NCT04729972

Safety Study to Evaluate Bilateral CNTF Implants in Subjects With MacTel Type 2

Phase II, Multicenter, Open-label Safety Study of Bilateral NT-501 in Participants With Macular Telangiectasia Type 2

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Neurotech Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, open-label, 6-month study to evaluate the safety of bilateral CNTF implants in participants with Macular Telangiectasia Type 2.

Detailed description

This was a multicenter, open-label study designed to evaluate the safety of bilateral NT-501 in subjects with MacTel. All subjects who received NT-501 in a single eye prior to or in the Phase 1/2 extension study (NTMT-01/02E) or in 1 of the 2 Phase 3 studies (NTMT-03-A or NTMT-03-B), and met all other eligibility criteria, qualified for participation in the current study; enrolled subjects underwent intraocular implantation of NT-501 in the fellow eye and were followed for 6 months. Note that, throughout this report, all references to "study eye" mean the eye that received NT-501 in the current study (ie, not the eye that was treated in the previous study).

Conditions

• Macular Telangiectasia Type 2

Interventions

Type	Name	Description
COMBINATION_PRODUCT	NT-501 CNTF implant	Single implantation of CNTF-secreting NT-501 device into fellow (untreated) eye

Timeline

• Start date: 2021-07-21
• Primary completion: 2022-12-08
• Completion: 2022-12-08
• First posted: 2021-01-29
• Last updated: 2025-03-26
• Results posted: 2025-03-26

Locations

10 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study
• FDA-regulated device study