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)

Use our guide to learn which trials are right for you!

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
2452 Watson Court
Palo Alto, California 94303
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
?
mi
from
Boston, MA
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
1 University of New Mexico
Albuquerque, New Mexico 87131
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Arlington, Texas 76012
?
mi
from
Arlington, TX
Click here to add this to my saved trials
Augusta, Georgia 30909
?
mi
from
Augusta, GA
Click here to add this to my saved trials
Austin, Texas 78705
?
mi
from
Austin, TX
Click here to add this to my saved trials
Austin, Texas 78705
?
mi
from
Austin, TX
Click here to add this to my saved trials
Bakersfield, California 93309
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
Baltimore, Maryland 21209
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
600 North Wolfe Street
Baltimore, Maryland 21287
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Beverly Hills, California 90211
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Bloomfield, New Jersey 07003
?
mi
from
Bloomfield, NJ
Click here to add this to my saved trials
Boston, Massachusetts 02114
?
mi
from
Boston, MA
Click here to add this to my saved trials
6035 Fairview Road
Charlotte, North Carolina 28210
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
8 Ranoldo Terrace
Cherry Hill, New Jersey 08034
?
mi
from
Cherry Hill, NJ
Click here to add this to my saved trials
1815 Clarkson Road
Chesterfield, Missouri 63017
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
226 South Woods Mill Road
Chesterfield, Missouri 63017
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
Chevy Chase, Maryland 20815
?
mi
from
Chevy Chase, MD
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45242
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
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...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Durango, Colorado 81301
?
mi
from
Durango, CO
Click here to add this to my saved trials
7760 France Avenue South
Edina, Minnesota 55435
?
mi
from
Edina, MN
Click here to add this to my saved trials
Edmond, Oklahoma 73013
?
mi
from
Edmond, OK
Click here to add this to my saved trials
Encino, California 91436
?
mi
from
Encino, CA
Click here to add this to my saved trials
Florence, South Carolina 29501
?
mi
from
Florence, SC
Click here to add this to my saved trials
1725 East Prospect Road
Fort Collins, Colorado 80525
?
mi
from
Fort Collins, CO
Click here to add this to my saved trials
Fort Myers, Florida 33907
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
Fort Myers, Florida 33912
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
1101 6th Avenue
Fort Worth, Texas 76104
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Fullerton, California 92835
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
1432 Kimbrough Road
Germantown, Tennessee 38138
?
mi
from
Germantown, TN
Click here to add this to my saved trials
Golden, Colorado 80401
?
mi
from
Golden, CO
Click here to add this to my saved trials
Grand Rapids, Michigan 45946
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
Grand Rapids, Michigan 49546
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
200 Motor Parkway
Hauppauge, New York 11788
?
mi
from
Hauppauge, NY
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Joliet, Illinois 60435
?
mi
from
Joliet, IL
Click here to add this to my saved trials
9415 Campus Point Drive
La Jolla, California 92093
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Lexington, Kentucky 40509
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Los Angeles, California
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Marietta, Georgia 30060
?
mi
from
Marietta, GA
Click here to add this to my saved trials
McAllen, Texas 78503
?
mi
from
McAllen, TX
Click here to add this to my saved trials
502 East New Haven Avenue
Melbourne, Florida 32901
?
mi
from
Melbourne, FL
Click here to add this to my saved trials
2485 Hospital Drive
Mountain View, California 94040
?
mi
from
Mountain View, CA
Click here to add this to my saved trials
Nashville, Tennessee 37203
?
mi
from
Nashville, TN
Click here to add this to my saved trials
460 Park Avenue
New York, New York 10022
?
mi
from
New York, NY
Click here to add this to my saved trials
1800 Republic Road
Norfolk, Virginia 23451
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
?
mi
from
Oak Forest, IL
Click here to add this to my saved trials
Paducah, Kentucky 42001
?
mi
from
Paducah, KY
Click here to add this to my saved trials
Palm Beach Gardens, Florida 33410
?
mi
from
Palm Beach Gardens, FL
Click here to add this to my saved trials
Pensacola, Florida 32503
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
Phoenix, Arizona 85014
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85020
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Plantation, Florida 33324
?
mi
from
Plantation, FL
Click here to add this to my saved trials
Portland, Maine
?
mi
from
Portland, ME
Click here to add this to my saved trials
Portland, Oregon 97210
?
mi
from
Portland, OR
Click here to add this to my saved trials
3303 Southwest Bond Avenue
Portland, Oregon 97239
?
mi
from
Portland, OR
Click here to add this to my saved trials
Poway, California 92064
?
mi
from
Poway, CA
Click here to add this to my saved trials
Redlands, California 92374
?
mi
from
Redlands, CA
Click here to add this to my saved trials
Reno, Nevada 89502
?
mi
from
Reno, NV
Click here to add this to my saved trials
Richmond, Virginia
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Rockville Centre, New York 11570
?
mi
from
Rockville Centre, NY
Click here to add this to my saved trials
Sacramento, California 95819
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
4344 Central Avenue North
Saint Petersburg, Florida 33711
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
Salt Lake City, Utah
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Salt Lake City, Utah 84107
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
9157 Huebner Road
San Antonio, Texas 78240
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Francisco, California 94107
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
400 Parnassus Avenue
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Santa Ana, California 92705
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Santa Barbara, California 93103
?
mi
from
Santa Barbara, CA
Click here to add this to my saved trials
Shawnee Mission, Kansas 66204
?
mi
from
Shawnee Mission, KS
Click here to add this to my saved trials
9800 Levin Road Northwest
Silverdale, Washington 98383
?
mi
from
Silverdale, WA
Click here to add this to my saved trials
SLingerlands, New York 12159
?
mi
from
SLingerlands, NY
Click here to add this to my saved trials
Spokane, Washington 99204
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Sun City, Arizona 85351
?
mi
from
Sun City, AZ
Click here to add this to my saved trials
3107 East Genesee Street
Syracuse, New York 13224
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
2439 Care Drive
Tallahassee, Florida 32308
?
mi
from
Tallahassee, FL
Click here to add this to my saved trials
Tampa, Florida 33609
?
mi
from
Tampa, FL
Click here to add this to my saved trials
628 Cedar Lane
Teaneck, New Jersey 07666
?
mi
from
Teaneck, NJ
Click here to add this to my saved trials
The Woodlands, Texas 77384
?
mi
from
The Woodlands, TX
Click here to add this to my saved trials
Towson, Maryland 21204
?
mi
from
Towson, MD
Click here to add this to my saved trials
Walnut Creek, California 94598
?
mi
from
Walnut Creek, CA
Click here to add this to my saved trials
Waterford, Connecticut 06385
?
mi
from
Waterford, CT
Click here to add this to my saved trials
West Des Moines, Iowa 50266
?
mi
from
West Des Moines, IA
Click here to add this to my saved trials
Worcester, Massachusetts 01605
?
mi
from
Worcester, MA
Click here to add this to my saved trials