Study of the Efficacy and Safety of the Ranibizumab Port Delivery System (RPDS) for Sustained Delivery of Ranibizumab in Participants With Subfoveal Neovascular Age-Related Macular Degeneration (AMD) (LADDER)



Status:Active, not recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:3/10/2019
Start Date:September 28, 2015
End Date:March 27, 2019

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A Phase II, Multicenter, Randomized, Active Treatment-Controlled Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration

This is a Phase II clinical study to evaluate the efficacy, safety and pharmacokinetics of
three different formulations of ranibizumab delivered via RPDS implant compared with the
standard of care (SOC) intravitreal (ITV) injections of ranibizumab, in participants with
subfoveal neovascular AMD.


Inclusion Criteria:

- Newly diagnosed with wet AMD within 9 months of screening visit

- Participant must have received at least 2 prior ITV anti-vascular endothelial growth
factor (VEGF) injections. However, the most recent anti-VEGF injection must have been
ranibizumab and must have occurred at least 7 days prior to the screening visit

- Demonstrated response to prior ITV anti-VEGF treatment

- Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study
(ETDRS) charts of 20/20-20/200 Snellen equivalent

Exclusion Criteria:

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

- Study eye treatment with ITV anti-VEGF agents other than ranibizumab within 1 month
prior to the randomization visit

- History of laser photocoagulation, Visudyne®, ITV corticosteroid injection, vitrectomy
surgery, submacular surgery, device implantation, or other surgical intervention for
AMD in the study eye

- Prior participation in a clinical trial involving anti-angiogenic drugs, other than
ranibizumab, in either eye within 2 months of the randomization visit

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

- Subfoveal fibrosis, or atrophy in the study eye

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

- Uncontrolled ocular hypertension or glaucoma in the study eye

- History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
in the study eye

- Uncontrolled blood pressure

- Uncontrolled atrial fibrillation within 3 months of informed consent

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

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

- Use of oral corticosteroids

- Current treatment for any active systemic infection

- Use of anticoagulants, anti-platelets (other than aspirin), or medications known to
exert similar effects

