A Phase III Study to Evaluate the Port Delivery System Implant With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration (Archway)



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:4/5/2019
Start Date:September 12, 2018
End Date:May 26, 2022
Contact:Reference Study ID Number: GR40548 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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Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active-Comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration

Study GR40548 is a Phase III, randomized, multicenter, open-label (visual assessor
[VA]-masked), active-comparator study designed to assess the efficacy, safety, and
pharmacokinetics (PK) of 100mg/ml delivered via the Port Delivery System (PDS) compared with
ranibizumab intravitreal injections at 0.5 mg (10 mg/mL) in participants with neovascular
age-related macular degeneration (nAMD).


Inclusion Criteria:

- Age ≥50 years, at time of signing Informed Consent Form

- Initial diagnosis of exudative neovascular age-related macular degeneration (nAMD)
within 9 months prior to the screening visit

- Previous treatment with at least three anti-vascular endothelial growth factor
(anti-VEGF) intravitreal injections for nAMD per standard of care within 6 months
prior to the screening visit

- Demonstrated response to prior anti-VEGF intravitreal treatment since diagnosis

- Best-corrected visual acuity (BCVA) of 34 letters or better

Exclusion Criteria:

- Subfoveal fibrosis or subfoveal atrophy in study eye

- Subretinal hemorrhage that involves the center of the fovea in study eye

- History of vitrectomy surgery, submacular surgery, or other surgical intervention for
AMD in study eye

- Prior treatment with Visudyne®, external-beam radiation therapy, or transpupillary
thermotherapy in study eye

- Previous intraocular device implantation in study eye

- Previous laser (any type) used for AMD treatment in study eye

- Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the
randomization visit in either eye

- Prior participation in a clinical trial involving anti-VEGF drugs within 6 months
prior to the randomization visit, other than ranibizumab in either eye

- CNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
in either eye

- Uncontrolled blood pressure

- History of stroke within the last 3 months prior to informed consent

- Uncontrolled atrial fibrillation within 3 months of informed consent

- History of myocardial infarction within the last 3 months prior to informed consent

- History of other disease, 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 renders the participant at high risk of treatment
complications in the opinion of the investigator

- Current systemic treatment for a confirmed active systemic infection

- Chronic use of oral corticosteroids

- Active cancer within 12 months of randomization

- Previous participation in any non-ocular (systemic) disease studies of investigational
drugs within 1 month preceding the informed consent (excluding vitamins and minerals)
We found this trial at
90
sites
Grand Rapids, Michigan 45946
1793
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Grand Rapids, MI
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
2485
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Boston, MA
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
1393
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Minneapolis, MN
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1 University of New Mexico
Albuquerque, New Mexico 87131
1185
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Albuquerque, NM
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Arlington, Texas 76012
1667
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Arlington, TX
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Augusta, Georgia 30909
2300
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Augusta, GA
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Austin, Texas 78705
1769
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Austin, TX
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Austin, Texas 78705
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Bakersfield, California 93309
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Baltimore, Maryland 21209
2323
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Baltimore, MD
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600 North Wolfe Street
Baltimore, Maryland 21287
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Beverly Hills, California 90211
959
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Beverly Hills, CA
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Bloomfield, New Jersey 07003
2390
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Bloomfield, NJ
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Boston, Massachusetts 02114
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6035 Fairview Road
Charlotte, North Carolina 28210
2284
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Charlotte, NC
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8 Ranoldo Terrace
Cherry Hill, New Jersey 08034
2382
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Cherry Hill, NJ
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1815 Clarkson Road
Chesterfield, Missouri 63017
1703
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Chesterfield, MO
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226 South Woods Mill Road
Chesterfield, Missouri 63017
1706
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Chevy Chase, Maryland 20815
2317
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Chevy Chase, MD
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1733
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Chicago, IL
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Cincinnati, Ohio 45242
1967
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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...
2016
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Cleveland, OH
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2008
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Columbus, OH
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Durango, Colorado 81301
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Durango, CO
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7760 France Avenue South
Edina, Minnesota 55435
1390
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Edmond, Oklahoma 73013
1516
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Edmond, OK
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Encino, California 91436
952
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Encino, CA
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Florence, South Carolina 29501
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Florence, SC
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1725 East Prospect Road
Fort Collins, Colorado 80525
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Fort Myers, Florida 33907
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Fort Myers, Florida 33912
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1101 6th Avenue
Fort Worth, Texas 76104
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Fullerton, California 92835
975
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Fullerton, CA
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1432 Kimbrough Road
Germantown, Tennessee 38138
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Germantown, TN
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Golden, Colorado 80401
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Grand Rapids, Michigan 49546
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200 Motor Parkway
Hauppauge, New York 11788
2433
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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
2010
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Los Angeles, California
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Marietta, Georgia 30060
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McAllen, Texas 78503
1974
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502 East New Haven Avenue
Melbourne, Florida 32901
2603
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2485 Hospital Drive
Mountain View, California 94040
709
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Nashville, Tennessee 37203
1971
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460 Park Avenue
New York, New York 10022
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1800 Republic Road
Norfolk, Virginia 23451
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1736
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Oak Forest, IL
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Paducah, Kentucky 42001
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Palm Beach Gardens, Florida 33410
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2452 Watson Court
Palo Alto, California 94303
703
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Pensacola, Florida 32503
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Phoenix, Arizona 85014
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Phoenix, Arizona 85020
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Plantation, Florida 33324
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Portland, Maine
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Portland, Oregon 97210
147
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3303 Southwest Bond Avenue
Portland, Oregon 97239
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Poway, California 92064
1050
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Redlands, California 92374
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Reno, Nevada 89502
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Richmond, Virginia
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Rockville Centre, New York 11570
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Sacramento, California 95819
627
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4344 Central Avenue North
Saint Petersburg, Florida 33711
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Salt Lake City, Utah
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Salt Lake City, Utah 84107
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9157 Huebner Road
San Antonio, Texas 78240
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San Francisco, California 94107
681
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400 Parnassus Avenue
San Francisco, California 94143
681
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Santa Ana, California 92705
987
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Santa Barbara, California 93103
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Shawnee Mission, Kansas 66204
1503
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9800 Levin Road Northwest
Silverdale, Washington 98383
15
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SLingerlands, New York 12159
2348
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Spokane, Washington 99204
229
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Sun City, Arizona 85351
1102
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3107 East Genesee Street
Syracuse, New York 13224
2234
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2439 Care Drive
Tallahassee, Florida 32308
2330
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Tampa, Florida 33609
2525
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628 Cedar Lane
Teaneck, New Jersey 07666
2395
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The Woodlands, Texas 77384
1861
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Towson, Maryland 21204
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Walnut Creek, California 94598
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Waterford, Connecticut 06385
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West Des Moines, Iowa 50266
1457
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Worcester, Massachusetts 01605
2454
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