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 |
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
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
San Antonio, Texas 78240
Principal Investigator: Michael A Singer, MD
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Rishi Singh, MD
Phone: 216-445-9497
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
Click here to add this to my saved trials
Ann Arbor, Michigan 48105
Principal Investigator: Grant Comer, MD
Click here to add this to my saved trials
Asheville, North Carolina 28803
Principal Investigator: William Z Bridges, Jr, MD
Phone: 828-255-8008
Click here to add this to my saved trials
Augusta, Georgia 30909
Principal Investigator: Dennis M. Marcus, MD
Phone: 706-650-0061
Click here to add this to my saved trials
Click here to add this to my saved trials
Beverly Hills, California 90211
Principal Investigator: David Boyer, MD
Phone: 310-854-6201
Click here to add this to my saved trials
Bloomfield, New Jersey 07003
Principal Investigator: Patrick Higgins, MD
Phone: 973-707-5632
Click here to add this to my saved trials
Boston, Massachusetts 02114
Principal Investigator: Jeffrey S. Heier, MD
Phone: 617-367-4800
Click here to add this to my saved trials
Chesterfield, Missouri 63017
Principal Investigator: Nancy Holekamp, MD
Phone: 636-728-0111
Click here to add this to my saved trials
Chevy Chase, Maryland 20815
Principal Investigator: Michael M. Lai, MD
Phone: 301-656-8100
Click here to add this to my saved trials
Florence, South Carolina 29501
Principal Investigator: W. Lloyd Clark, MD
Phone: 803-931-0077
Click here to add this to my saved trials
Ft. Myers, Florida 33907
Principal Investigator: Alexander M Eaton, MD
Phone: 239-337-3337
Click here to add this to my saved trials
Ft. Myers, Florida
Principal Investigator: Paul A Raskauskas, MD
Phone: 239-938-1284
Click here to add this to my saved trials
Click here to add this to my saved trials
Hagerstown, Maryland 21740
Principal Investigator: Allen Y. Hu, MD
Phone: 310-467-4592
Click here to add this to my saved trials
Irvine, California 92697
Principal Investigator: Baruch D. Kuppermann, MD, PhD
Phone: 949-824-6256
Click here to add this to my saved trials
Joliet, Illinois 60435
Principal Investigator: John S. Pollack, MD
Phone: 815-744-7515
Click here to add this to my saved trials
La Jolla, California 92093
Principal Investigator: William R. Freeman, MD
Phone: 858-822-3170
Click here to add this to my saved trials
Lexington, Kentucky 40509
Principal Investigator: Thomas W Stone, MD
Phone: 859-263-3900
Click here to add this to my saved trials
Marietta, Georgia 30060
Principal Investigator: Robert Stoltz, MD, PhD
Phone: 404-299-5209
Click here to add this to my saved trials
McAllen, Texas 78503
Principal Investigator: Victor H. Gonzalez, MD
Phone: 956-631-8875
Click here to add this to my saved trials
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: David Weinberg, MD
Phone: 414-456-7840
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
Click here to add this to my saved trials
Click here to add this to my saved trials
Oak Park, Illinois 60304
Principal Investigator: Mathew W MacCumber, MD, PhD
Phone: 773-871-8444
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19107
Principal Investigator: Allen Ho, MD
Phone: 215-928-3095
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Rapid City, South Dakota 57701
Principal Investigator: Prema Abraham, MD
Phone: 605-341-2000
Click here to add this to my saved trials
Reno, Nevada 89502
Principal Investigator: Arshad Khanani, MD
Phone: 775-329-0286
Click here to add this to my saved trials
Royal Oak, Michigan 48073
Principal Investigator: George A. Williams, MD
Phone: 248-551-2175
Click here to add this to my saved trials
Winston-Salem, North Carolina 27157
Principal Investigator: Craig Greven, MD
Phone: 336-716-4091
Click here to add this to my saved trials
Winter Haven, Florida 33880
Principal Investigator: Michael Tolentino, MD
Phone: 863-297-5400
Click here to add this to my saved trials