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

Phase 2CompletedNCT03071965

Neurotech Pharmaceuticals70 enrolled

Overview

This was a prospective, multicenter, single-masked, sham-controlled extension study designed to provide long-term safety and efficacy follow-up data for subjects with MacTel who had NT-501 implanted intraocularly and/or underwent sham surgery in the respective precursor study (NTMT-01 or NTMT-02). A substudy was conducted in which subjects enrolled in study (NTMT-02), who had 1 study-eligible eye that underwent sham surgery, were offered the option to have NT-501 implanted in the same study eye. Of the 19 subjects who had 1 study-eligible eye and underwent sham surgery in the Cohort 2 precursor study (NTMT-02), 16 subjects elected to have NT-501 implanted in the same study eye during the substudy

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

MacTel (Macular Telangiectasia) Type 2

Interventions

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (11)

Stein Eye Institute / David Geffen School of Medicine

Los Angeles, California, United States

University of Miami-Miller School of Medicine, Bascom Palmer Eye Institute

Miami, Florida, United States

Emory University School of Medicine, Dept of Ophthalmology, Emory University Eye Center

Atlanta, Georgia, United States

NIH Clinical Center

Rockville, Maryland, United States

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States

University of Michigan, Kellogg Eye Center

Ann Arbor, Michigan, United States

Retina Associates of Cleveland, Inc

Cleveland, Ohio, United States

University of Wisconsin-Madison, Department of Ophthalmology and Visual Sciences

Madison, Wisconsin, United States

Sydney Eye Hospital

Sydney, New South Wales, Australia

Centre for Eye Research Australia

East Melbourne, Victoria, Australia

...and 1 more locations

Outcomes

Primary Outcomes

Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1

Change from baseline to 72, 84, 96 and 108 months post-surgery (based on participants' original implant date during precursor study) by SD-OCT for Cohort 1

Time frame: 72, 84, 96, and 108 months (based on participants' original implant date during precursor study)

Ellipsoid Zone (Area of IS/OS Loss) - Cohort 2

Change in EZ from baseline to 36, 48, 60 and 72 Months post-surgery (based on participants' original implant date during precursor study). Cohort 2 sham surgery arm includes 16 participants (16 eyes) that received an NT-501 following their Month 36 follow-up

Time frame: Baseline to 36, 48, 60 and 72 Months post-surgery (based on participants' original implant date during precursor study)

Secondary Outcomes

Change in Retinal Sensitivity (dB) From Baseline - Cohort 2 Only

Baseline to 72 Months - analyses also presented for additional times: 36, 48, and 60 Months post-surgery (based on participants' original implant date during precursor study) . Cohort 2 sham surgery arm includes 16 participants (16 eyes) that received an NT-501 following their Month 36 follow-up in this study.

Time frame: Baseline to 72 Months (based on participants' original implant date)

Change in BCVA From Baseline for Cohort 1

Baseline to 108 Months - analyses also presented for additional times: 84, 96 and 108 Months (based on participants' original implant date)

Time frame: Baseline to 108 Months (based on participants' original implant date)

Change in BCVA From Baseline for Cohort 2

Baseline to 72 Months - analyses also presented for additional times: 36, 48, and 60 Months (based on participants' original implant date during precursor study) . Cohort 2 sham surgery arm includes 16 participants (16 eyes) that received an NT-501 following their Month 36 follow-up

Time frame: Baseline to 72 Months (based on participants' original implant date)

Change in Reading Speed From Baseline - Cohort 2 Only

Time frame: Baseline to 72 Months (based on participants' original implant date)