Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel)
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Ellipsoid zone (area of IS/OS loss) [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) [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
- Retinal sensitivity (dB) [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) [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) [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) [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 [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 [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 [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 [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 [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 [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 [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 [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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stein Eye Institute / David Geffen School of Medicine | Los Angeles | California | United States | 90095 |
| 2 | University of Miami-Miller School of Medicine, Bascom Palmer Eye Institute | Miami | Florida | United States | 33136 |
| 3 | Emory University School of Medicine, Dept of Ophthalmology, Emory University Eye Center | Atlanta | Georgia | United States | 30322 |
| 4 | NIH Clinical Center | Rockville | Maryland | United States | 20892 |
| 5 | Massachusetts Eye and Ear Infirmary | Boston | Massachusetts | United States | 02114 |
| 6 | University of Michigan, Kellogg Eye Center | Ann Arbor | Michigan | United States | 48105 |
| 7 | Retina Associates of Cleveland, Inc | Cleveland | Ohio | United States | 44122 |
| 8 | University of Wisconsin-Madison, Department of Ophthalmology and Visual Sciences | Madison | Wisconsin | United States | 53705 |
| 9 | Sydney Eye Hospital | Sydney | New South Wales | Australia | 2000 |
| 10 | Centre for Eye Research Australia | East Melbourne | Victoria | Australia | 3002 |
| 11 | Lions Eye Institute | Nedlands | Western Australia | Australia | 6009 |
Sponsors and Collaborators
- Neurotech Pharmaceuticals
Investigators
- Study Chair: Thomas Hohman, PhD, Neurotech Pharmaceuticals, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NTMT-01/02E