Phase 4 Study: Long-term Safety and Efficacy of NT-501 in MacTel Type 2, Including Sham Procedure Participants
Sponsor: Neurotech Pharmaceuticals • ClinicalTrials.gov ID: NCT06971939
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The purpose of this global, multicenter, open-label, Phase 4 clinical extension study is to evaluate the long-term safety and efficacy of revakinagene taroretcel-lwey (Encelto™; hereinafter referred to as NT-501), in participants with macular telangiectasia type 2 (MacTel) who previously received the intraocular implant in a Phase 1, Phase 2, or Phase 3 clinical study and have retained at least 1 NT-501 at study entry. In addition, this study will evaluate the safety and efficacy of NT501 in participants who previously underwent the sham procedure in a Phase 3 MacTel clinical study and elect to have NT-501 implanted intraocularly in this Phase 4 study.
Interventions
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NT-501/revakinagene taroretcel-lwey
(Combination product)
NT-501 is surgically implanted into the vitreous cavity to continuously release recombinant human ciliary neurotrophic factor (CNTF).
Eligibility criteria
Conditions
Locations
- Scripps Health — La Jolla, California, United States
- Jules Stein Eye Institute/UCLA — Los Angeles, California, United States
- Stanford University School of Medicine — Palo Alto, California, United States
- Bay Area Retina Associates — Walnut Creek, California, United States
- Colorado Retina — Lakewood, Colorado, United States
- Bascom Palmer — Miami, Florida, United States
- Emory Eye Center — Atlanta, Georgia, United States
- Northwestern University — Chicago, Illinois, United States
- National Eye Institute — Bethesda, Maryland, United States
- Cumberland Valley Retina Consultants — Frederick, Maryland, United States
- Massachusetts Eye and Ear Infirmary, Retina Service — Boston, Massachusetts, United States
- Foundation for Vision Research — Grand Rapids, Michigan, United States
- Retina Consultants of Minnesota — Minneapolis, Minnesota, United States
- Envision Ocular, LLC — Bloomfield, New Jersey, United States
- Cincinnati Eye Institute — Cincinnati, Ohio, United States
- Retina Associates of Cleveland, Inc. — Cleveland, Ohio, United States
- Retina Northwest, P.C. — Portland, Oregon, United States
- Scheie Eye Institute — Philadelphia, Pennsylvania, United States
- Southeastern Retina Associates, P.C. — Knoxville, Tennessee, United States
- Texas Retina Associates — Dallas, Texas, United States
- Retina Center of Texas — Dallas, Texas, United States
- Retina Consultants of Texas — Houston, Texas, United States
- University of Utah John A. Moran Center — Salt Lake City, Utah, United States
- Cerulea — East Melbourne, Australia
- Lion's Eye Institute — Perth, Australia
- Sydney Eye Hospital — Sydney, Australia
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Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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