NCT03071965

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Neurotech Pharmaceuticals · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• MacTel (Macular Telangiectasia) Type 2

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-05-12
• Primary completion: 2021-05-11
• Completion: 2021-05-11
• First posted: 2017-03-07
• Last updated: 2025-05-09
• Results posted: 2025-05-09

Locations

11 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study