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

Macular Telangiectasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03071965
• Other study ID #: NTMT-01/02E
• Status: Completed
• Phase: Phase 2
• Start date: May 12, 2017
• Est. completion date: May 11, 2021

Study information

• Verified date: March 2022
• Source: Neurotech Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 11, 2021
• Est. primary completion date: May 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Macular Telangiectasia
• Telangiectasis

Intervention

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
• Surgery
Sham surgery

Locations

Country	Name	City	State
Australia	Centre for Eye Research Australia	East Melbourne	Victoria
Australia	Lions Eye Institute	Nedlands	Western Australia
Australia	Sydney Eye Hospital	Sydney	New South Wales
United States	University of Michigan, Kellogg Eye Center	Ann Arbor	Michigan
United States	Emory University School of Medicine, Dept of Ophthalmology, Emory University Eye Center	Atlanta	Georgia
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts
United States	Retina Associates of Cleveland, Inc	Cleveland	Ohio
United States	Stein Eye Institute / David Geffen School of Medicine	Los Angeles	California
United States	University of Wisconsin-Madison, Department of Ophthalmology and Visual Sciences	Madison	Wisconsin
United States	University of Miami-Miller School of Medicine, Bascom Palmer Eye Institute	Miami	Florida
United States	NIH Clinical Center	Rockville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Neurotech Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ellipsoid zone (area of IS/OS loss)	Change from baseline to 36, 48, 60, 72 months as measured by SD-OCT for Cohort 2	36, 48, 60, and 72 months
Primary	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	72, 84, 96, and 108 months
Secondary	Retinal sensitivity (dB)	Change from baseline to 36, 48, 60, and 72 months as measured by microperimetry for Cohort 2	36, 48, 60, and 72 months
Secondary	Retinal sensitivity (dB)	Change from baseline to 72, 84, 96, and 108 months as measured by microperimetry for Cohort 1	72, 84, 96, and 108 months
Secondary	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	36, 48, 60, and 72 months
Secondary	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	72, 84, 96, and 108 months
Secondary	Visual acuity	Change in best corrected visual acuity from baseline to 36, 48, 60, and 72 months for Cohort 2	36, 48, 60, and 72 months
Secondary	Visual acuity	Change in best corrected visual acuity from baseline to 72, 84, 96, and 108 months for Cohort 1	72, 84, 96, and 108 months
Secondary	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	36, 48, 60, and 72 months
Secondary	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	72, 84, 96, and 108 months
Secondary	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	36, 48, 60, and 72 months
Secondary	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	72, 84, 96, and 108 months
Secondary	Reading speed	Change from baseline to 36, 48, 60, and 72 months in reading speed as measured by IReST for Cohort 2	36, 48, 60, and 72 months
Secondary	Reading speed	Change from baseline to 72, 84, 96, and 108 months in reading speed as measured by IReST for Cohort 1	72, 84, 96, and 108 months