Clinical Trial

Phase 4 Study: Long-term Safety and Efficacy of NT-501 in MacTel Type 2, Including Sham Procedure Participants

Recruiting Phase 4
View on ClinicalTrials.gov →
Summary
The purpose of this global, multicenter, open-label, Phase 4 clinical extension study is to evaluate the long-term safety and efficacy of revakinagene taroretcel-lwey (Encelto™; hereinafter referred to as NT-501), in participants with macular telangiectasia type 2 (MacTel) who previously received the intraocular implant in a Phase 1, Phase 2, or Phase 3 clinical study and have retained at least 1 NT-501 at study entry. In addition, this study will evaluate the safety and efficacy of NT501 in participants who previously underwent the sham procedure in a Phase 3 MacTel clinical study and elect to have NT-501 implanted intraocularly in this Phase 4 study.
Protocol Amendment History 2 changes
notable Enrollment reduced: 285 -> 234 participants 2026-08-14
notable Trial sites reduced: 33 -> 26 locations 2026-06-02
Trial Details
NCT Number NCT06971939
Lead Sponsor Neurotech Pharmaceuticals
Conditions Macular Telangiectasia Type 2 (MacTel)
Enrollment 234 participants
Start Date 2025-11-21
Primary Completion 2032-01-15 (estimated)
Study Completion 2032-01-15 (estimated)
Updated on ClinicalTrials.gov 2026-08-13