- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03071965
Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel)
March 15, 2022 updated by: Neurotech Pharmaceuticals
This study is a prospective, phase 2 extension study of participants previously enrolled in NTMT-01 and NTMT-02.
This study is designed to evaluate long term safety and efficacy of the NT-501 implant in participants previously enrolled in the NTMT-01 and NTMT-02 protocols.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New South Wales
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Sydney, New South Wales, Australia, 2000
- Sydney Eye Hospital
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Victoria
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East Melbourne, Victoria, Australia, 3002
- Centre for Eye Research Australia
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Lions Eye Institute
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California
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Los Angeles, California, United States, 90095
- Stein Eye Institute / David Geffen School of Medicine
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Florida
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Miami, Florida, United States, 33136
- University of Miami-Miller School of Medicine, Bascom Palmer Eye Institute
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University School of Medicine, Dept of Ophthalmology, Emory University Eye Center
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Maryland
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Rockville, Maryland, United States, 20892
- NIH Clinical Center
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts Eye and Ear Infirmary
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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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Ohio
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Cleveland, Ohio, United States, 44122
- Retina Associates of Cleveland, INC
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Wisconsin
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Madison, Wisconsin, United States, 53705
- University of Wisconsin-Madison, Department of Ophthalmology and Visual Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Previously enrolled in the NTMT-01 or NTMT-02 protocol and received the NT-501 implant and/or underwent a Sham procedure
- 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.
Exclusion Criteria:
- There are no Exclusion Criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
Participants completed protocol NTMT-01.
All participants received surgery to implant NT-501.
All participants received ciliary neurotrophic factor (CNTF).
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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 to implant device for NT-501
Sham surgery
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Experimental: Cohort 2
Participants completed protocol NTMT-02.
Participants received surgery to implant NT-501 or sham surgery to mimic implant procedure.
Participants that received NT-501 implant were exposed to 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 to implant device for NT-501
Sham surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ellipsoid zone (area of IS/OS loss)
Time Frame: 36, 48, 60, and 72 months
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Change from baseline to 36, 48, 60, 72 months as measured by SD-OCT for Cohort 2
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36, 48, 60, and 72 months
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Ellipsoid zone (area of IS/OS loss)
Time Frame: 72, 84, 96, and 108 months
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Change from baseline to 72, 84, 96, and 108 months as measured by SD-OCT for Cohort 1
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72, 84, 96, and 108 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Retinal sensitivity (dB)
Time Frame: 36, 48, 60, and 72 months
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Change from baseline to 36, 48, 60, and 72 months as measured by microperimetry for Cohort 2
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36, 48, 60, and 72 months
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Retinal sensitivity (dB)
Time Frame: 72, 84, 96, and 108 months
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Change from baseline to 72, 84, 96, and 108 months as measured by microperimetry for Cohort 1
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72, 84, 96, and 108 months
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Increase in ellipsoid zone (area of IS/OS loss)
Time Frame: 36, 48, 60, and 72 months
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Proportion of study eyes with a 35% or more increase from baseline at 36, 48, 60, and 72 months for Cohort 2
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36, 48, 60, and 72 months
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Increase in ellipsoid zone (area of IS/OS loss)
Time Frame: 72, 84, 96, and 108 months
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Proportion of study eyes with a 35% or more increase from baseline at 72, 84, 96, and 108 months for Cohort 1
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72, 84, 96, and 108 months
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Visual acuity
Time Frame: 36, 48, 60, and 72 months
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Change in best corrected visual acuity from baseline to 36, 48, 60, and 72 months for Cohort 2
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36, 48, 60, and 72 months
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Visual acuity
Time Frame: 72, 84, 96, and 108 months
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Change in best corrected visual acuity from baseline to 72, 84, 96, and 108 months for Cohort 1
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72, 84, 96, and 108 months
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Visual acuity
Time Frame: 36, 48, 60, and 72 months
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Proportion of study eyes with 15 or more letter loss in BCVA from baseline to 36, 48, 60, and 72 months for Cohort 2
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36, 48, 60, and 72 months
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Visual acuity
Time Frame: 72, 84, 96, and 108 months
|
Proportion of study eyes with 15 or more letter loss in BCVA from baseline to 72, 84, 96, and 108 months for Cohort 1
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72, 84, 96, and 108 months
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Visual acuity
Time Frame: 36, 48, 60, and 72 months
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Proportion of study eyes with 10 or more letter loss in BCVA from baseline to 36, 48, 60, and 72 months for Cohort 2
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36, 48, 60, and 72 months
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Visual acuity
Time Frame: 72, 84, 96, and 108 months
|
Proportion of study eyes with 10 or more letter loss in BCVA from baseline to 72, 84, 96, and 108 months for Cohort 1
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72, 84, 96, and 108 months
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Reading speed
Time Frame: 36, 48, 60, and 72 months
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Change from baseline to 36, 48, 60, and 72 months in reading speed as measured by IReST for Cohort 2
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36, 48, 60, and 72 months
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Reading speed
Time Frame: 72, 84, 96, and 108 months
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Change from baseline to 72, 84, 96, and 108 months in reading speed as measured by IReST for Cohort 1
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72, 84, 96, and 108 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Thomas Hohman, PhD, Neurotech Pharmaceuticals, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 12, 2017
Primary Completion (Actual)
May 11, 2021
Study Completion (Actual)
May 11, 2021
Study Registration Dates
First Submitted
March 1, 2017
First Submitted That Met QC Criteria
March 1, 2017
First Posted (Actual)
March 7, 2017
Study Record Updates
Last Update Posted (Actual)
March 17, 2022
Last Update Submitted That Met QC Criteria
March 15, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NTMT-01/02E
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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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