical Research Department
2770 North Union Boulevard
Colorado Springs, Colorado 80909
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from
Colorado Springs, CO
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Rand Eye
5 West Sample Road
Deerfield Beach, Florida 33064
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from
Deerfield Beach, FL
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Oregon Retina, LLP
Eugene, Oregon 97401
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mi
from
Eugene, OR
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National Ophthalmic Research Institute
Fort Myers, Florida 33912
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from
Fort Myers, FL
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Charles Retina Institution
1432 Kimbrough Road
Germantown, Tennessee 38138
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from
Germantown, TN
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Colorado Retina Associates
Golden, Colorado 80401
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from
Golden, CO
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Vitreoretinal Consultants
600 Northern Blvd # 216
Great Neck, New York 11021
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from
Great Neck, NY
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Midwest Eye Institute
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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from
Lynbrook, NY
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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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Vitreo Retinal Surgery
Minneapolis, Minnesota 55435
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from
Minneapolis, MN
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Retinal Consultants of Arizona
Phoenix, Arizona 85014
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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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Sierra Eye Associates
Reno, Nevada 89502
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Reno, NV
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Retina Vitreous Assoc of FL
4344 Central Avenue North
Saint Petersburg, Florida 33711
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from
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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Retina Associates Southwest, PC
Tucson, Arizona 85724
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Tucson, AZ
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Wolfe Eye Clinic
West Des Moines, Iowa 50266
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from
West Des Moines, IA
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Strategic Clinical Research Group, LLC
Willow Park, Texas 76087
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from
Willow Park, TX
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