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

Primary Purpose

Macular Telangiectasia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ciliary neurotrophic factor (CNTF)
Surgery
Surgery
Sponsored by
Neurotech Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Telangiectasia

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stein Eye Institute / David Geffen School of Medicine
  • University of Miami-Miller School of Medicine, Bascom Palmer Eye Institute
  • Emory University School of Medicine, Dept of Ophthalmology, Emory University Eye Center
  • NIH Clinical Center
  • Massachusetts Eye and Ear Infirmary
  • University of Michigan, Kellogg Eye Center
  • Retina Associates of Cleveland, Inc
  • University of Wisconsin-Madison, Department of Ophthalmology and Visual Sciences
  • Sydney Eye Hospital
  • Centre for Eye Research Australia
  • Lions Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Arm Description

Participants completed protocol NTMT-01. All participants received surgery to implant NT-501. All participants received ciliary neurotrophic factor (CNTF).

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).

Outcomes

Primary Outcome Measures

Ellipsoid zone (area of IS/OS loss)
Change from baseline to 36, 48, 60, 72 months as measured by SD-OCT for Cohort 2
Ellipsoid zone (area of IS/OS loss)
Change from baseline to 72, 84, 96, and 108 months as measured by SD-OCT for Cohort 1

Secondary Outcome Measures

Retinal sensitivity (dB)
Change from baseline to 36, 48, 60, and 72 months as measured by microperimetry for Cohort 2
Retinal sensitivity (dB)
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)
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)
Proportion of study eyes with a 35% or more increase from baseline at 72, 84, 96, and 108 months for Cohort 1
Visual acuity
Change in best corrected visual acuity from baseline to 36, 48, 60, and 72 months for Cohort 2
Visual acuity
Change in best corrected visual acuity from baseline to 72, 84, 96, and 108 months for Cohort 1
Visual acuity
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
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
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
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
Change from baseline to 36, 48, 60, and 72 months in reading speed as measured by IReST for Cohort 2
Reading speed
Change from baseline to 72, 84, 96, and 108 months in reading speed as measured by IReST for Cohort 1

Full Information

First Posted
March 1, 2017
Last Updated
March 15, 2022
Sponsor
Neurotech Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03071965
Brief Title
Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel)
Official Title
Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 12, 2017 (Actual)
Primary Completion Date
May 11, 2021 (Actual)
Study Completion Date
May 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurotech Pharmaceuticals

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Telangiectasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Participants completed protocol NTMT-01. All participants received surgery to implant NT-501. All participants received ciliary neurotrophic factor (CNTF).
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
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).
Intervention Type
Biological
Intervention Name(s)
Ciliary neurotrophic factor (CNTF)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Surgery to implant device for NT-501
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Sham surgery
Primary Outcome Measure Information:
Title
Ellipsoid zone (area of IS/OS loss)
Description
Change from baseline to 36, 48, 60, 72 months as measured by SD-OCT for Cohort 2
Time Frame
36, 48, 60, and 72 months
Title
Ellipsoid zone (area of IS/OS loss)
Description
Change from baseline to 72, 84, 96, and 108 months as measured by SD-OCT for Cohort 1
Time Frame
72, 84, 96, and 108 months
Secondary Outcome Measure Information:
Title
Retinal sensitivity (dB)
Description
Change from baseline to 36, 48, 60, and 72 months as measured by microperimetry for Cohort 2
Time Frame
36, 48, 60, and 72 months
Title
Retinal sensitivity (dB)
Description
Change from baseline to 72, 84, 96, and 108 months as measured by microperimetry for Cohort 1
Time Frame
72, 84, 96, and 108 months
Title
Increase in ellipsoid zone (area of IS/OS loss)
Description
Proportion of study eyes with a 35% or more increase from baseline at 36, 48, 60, and 72 months for Cohort 2
Time Frame
36, 48, 60, and 72 months
Title
Increase in ellipsoid zone (area of IS/OS loss)
Description
Proportion of study eyes with a 35% or more increase from baseline at 72, 84, 96, and 108 months for Cohort 1
Time Frame
72, 84, 96, and 108 months
Title
Visual acuity
Description
Change in best corrected visual acuity from baseline to 36, 48, 60, and 72 months for Cohort 2
Time Frame
36, 48, 60, and 72 months
Title
Visual acuity
Description
Change in best corrected visual acuity from baseline to 72, 84, 96, and 108 months for Cohort 1
Time Frame
72, 84, 96, and 108 months
Title
Visual acuity
Description
Proportion of study eyes with 15 or more letter loss in BCVA from baseline to 36, 48, 60, and 72 months for Cohort 2
Time Frame
36, 48, 60, and 72 months
Title
Visual acuity
Description
Proportion of study eyes with 15 or more letter loss in BCVA from baseline to 72, 84, 96, and 108 months for Cohort 1
Time Frame
72, 84, 96, and 108 months
Title
Visual acuity
Description
Proportion of study eyes with 10 or more letter loss in BCVA from baseline to 36, 48, 60, and 72 months for Cohort 2
Time Frame
36, 48, 60, and 72 months
Title
Visual acuity
Description
Proportion of study eyes with 10 or more letter loss in BCVA from baseline to 72, 84, 96, and 108 months for Cohort 1
Time Frame
72, 84, 96, and 108 months
Title
Reading speed
Description
Change from baseline to 36, 48, 60, and 72 months in reading speed as measured by IReST for Cohort 2
Time Frame
36, 48, 60, and 72 months
Title
Reading speed
Description
Change from baseline to 72, 84, 96, and 108 months in reading speed as measured by IReST for Cohort 1
Time Frame
72, 84, 96, and 108 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Hohman, PhD
Organizational Affiliation
Neurotech Pharmaceuticals, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Stein Eye Institute / David Geffen School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of Miami-Miller School of Medicine, Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory University School of Medicine, Dept of Ophthalmology, Emory University Eye Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
NIH Clinical Center
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan, Kellogg Eye Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Retina Associates of Cleveland, Inc
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
University of Wisconsin-Madison, Department of Ophthalmology and Visual Sciences
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Sydney Eye Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Centre for Eye Research Australia
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Lions Eye Institute
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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

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