Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel)
NCT ID: NCT03071965
Last Updated: 2025-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2017-05-12
2021-05-11
Brief Summary
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A substudy was conducted in which subjects enrolled in study (NTMT-02), who had 1 study-eligible eye that underwent sham surgery, were offered the option to have NT-501 implanted in the same study eye. Of the 19 subjects who had 1 study-eligible eye and underwent sham surgery in the Cohort 2 precursor study (NTMT-02), 16 subjects elected to have NT-501 implanted in the same study eye during the substudy
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cohort 1
Participants completed protocol NTMT-01. All participants received surgery to implant NT-501. All participants received ciliary neurotrophic factor (CNTF).
Ciliary neurotrophic factor (CNTF)
The investigational product is the NT-501 encapsulated cell system, which consists of cells encapsulated within a semi-permeable polymer membrane and supportive matrices. NT-501 contains NTC-201 cells that secrete recombinant human CNTF, which were derived from genetically modified NTC-200 cells.
Surgery
Surgery to implant device for NT-501
Cohort 2
Participants completed protocol NTMT-02. Participants for cohort 2 arm were either:
* NT-501 group: included subjects who each had 1 study-eligible eye that had NT-501 implanted and a fellow eye that did not undergo any study intervention.
* Sham group: included subjects who each had 1 study-eligible eye that underwent sham surgery and a fellow eye that did not undergo any study intervention.
* Sham+NT-501 group: included subjects who had both eyes that were study-eligible, and had NT-501 implanted in 1 eye and underwent sham surgery in the contralateral eye.
Ciliary neurotrophic factor (CNTF)
The investigational product is the NT-501 encapsulated cell system, which consists of cells encapsulated within a semi-permeable polymer membrane and supportive matrices. NT-501 contains NTC-201 cells that secrete recombinant human CNTF, which were derived from genetically modified NTC-200 cells.
Surgery
Surgery to implant device for NT-501
Surgery
Sham surgery
Interventions
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Ciliary neurotrophic factor (CNTF)
The investigational product is the NT-501 encapsulated cell system, which consists of cells encapsulated within a semi-permeable polymer membrane and supportive matrices. NT-501 contains NTC-201 cells that secrete recombinant human CNTF, which were derived from genetically modified NTC-200 cells.
Surgery
Surgery to implant device for NT-501
Surgery
Sham surgery
Eligibility Criteria
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Inclusion Criteria
* Participant must be offered sufficient opportunity to review and to understand the informed consent form, agree to the form's contents, and provide written informed consent.
21 Years
80 Years
ALL
No
Sponsors
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Neurotech Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Aaberg, Jr, MD
Role: STUDY_CHAIR
Neurotech Pharmaceuticals, LLC
Locations
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Stein Eye Institute / David Geffen School of Medicine
Los Angeles, California, United States
University of Miami-Miller School of Medicine, Bascom Palmer Eye Institute
Miami, Florida, United States
Emory University School of Medicine, Dept of Ophthalmology, Emory University Eye Center
Atlanta, Georgia, United States
NIH Clinical Center
Rockville, Maryland, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
University of Michigan, Kellogg Eye Center
Ann Arbor, Michigan, United States
Retina Associates of Cleveland, Inc
Cleveland, Ohio, United States
University of Wisconsin-Madison, Department of Ophthalmology and Visual Sciences
Madison, Wisconsin, United States
Sydney Eye Hospital
Sydney, New South Wales, Australia
Centre for Eye Research Australia
East Melbourne, Victoria, Australia
Lions Eye Institute
Nedlands, Western Australia, Australia
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NTMT-01/02E
Identifier Type: -
Identifier Source: org_study_id
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