- Active malignancy within 12 months of randomization

- History of allergy to fluorescein

- 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
62
sites
Phoenix, Arizona 85014
1113
mi
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Phoenix, AZ
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5441 Health Center Drive
Abilene, Texas 79606
1579
mi
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Abilene, TX
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Albuquerque, New Mexico 87109
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mi
from 98109
Albuquerque, NM
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1 University of New Mexico
Albuquerque, New Mexico 87131
1185
mi
from 98109
Albuquerque, NM
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Arlington, Texas 76012
1667
mi
from 98109
Arlington, TX
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Atlanta, Georgia 30322
2180
mi
from 98109
Atlanta, GA
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Augusta, Georgia 30909
2300
mi
from 98109
Augusta, GA
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Aurora, Colorado 80045
1026
mi
from 98109
Aurora, CO
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Austin, Texas 78705
1769
mi
from 98109
Austin, TX
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Bakersfield, California 93309
865
mi
from 98109
Bakersfield, CA
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600 North Wolfe Street
Baltimore, Maryland 21287
2329
mi
from 98109
Baltimore, MD
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Bloomfield, New Jersey 07003
2390
mi
from 98109
Bloomfield, NJ
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1717 Woolbright Road
Boynton Beach, Florida 33426
2701
mi
from 98109
Boynton Beach, FL
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6035 Fairview Road
Charlotte, North Carolina 28210
2284
mi
from 98109
Charlotte, NC
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8 Ranoldo Terrace
Cherry Hill, New Jersey 08034
2382
mi
from 98109
Cherry Hill, NJ
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1815 Clarkson Road
Chesterfield, Missouri 63017
1703
mi
from 98109
Chesterfield, MO
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Chevy Chase, Maryland 20815
2317
mi
from 98109
Chevy Chase, MD
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Cincinnati, Ohio 45242
1967
mi
from 98109
Cincinnati, OH
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Cleveland, Ohio 44122
2029
mi
from 98109
Cleveland, 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
mi
from 98109
Cleveland, OH
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2770 North Union Boulevard
Colorado Springs, Colorado 80909
1066
mi
from 98109
Colorado Springs, CO
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7760 France Avenue South
Edina, Minnesota 55435
1390
mi
from 98109
Edina, MN
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Encino, California 91436
952
mi
from 98109
Encino, CA
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Florence, South Carolina 29501
2372
mi
from 98109
Florence, SC
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Fort Lauderdale, Florida 33334
2714
mi
from 98109
Fort Lauderdale, FL
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Fort Myers, Florida 33912
2624
mi
from 98109
Fort Myers, FL
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1432 Kimbrough Road
Germantown, Tennessee 38138
1877
mi
from 98109
Germantown, TN
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Golden, Colorado 80401
1010
mi
from 98109
Golden, CO
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Grand Rapids, Michigan 45946
1793
mi
from 98109
Grand Rapids, MI
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Grand Rapids, Michigan 49546
1802
mi
from 98109
Grand Rapids, MI
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Houston, Texas 77030
1892
mi
from 98109
Houston, TX
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Joliet, Illinois 60435
1720
mi
from 98109
Joliet, IL
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9415 Campus Point Drive
La Jolla, California 92093
1053
mi
from 98109
La Jolla, CA
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Lexington, Kentucky 40509
2010
mi
from 98109
Lexington, KY
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Los Angeles, California
962
mi
from 98109
Los Angeles, CA
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2485 Hospital Drive
Mountain View, California 94040
709
mi
from 98109
Mountain View, CA
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Nashville, Tennessee 37203
1971
mi
from 98109
Nashville, TN
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New York, New York 10021
2402
mi
from 98109
New York, NY
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1800 Republic Road
Norfolk, Virginia 23451
2442
mi
from 98109
Norfolk, VA
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Paducah, Kentucky 42001
1852
mi
from 98109
Paducah, KY
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Pensacola, Florida 32503
2200
mi
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Pensacola, FL
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Phoenix, Arizona 85020
1116
mi
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Phoenix, AZ
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203 Lothrop Street
Pittsburgh, Pennsylvania 15213
2134
mi
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Pittsburgh, PA
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Portland, Oregon 97210
147
mi
from 98109
Portland, OR
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3303 Southwest Bond Avenue
Portland, Oregon 97239
148
mi
from 98109
Portland, OR
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Reno, Nevada 89502
578
mi
from 98109
Reno, NV
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160 Sawgrass Drive
Rochester, New York 14620
2162
mi
from 98109
Rochester, NY
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Sacramento, California 95819
627
mi
from 98109
Sacramento, CA
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4344 Central Avenue North
Saint Petersburg, Florida 33711
2525
mi
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Saint Petersburg, FL
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Salt Lake City, Utah
701
mi
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Salt Lake City, UT
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9157 Huebner Road
San Antonio, Texas 78240
1777
mi
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San Antonio, TX
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San Francisco, California 94107
681
mi
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San Francisco, CA
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400 Parnassus Avenue
San Francisco, California 94143
681
mi
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San Francisco, CA
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Santa Ana, California 92705
987
mi
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Santa Ana, CA
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Santa Barbara, California 93103
922
mi
from 98109
Santa Barbara, CA
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Sun City, Arizona 85351
1102
mi
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Sun City, AZ
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Tampa, Florida 33609
2525
mi
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Tampa, FL
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Towson, Maryland 21204
2325
mi
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Towson, MD
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Ventura, California 93003
936
mi
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Ventura, CA
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West Des Moines, Iowa 50266
1457
mi
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West Des Moines, IA
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West Mifflin, Pennsylvania 15122
2139
mi
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West Mifflin, PA
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Worcester, Massachusetts 01605
2454
mi
from 98109
Worcester, MA
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