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
sites
Augusta, Georgia 30909
2059
mi
from 91732
Augusta, GA
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1 University of New Mexico
Albuquerque, New Mexico 87131
651
mi
from 91732
Albuquerque, NM
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Arlington, Texas 76012
1205
mi
from 91732
Arlington, TX
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Austin, Texas 78705
1211
mi
from 91732
Austin, TX
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600 North Wolfe Street
Baltimore, Maryland 21287
2302
mi
from 91732
Baltimore, MD
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Bloomfield, New Jersey 07003
2423
mi
from 91732
Bloomfield, NJ
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1717 Woolbright Road
Boynton Beach, Florida 33426
2308
mi
from 91732
Boynton Beach, FL
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6035 Fairview Road
Charlotte, North Carolina 28210
2102
mi
from 91732
Charlotte, NC
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8 Ranoldo Terrace
Cherry Hill, New Jersey 08034
2384
mi
from 91732
Cherry Hill, NJ
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Chevy Chase, Maryland 20815
2278
mi
from 91732
Chevy Chase, MD
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Cincinnati, Ohio 45242
1880
mi
from 91732
Cincinnati, OH
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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...
2033
mi
from 91732
Cleveland, OH
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7760 France Avenue South
Edina, Minnesota 55435
1504
mi
from 91732
Edina, MN
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Encino, California 91436
27
mi
from 91732
Encino, CA
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Florence, South Carolina 29501
2174
mi
from 91732
Florence, SC
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Fort Myers, Florida 33912
2209
mi
from 91732
Fort Myers, FL
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1432 Kimbrough Road
Germantown, Tennessee 38138
1601
mi
from 91732
Germantown, TN
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Golden, Colorado 80401
807
mi
from 91732
Golden, CO
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Grand Rapids, Michigan 49546
1847
mi
from 91732
Grand Rapids, MI
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Houston, Texas 77030
1357
mi
from 91732
Houston, TX
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Joliet, Illinois 60435
1701
mi
from 91732
Joliet, IL
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9415 Campus Point Drive
La Jolla, California 92093
94
mi
from 91732
La Jolla, CA
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Lexington, Kentucky 40509
1886
mi
from 91732
Lexington, KY
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Los Angeles, California
13
mi
from 91732
Los Angeles, CA
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2485 Hospital Drive
Mountain View, California 94040
322
mi
from 91732
Mountain View, CA
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Nashville, Tennessee 37203
1762
mi
from 91732
Nashville, TN
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1800 Republic Road
Norfolk, Virginia 23451
2351
mi
from 91732
Norfolk, VA
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Paducah, Kentucky 42001
1659
mi
from 91732
Paducah, KY
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Pensacola, Florida 32503
1810
mi
from 91732
Pensacola, FL
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Phoenix, Arizona 85020
343
mi
from 91732
Phoenix, AZ
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Phoenix, Arizona 85014
344
mi
from 91732
Phoenix, AZ
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Portland, Oregon 97210
827
mi
from 91732
Portland, OR
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3303 Southwest Bond Avenue
Portland, Oregon 97239
826
mi
from 91732
Portland, OR
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Reno, Nevada 89502
385
mi
from 91732
Reno, NV
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160 Sawgrass Drive
Rochester, New York 14620
2245
mi
from 91732
Rochester, NY
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Sacramento, California 95819
366
mi
from 91732
Sacramento, CA
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4344 Central Avenue North
Saint Petersburg, Florida 33711
2127
mi
from 91732
Saint Petersburg, FL
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Salt Lake City, Utah
570
mi
from 91732
Salt Lake City, UT
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9157 Huebner Road
San Antonio, Texas 78240
1180
mi
from 91732
San Antonio, TX
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San Francisco, California 94107
353
mi
from 91732
San Francisco, CA
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400 Parnassus Avenue
San Francisco, California 94143
356
mi
from 91732
San Francisco, CA
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Santa Ana, California 92705
23
mi
from 91732
Santa Ana, CA
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Santa Barbara, California 93103
98
mi
from 91732
Santa Barbara, CA
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Sun City, Arizona 85351
331
mi
from 91732
Sun City, AZ
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Tampa, Florida 33609
2133
mi
from 91732
Tampa, FL
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Towson, Maryland 21204
2301
mi
from 91732
Towson, MD
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West Des Moines, Iowa 50266
1415
mi
from 91732
West Des Moines, IA
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