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)
- Conditions
- Macular Degeneration
- Interventions
- Drug: NT-503-3 ECT implantation
- Registration Number
- NCT02228304
- Lead Sponsor
- Neurotech Pharmaceuticals
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 42
- Diagnosis of Active (recurrent or persistent) subfoveal CNV lesions secondary to AMD in the study eye
- Prior Intravitreal Anti-VEGF injections
Key
- Significant subretinal hemorrhage
- Significant Scar and/or, fibrosis
- Suspected polypoidal choroidopathy, or pigment epithelial tears or rips
- Inadequate response to anti-VEGF therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NT-503-3 ECT implantation NT-503-3 ECT implantation - Eylea® injected intravitreally every 8 weeks Eylea® injected intravitreally administered every 8 weeks Eylea® injected intravitreally every 8 weeks
- Primary Outcome Measures
Name Time Method Percentage of patients with less than a 3-line loss of BCVA in ETDRS letters Week 52 and Week 108
- Secondary Outcome Measures
Name Time Method Change from baseline in best corrected visual acuity (BCVA) Week 52 Mean (median) number of Eylea® injections and number of patients requiring Eylea® injections for rescue therapy Up to Week 108 Change from baseline in macular thickness as determined by Spectral Domain Optical Coherence Tomography (sdOCT) Up to Week 108
Trial Locations
- Locations (38)
Georgina Retina, P.C.
🇺🇸Marietta, Georgia, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Illinois Retina Associates
🇺🇸Oak Park, Illinois, United States
NJ Retina
🇺🇸New Brunswick, New Jersey, United States
Ophthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
Meir Medical Center
🇮🇱Kfar Saba, Israel
National Ophthalmic Research Institute
🇺🇸Fort Myers, Florida, United States
Center for Retina and Macular Disease
🇺🇸Winter Haven, Florida, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
Cumberland Valley Retina Consultants, PC
🇺🇸Hagerstown, Maryland, United States
William Beaumont Hospital-Ophthalmology Research
🇺🇸Royal Oak, Michigan, United States
Hadassah-Hebrew University Medical Center
🇮🇱Jerusalem, Israel
Kaplan Medical Center
🇮🇱Rehovot, Israel
Palmetto Retina Center, LLC
🇺🇸Florence, South Carolina, United States
Soroka Medical Center
🇮🇱Beer Sheva, Israel
The Retina Group of Washington
🇺🇸Chevy Chase, Maryland, United States
Black Hills Regional Eye Institute
🇺🇸Rapid City, South Dakota, United States
Rabin Medical Center
🇮🇱Petach-tikva, Israel
Sourasky Medical Center,
🇮🇱Tel-Aviv, Israel
Jacobs Retina Center at UCSD
🇺🇸La Jolla, California, United States
Retina-Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
University of California, Irvine, The Gavin Herbert Eye Institute
🇺🇸Irvine, California, United States
Colorado Retina Associates
🇺🇸Golden, Colorado, United States
Southeast Retina Center, PC
🇺🇸Augusta, Georgia, United States
Retina Health Center
🇺🇸Fort Myers, Florida, United States
Retina Associates of Kentucky
🇺🇸Lexington, Kentucky, United States
Illinois Retina Associates, S.C.
🇺🇸Joliet, Illinois, United States
Lifelong Vision Foundation
🇺🇸Chesterfield, Missouri, United States
Western Carolina Retinal Associates
🇺🇸Asheville, North Carolina, United States
Retina Center of New Jersey, LLC
🇺🇸Bloomfield, New Jersey, United States
Mid Atlantic Retina
🇺🇸Philadelphia, Pennsylvania, United States
Wake Forest Baptist Health Eye Center
🇺🇸Winston-Salem, North Carolina, United States
Valley Retina Institute, PA
🇺🇸McAllen, Texas, United States
Associated Retina Consultants, Ltd.
🇺🇸Phoenix, Arizona, United States
Medical Center Ophthalmology Associates
🇺🇸San Antonio, Texas, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Michigan, Kellogg Eye Center
🇺🇸Ann Arbor, Michigan, United States
Retina Northwest, PC
🇺🇸Portland, Oregon, United States