Study of the Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology (ECT) for the Treatment of Recurrent Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)



Status:Recruiting
Conditions:Cardiology, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:4/21/2016
Start Date:September 2014
End Date:August 2018
Contact:Charles Johnson, MB, ChB
Email:c.johnson@neurotechusa.com
Phone:401.495.2395

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A Multi-Center, Two-Stage, Open-Label Phase I and Randomized, Active Controlled, Masked Phase II Study to Evaluate the Safety and Efficacy of Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology Compared With Eylea for the Treatment of Recurrent CNV Secondary to AMD

Prospective, multi-center 2-stage study. Stage 1 (Phase I) is open-label with all patients
treated with the NT-503-3 ECT implant. Stage 1 (Phase I) patients will undergo explantation
at year 2. Those who, in the opinion of the investigator, are still candidates for continued
anti-VEGF therapy will be re-implanted with a new NT-503-3 investigational product and
followed for an additional 12 weeks before study exit. Stage 2 (Phase II) is a separate,
randomized, masked phase during which eligible patients will be randomized to the NT-503-3
group or the control group.

Clinical Hypotheses:

- NT-503-3 ECT is comparable to Eylea® injected intravitreally every 8 weeks in the
prevention of vision loss due to recurrent CNV secondary to AMD

- NT-503-3 ECT has an acceptable safety profile


Key Inclusion Criteria:

- Diagnosis of Active (recurrent or persistent) subfoveal CNV lesions secondary to AMD
in the study eye

- Prior Intravitreal Anti-VEGF injections

Key Exclusion Criteria:

- Significant subretinal hemorrhage

- Significant Scar and/or, fibrosis

- Suspected polypoidal choroidopathy, or pigment epithelial tears or rips

- Inadequate response to anti-VEGF therapy
We found this trial at
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Florence, South Carolina 29501
Principal Investigator: W. Lloyd Clark, MD
Phone: 803-931-0077
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Rishi Singh, MD
Phone: 216-445-9497
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Ann Arbor, Michigan 48105
Principal Investigator: Grant Comer, MD
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Asheville, North Carolina 28803
Principal Investigator: William Z Bridges, Jr, MD
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Augusta, Georgia 30909
Principal Investigator: Dennis M. Marcus, MD
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Beer Sheva,
Principal Investigator: Itamar Klemperer, M.D.
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Beverly Hills, California 90211
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Bloomfield, New Jersey 07003
Principal Investigator: Patrick Higgins, MD
Phone: 973-707-5632
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Boston, Massachusetts 02114
Principal Investigator: Jeffrey S. Heier, MD
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Chesterfield, Missouri 63017
Principal Investigator: Nancy Holekamp, MD
Phone: 636-728-0111
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Chevy Chase, Maryland 20815
Principal Investigator: Michael M. Lai, MD
Phone: 301-656-8100
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Ft. Myers, Florida 33907
Principal Investigator: Alexander M Eaton, MD
Phone: 239-337-3337
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Ft. Myers, Florida
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Golden, Colorado 80401
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Hagerstown, Maryland 21740
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Irvine, California 92697
Principal Investigator: Baruch D. Kuppermann, MD, PhD
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Joliet, Illinois 60435
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La Jolla, California 92093
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Lexington, Kentucky 40509
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Marietta, Georgia 30060
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McAllen, Texas 78503
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: David Weinberg, MD
Phone: 414-456-7840
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New Brunswick, New Jersey 08901
Principal Investigator: Daniel B Roth, MD
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Oak Park, Illinois 60304
Principal Investigator: Mathew W MacCumber, MD, PhD
Phone: 773-871-8444
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Philadelphia, Pennsylvania 19107
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Phoenix, Arizona 85020
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Portland, Oregon 97210
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Rapid City, South Dakota 57701
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Royal Oak, Michigan 48073
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San Antonio, Texas 78240
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Winston-Salem, North Carolina 27157
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Winter Haven, Florida 33880
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