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Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel)
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
Details
| Lead sponsor | Neurotech Pharmaceuticals |
|---|---|
| Phase | PHASE2 |
| Status | COMPLETED |
| Enrolment | 70 |
| Start date | Fri May 12 2017 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue May 11 2021 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- MacTel (Macular Telangiectasia) Type 2
Interventions
- Ciliary neurotrophic factor (CNTF)
- Surgery
- Surgery
Countries
United States, Australia