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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Trial Summary
Trial Overview
Inclusion Criteria

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
33
sites
NJ Retina
New Brunswick, New Jersey 08901
Principal Investigator: Daniel B Roth, MD
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Cleveland Clinic
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Rishi Singh, MD
Phone: 216-445-9497
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University of Michigan/Kellogg Eye Center
Ann Arbor, Michigan 48105
Principal Investigator: Grant Comer, MD
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Ann Arbor, MI
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Western Carolina Retinal Associates
Asheville, North Carolina 28803
Principal Investigator: William Z Bridges, Jr, MD
Phone: 828-255-8008
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Asheville, NC
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Southeast Retina Center, P.C.
Augusta, Georgia 30909
Principal Investigator: Dennis M. Marcus, MD
Phone: 706-650-0061
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Augusta, GA
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Soroka Medical Center
Beer Sheva,
Principal Investigator: Itamar Klemperer, M.D.
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Retina-Vitreous Associates Medical Group
Beverly Hills, California 90211
Principal Investigator: David Boyer, MD
Phone: 310-854-6201
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Beverly Hills, CA
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Retina Center of New Jersey, LLC
Bloomfield, New Jersey 07003
Principal Investigator: Patrick Higgins, MD
Phone: 973-707-5632
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Bloomfield, NJ
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Ophthalmic Consultants of Boston
Boston, Massachusetts 02114
Principal Investigator: Jeffrey S. Heier, MD
Phone: 617-367-4800
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Boston, MA
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Lifelong Vision Foundation
Chesterfield, Missouri 63017
Principal Investigator: Nancy Holekamp, MD
Phone: 636-728-0111
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Chesterfield, MO
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Retina Group of Washington
Chevy Chase, Maryland 20815
Principal Investigator: Michael M. Lai, MD
Phone: 301-656-8100
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Palmetto Retina Center, LLC
Florence, South Carolina 29501
Principal Investigator: W. Lloyd Clark, MD
Phone: 803-931-0077
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Florence, SC
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Retina Health Center
Ft. Myers, Florida 33907
Principal Investigator: Alexander M Eaton, MD
Phone: 239-337-3337
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Ft. Myers, FL
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National Ophthalmic Research Institute
Ft. Myers, Florida
Principal Investigator: Paul A Raskauskas, MD
Phone: 239-938-1284
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Ft. Myers, FL
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Colorado Retina Associates
Golden, Colorado 80401
Principal Investigator: Brian Joondeph, MD
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Golden, CO
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Cumberland Valley Retina Consultants
Hagerstown, Maryland 21740
Principal Investigator: Allen Y. Hu, MD
Phone: 310-467-4592
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University of California, Irvine, The Gavin Herbert Eye Institute
Irvine, California 92697
Principal Investigator: Baruch D. Kuppermann, MD, PhD
Phone: 949-824-6256
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Irvine, CA
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Illinois Retina Associates, S.C.
Joliet, Illinois 60435
Principal Investigator: John S. Pollack, MD
Phone: 815-744-7515
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Joliet, IL
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Jacobs Retina Center at UCSD
La Jolla, California 92093
Principal Investigator: William R. Freeman, MD
Phone: 858-822-3170
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La Jolla, CA
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Retina Associates of Kentucky
Lexington, Kentucky 40509
Principal Investigator: Thomas W Stone, MD
Phone: 859-263-3900
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Lexington, KY
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Georgina Retina, P.C.
Marietta, Georgia 30060
Principal Investigator: Robert Stoltz, MD, PhD
Phone: 404-299-5209
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Marietta, GA
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Valley Retina Institute, P.A.
McAllen, Texas 78503
Principal Investigator: Victor H. Gonzalez, MD
Phone: 956-631-8875
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Medical College of Wisconsin
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: David Weinberg, MD
Phone: 414-456-7840
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Illinois Retina Associates
Oak Park, Illinois 60304
Principal Investigator: Mathew W MacCumber, MD, PhD
Phone: 773-871-8444
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Oak Park, IL
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Mid-Atlantic Retina
Philadelphia, Pennsylvania 19107
Principal Investigator: Allen Ho, MD
Phone: 215-928-3095
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Philadelphia, PA
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Associated Retina Consultants
Phoenix, Arizona 85020
Principal Investigator: Alan Gordon, MD
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Phoenix, AZ
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Retina Northwest, PC
Portland, Oregon 97210
Principal Investigator: Michael S Lee, MD
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Portland, OR
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Black Hills Regional Eye Institute
Rapid City, South Dakota 57701
Principal Investigator: Prema Abraham, MD
Phone: 605-341-2000
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Sierra Eye Associates
Reno, Nevada 89502
Principal Investigator: Arshad Khanani, MD
Phone: 775-329-0286
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William Beaumont Hospital-Ophthalmology Research
Royal Oak, Michigan 48073
Principal Investigator: George A. Williams, MD
Phone: 248-551-2175
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Royal Oak, MI
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Medical Center Ophthalmology Associates
San Antonio, Texas 78240
Principal Investigator: Michael A Singer, MD
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Wake Forest Baptist Health Eye Center
Winston-Salem, North Carolina 27157
Principal Investigator: Craig Greven, MD
Phone: 336-716-4091
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Center for Retina and Macular Disease
Winter Haven, Florida 33880
Principal Investigator: Michael Tolentino, MD
Phone: 863-297-5400
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