Clinical Trials Logo

Clinical Trial Summary

This study is to determine the long-term levels of CNTF, and the clinical safety and efficacy of the NT-501 implants with the Medica Hollow Fiber Membrane (MHFM) in participants with macular telangiectasia type 2.


Clinical Trial Description

Two parallel randomized, controlled Phase 3 clinical trials showed that placing an NT-501 in the eyes of subjects with macular telangiectasia type 2 (MacTel) provides vision benefit with an acceptable risk profile. The NT-501 device used in these Phase 3 trials has a hollow fiber membrane (HFM) which houses the CNTF producing engineered NTC-201-6A cells. The produced CNTF passes through the membrane into the vitreous cavity of the affected eye and similarly required cell nutrients pass from the vitreous cavity through the membrane to the NTC-201-6A cells. NT-501 used in the above mentioned Phase 3 studies was manufactured with the clinical HFM (referred to as CHFM) from a single sourced supplier. Another supplier of this critical HFM component of the NT-501 has been identified. This membrane will be referred to as the Medica Hollow Fiber Membrane (MHFM). Though the NT-501 product manufactured with the MHFM has the same configuration, same RPE cells, and produces CNTF levels similar to the original NT-501 product manufactured with clinical membrane (CHFM) when tested in vivo (animal model), it has not been tested in humans. The purpose of this study is to characterize the clinical safety and efficacy of NT-501 with MHFM, consistent with the clinical safety and efficacy of NT-501 with CHFM. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06397131
Study type Interventional
Source Neurotech Pharmaceuticals
Contact Ellie Zapata
Phone 401-495-2498
Email e.zapata@neurotechusa.com
Status Not yet recruiting
Phase Phase 3
Start date April 1, 2025
Completion date July 24, 2026

See also
  Status Clinical Trial Phase
Completed NCT03316300 - A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2 - Protocol A Phase 3
Completed NCT03319849 - A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2 Phase 3
Completed NCT04729972 - Safety Study to Evaluate Bilateral CNTF Implants in Subjects With MacTel Type 2 Phase 2
Active, not recruiting NCT04907084 - Serine and Fenofibrate Study in Patients With MacTel Type 2 Phase 2
Completed NCT01949324 - A Phase 2 Multicenter Randomized Clinical Trial of CNTF for MacTel Phase 2