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Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel)

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ClinicalTrials.gov Identifier: NCT03071965
Recruitment Status : Enrolling by invitation
First Posted : March 7, 2017
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
Neurotech Pharmaceuticals

Brief Summary:
This study is a prospective, phase 2 extension study of participants previously enrolled in NTMT-01 and of participants enrolled in 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.

Condition or disease Intervention/treatment Phase
Macular Telangiectasia Biological: Ciliary neurotrophic factor (CNTF) Procedure: Surgery Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 73 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel)
Actual Study Start Date : May 12, 2017
Estimated Primary Completion Date : April 15, 2021
Estimated Study Completion Date : April 15, 2021

Resource links provided by the National Library of Medicine


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).
Biological: 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.

Procedure: Surgery
Surgery to implant device for NT-501

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).
Biological: 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.

Procedure: Surgery
Surgery to implant device for NT-501

Procedure: Surgery
Sham surgery




Primary Outcome Measures :
  1. Ellipsoid zone (area of IS/OS loss) [ Time Frame: 36, 48, 60, and 72 months ]
    Change from baseline to 36, 48, 60, 72 months as measured by SD-OCT for Cohort 2

  2. Ellipsoid zone (area of IS/OS loss) [ Time Frame: 72, 84, 96, and 108 months ]
    Change from baseline to 72, 84, 96, and 108 months as measured by SD-OCT for Cohort 1


Secondary Outcome Measures :
  1. Retinal sensitivity (dB) [ Time Frame: 36, 48, 60, and 72 months ]
    Change from baseline to 36, 48, 60, and 72 months as measured by microperimetry for Cohort 2

  2. Retinal sensitivity (dB) [ Time Frame: 72, 84, 96, and 108 months ]
    Change from baseline to 72, 84, 96, and 108 months as measured by microperimetry for Cohort 1

  3. Increase in ellipsoid zone (area of IS/OS loss) [ Time Frame: 36, 48, 60, and 72 months ]
    Proportion of study eyes with a 35% or more increase from baseline at 36, 48, 60, and 72 months for Cohort 2

  4. Increase in ellipsoid zone (area of IS/OS loss) [ Time Frame: 72, 84, 96, and 108 months ]
    Proportion of study eyes with a 35% or more increase from baseline at 72, 84, 96, and 108 months for Cohort 1

  5. Visual acuity [ Time Frame: 36, 48, 60, and 72 months ]
    Change in best corrected visual acuity from baseline to 36, 48, 60, and 72 months for Cohort 2

  6. Visual acuity [ Time Frame: 72, 84, 96, and 108 months ]
    Change in best corrected visual acuity from baseline to 72, 84, 96, and 108 months for Cohort 1

  7. Visual acuity [ Time Frame: 36, 48, 60, and 72 months ]
    Proportion of study eyes with 15 or more letter loss in BCVA from baseline to 36, 48, 60, and 72 months for Cohort 2

  8. 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

  9. Visual acuity [ Time Frame: 36, 48, 60, and 72 months ]
    Proportion of study eyes with 10 or more letter loss in BCVA from baseline to 36, 48, 60, and 72 months for Cohort 2

  10. 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

  11. Reading speed [ Time Frame: 36, 48, 60, and 72 months ]
    Change from baseline to 36, 48, 60, and 72 months in reading speed as measured by IReST for Cohort 2

  12. Reading speed [ Time Frame: 72, 84, 96, and 108 months ]
    Change from baseline to 72, 84, 96, and 108 months in reading speed as measured by IReST for Cohort 1



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071965


Locations
United States, California
Stein Eye Institute / David Geffen School of Medicine
Los Angeles, California, United States, 90095
United States, Florida
University of Miami-Miller School of Medicine, Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
United States, Georgia
Emory University School of Medicine, Dept of Ophthalmology, Emory University Eye Center
Atlanta, Georgia, United States, 30322
United States, Maryland
NIH Clinical Center
Rockville, Maryland, United States, 20892
United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan, Kellogg Eye Center
Ann Arbor, Michigan, United States, 48105
United States, Ohio
Retina Associates of Cleveland, Inc
Cleveland, Ohio, United States, 44122
United States, Wisconsin
University of Wisconsin-Madison, Department of Ophthalmology and Visual Sciences
Madison, Wisconsin, United States, 53705
Australia, New South Wales
Sydney Eye Hospital
Sydney, New South Wales, Australia, 2000
Australia, Victoria
Centre for Eye Research Australia
East Melbourne, Victoria, Australia, 3002
Australia, Western Australia
Lions Eye Institute
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Neurotech Pharmaceuticals
Investigators
Study Chair: Kenneth J. Mandell, MD, PhD Neurotech Pharmaceuticals, Inc.

Responsible Party: Neurotech Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03071965     History of Changes
Other Study ID Numbers: NTMT-01/02E
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Telangiectasis
Vascular Diseases
Cardiovascular Diseases