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

Completed · Phase 2 · Has a placebo group

Conditions studied: MacTel (Macular Telangiectasia) Type 2

In brief

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

Key facts

Study ID

NCT03071965

Run by

Neurotech Pharmaceuticals

People needed

70

Starts

2017-05-12

Expected to finish

2021-05-11

Last updated by the study team

2025-05-09

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• There are no Exclusion Criteria

Where it is running

• 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
• Lions Eye Institute — Nedlands, Western Australia, Australia

Full record on ClinicalTrials.gov

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