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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 1, 2017
First Posted Date  ICMJE March 7, 2017
Last Update Posted Date November 9, 2018
Actual Study Start Date  ICMJE May 12, 2017
Estimated Primary Completion Date April 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel)
Official Title  ICMJE Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Macular Telangiectasia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Cohort 1
    Participants completed protocol NTMT-01. All participants received surgery to implant NT-501. All participants received ciliary neurotrophic factor (CNTF).
    Interventions:
    • Biological: Ciliary neurotrophic factor (CNTF)
    • Procedure: Surgery
  • 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).
    Interventions:
    • Biological: Ciliary neurotrophic factor (CNTF)
    • Procedure: Surgery
    • Procedure: Surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: March 1, 2017)
73
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 15, 2021
Estimated Primary Completion Date April 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03071965
Other Study ID Numbers  ICMJE NTMT-01/02E
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Neurotech Pharmaceuticals
Study Sponsor  ICMJE Neurotech Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Kenneth J. Mandell, MD, PhD Neurotech Pharmaceuticals, Inc.
PRS Account Neurotech Pharmaceuticals
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP