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

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

Sponsors

Lead Sponsor: Neurotech Pharmaceuticals

Source 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.

Overall Status Enrolling by invitation
Start Date May 12, 2017
Completion Date April 15, 2021
Primary Completion Date April 15, 2021
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Ellipsoid zone (area of IS/OS loss) 36, 48, 60, and 72 months
Ellipsoid zone (area of IS/OS loss) 72, 84, 96, and 108 months
Secondary Outcome
Measure Time Frame
Retinal sensitivity (dB) 36, 48, 60, and 72 months
Retinal sensitivity (dB) 72, 84, 96, and 108 months
Increase in ellipsoid zone (area of IS/OS loss) 36, 48, 60, and 72 months
Increase in ellipsoid zone (area of IS/OS loss) 72, 84, 96, and 108 months
Visual acuity 36, 48, 60, and 72 months
Visual acuity 72, 84, 96, and 108 months
Visual acuity 36, 48, 60, and 72 months
Visual acuity 72, 84, 96, and 108 months
Visual acuity 36, 48, 60, and 72 months
Visual acuity 72, 84, 96, and 108 months
Reading speed 36, 48, 60, and 72 months
Reading speed 72, 84, 96, and 108 months
Enrollment 73
Condition
Intervention

Intervention Type: Biological

Intervention Name: Ciliary neurotrophic factor (CNTF)

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: Surgery

Description: Surgery to implant device for NT-501

Intervention Type: Procedure

Intervention Name: Surgery

Description: Sham surgery

Arm Group Label: Cohort 2

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

Gender: All

Minimum Age: 21 Years

Maximum Age: 80 Years

Healthy Volunteers: No

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

Australia

United States

Verification Date

November 2018

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Cohort 1

Type: Experimental

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

Label: Cohort 2

Type: Experimental

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).

Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov