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
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5441 Health Center Drive
Abilene, Texas 79606
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Albuquerque, New Mexico 87109
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Albuquerque, New Mexico 87131
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Arlington, Texas 76012
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Atlanta, Georgia 30322
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Austin, Texas 78705
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Bakersfield, California 93309
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600 North Wolfe Street
Baltimore, Maryland 21287
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Bloomfield, New Jersey 07003
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1717 Woolbright Road
Boynton Beach, Florida 33426
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6035 Fairview Road
Charlotte, North Carolina 28210
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8 Ranoldo Terrace
Cherry Hill, New Jersey 08034
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1815 Clarkson Road
Chesterfield, Missouri 63017
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Chevy Chase, Maryland 20815
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Cincinnati, Ohio 45242
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Cleveland, Ohio 44122
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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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2770 North Union Boulevard
Colorado Springs, Colorado 80909
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7760 France Avenue South
Edina, Minnesota 55435
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Encino, California 91436
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Florence, South Carolina 29501
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Fort Lauderdale, Florida 33334
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1432 Kimbrough Road
Germantown, Tennessee 38138
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Golden, Colorado 80401
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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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2485 Hospital Drive
Mountain View, California 94040
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Nashville, Tennessee 37203
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New York, New York 10021
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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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203 Lothrop Street
Pittsburgh, Pennsylvania 15213
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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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San Antonio, Texas 78240
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