- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02228304
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)
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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-
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Beer Sheva, Israel
- Soroka Medical Center
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Jerusalem, Israel, 91120
- Hadassah-Hebrew University Medical Center
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Kfar Saba, Israel, 44281
- Meir Medical Center
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Petach-tikva, Israel, 49100
- Rabin Medical Center
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Rehovot, Israel, 76100
- Kaplan Medical Center
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Tel-Aviv, Israel, 64239
- Sourasky Medical Center,
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Arizona
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Phoenix, Arizona, United States, 85020
- Associated Retina Consultants, Ltd.
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California
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Beverly Hills, California, United States, 90211
- Retina-Vitreous Associates Medical Group
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Irvine, California, United States, 92697
- University of California, Irvine, The Gavin Herbert Eye Institute
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La Jolla, California, United States, 92093
- Jacobs Retina Center at UCSD
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Colorado
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Golden, Colorado, United States, 80401
- Colorado Retina Associates
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Florida
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Fort Myers, Florida, United States, 33912
- National Ophthalmic Research Institute
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Fort Myers, Florida, United States, 33907
- Retina Health Center
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Winter Haven, Florida, United States, 33880
- Center for Retina and Macular Disease
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Georgia
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Augusta, Georgia, United States, 30909
- Southeast Retina Center, PC
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Marietta, Georgia, United States, 30060
- Georgina Retina, P.C.
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Illinois
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Joliet, Illinois, United States, 60435
- Illinois Retina Associates, S.C.
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Oak Park, Illinois, United States, 60304
- Illinois Retina Associates
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Kentucky
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Lexington, Kentucky, United States, 40509
- Retina Associates of Kentucky
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Maryland
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Chevy Chase, Maryland, United States, 20815
- The Retina Group of Washington
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Hagerstown, Maryland, United States, 21740
- Cumberland Valley Retina Consultants, PC
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Ophthalmic Consultants of Boston
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Michigan
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Ann Arbor, Michigan, United States, 48105
- University of Michigan, Kellogg Eye Center
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Royal Oak, Michigan, United States, 48073
- William Beaumont Hospital-Ophthalmology Research
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Missouri
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Chesterfield, Missouri, United States, 63017
- Lifelong Vision Foundation
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Nevada
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Reno, Nevada, United States, 89502
- Sierra Eye Associates
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New Jersey
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Bloomfield, New Jersey, United States, 07003
- Retina Center of New Jersey, LLC
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New Brunswick, New Jersey, United States, 08901
- NJ Retina
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North Carolina
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Asheville, North Carolina, United States, 28803
- Western Carolina Retinal Associates
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Health Eye Center
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Oregon
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Portland, Oregon, United States, 97210
- Retina Northwest, PC
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Mid Atlantic Retina
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South Carolina
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Florence, South Carolina, United States, 29501
- Palmetto Retina Center, LLC
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South Dakota
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Rapid City, South Dakota, United States, 57701
- Black Hills Regional Eye Institute
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Texas
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McAllen, Texas, United States, 78503
- Valley Retina Institute, PA
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San Antonio, Texas, United States, 78240
- Medical Center Ophthalmology Associates
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NT-503-3 ECT implantation
|
NT-503-3 ECT implantation is a biological sustained drug delivery device that could provide continuous delivery of an anti-VEGF therapy
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Active Comparator: Eylea® injected intravitreally every 8 weeks
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The first part, stage 1, Phase I is open label with the experimental treatment arm only.
Eylea® injected intravitreally is only used as a comparator in the stage 2, Phase II, portion of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of patients with less than a 3-line loss of BCVA in ETDRS letters
Time Frame: Week 52 and Week 108
|
Week 52 and Week 108
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in best corrected visual acuity (BCVA)
Time Frame: Week 52
|
Week 52
|
Change from baseline in macular thickness as determined by Spectral Domain Optical Coherence Tomography (sdOCT)
Time Frame: Up to Week 108
|
Up to Week 108
|
Mean (median) number of Eylea® injections and number of patients requiring Eylea® injections for rescue therapy
Time Frame: Up to Week 108
|
Up to Week 108
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Charles Johnson, MB, ChB, Neurotech Pharmaceuticals, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NT-503-3-AMD-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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