Extension Study for the Port Delivery System With Ranibizumab (Portal)



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:4/5/2019
Start Date:September 20, 2018
End Date:June 24, 2022
Contact:Reference Study ID Number: GR40549 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration

This study will evaluate the long-term safety and tolerability of the Port Delivery System
(PDS) with ranibizumab 100 mg/mL with refills administered every 24 weeks (Q24W) for
approximately 144 weeks in participants with neovascular age-related macular degeneration
(nAMD) who have completed either Phase II Study GX28228 or Phase III Study GR40548.


Inclusion Criteria:

- Previous enrollment in and completion of Study GX28228 or Study GR40548, without early
treatment or study discontinuation in either study

- Ability and willingness to undertake all scheduled visits and assessments

- For women of childbearing potential: agreement to remain abstinent or use
contraceptive measures

Exclusion Criteria:

- Pregnant or breastfeeding, or intending to become pregnant during the treatment period
and for at least 28 days after the last intravitreal injection of ranibizumab or 1
year after the last Implant refill of ranibizumab

- History of other ocular diseases that give reasonable suspicion of a disease or
condition that contraindicates the use of ranibizumab, that might affect
interpretation of the results of the study or that renders the participant at high
risk for treatment complications

- History of other diseases, metabolic dysfunction, or clinical laboratory finding
giving reasonable suspicion of a disease or condition that contraindicates the use of
ranibizumab or placement of the Implant and that might affect interpretation of the
results of the study or that renders the participant at high risk of treatment
complications

- Requirement for continuous use of any medications or treatments indicated in the
"Prohibited Therapy"
We found this trial at
47
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Cincinnati, Ohio 45242
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1 University of New Mexico
Albuquerque, New Mexico 87131
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Arlington, Texas 76012
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Augusta, Georgia 30909
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Austin, Texas 78705
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Austin, TX
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600 North Wolfe Street
Baltimore, Maryland 21287
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Baltimore, MD
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Bloomfield, New Jersey 07003
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Bloomfield, NJ
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1717 Woolbright Road
Boynton Beach, Florida 33426
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Boynton Beach, FL
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6035 Fairview Road
Charlotte, North Carolina 28210
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Charlotte, NC
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8 Ranoldo Terrace
Cherry Hill, New Jersey 08034
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Chevy Chase, Maryland 20815
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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7760 France Avenue South
Edina, Minnesota 55435
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Edina, MN
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Encino, California 91436
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Encino, CA
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Florence, South Carolina 29501
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Fort Myers, Florida 33912
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1432 Kimbrough Road
Germantown, Tennessee 38138
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Golden, Colorado 80401
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Grand Rapids, Michigan 49546
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Houston, Texas 77030
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Joliet, Illinois 60435
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9415 Campus Point Drive
La Jolla, California 92093
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Lexington, Kentucky 40509
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Los Angeles, California
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2485 Hospital Drive
Mountain View, California 94040
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Nashville, Tennessee 37203
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1800 Republic Road
Norfolk, Virginia 23451
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Paducah, Kentucky 42001
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Pensacola, Florida 32503
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Phoenix, Arizona 85020
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Phoenix, Arizona 85014
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Portland, Oregon 97210
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3303 Southwest Bond Avenue
Portland, Oregon 97239
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Reno, Nevada 89502
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160 Sawgrass Drive
Rochester, New York 14620
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Sacramento, California 95819
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4344 Central Avenue North
Saint Petersburg, Florida 33711
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Salt Lake City, Utah
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9157 Huebner Road
San Antonio, Texas 78240
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San Francisco, California 94107
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400 Parnassus Avenue
San Francisco, California 94143
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Santa Ana, California 92705
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Santa Barbara, California 93103
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Sun City, Arizona 85351
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Tampa, Florida 33609
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Towson, Maryland 21204
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West Des Moines, Iowa 50266
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