NCT03319849

A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2 - Protocol B

A Phase III Multicenter Randomized, Sham Controlled, Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Neurotech Pharmaceuticals · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of the NT-501 implants in participants with macular telangiectasia type 2.

Detailed description

Phase 3, prospective, multicenter, masked, sham-controlled study with the overall study objective to evaluate the efficacy and safety of NT-501 for the treatment of MacTel. Secondary objective was to evaluate the safety of NT-501 in participants with MacTel. This was a multicenter study conducted at 20 study centers in the United States, Australia, Germany, and the United Kingdom.

Conditions

• Macular Telangiectasia Type 2

Interventions

Type	Name	Description
COMBINATION_PRODUCT	NT-501	Each NT-501 implant consisted of hCNTF-secreting NTC-201-6A.02 cells encapsulated within supportive matrices and surrounded by a semipermeable polymer membrane. The NTC-201-6A cells continuously secrete CNTF from the NT-501 implant into the vitreous cavity. Implanted by a qualified Health Care Professional.
PROCEDURE	Sham	The sham surgery involved a superficial conjunctival incision performed under local anesthetic and closure with a single suture.

Timeline

• Start date: 2018-01-22
• Primary completion: 2022-08-31
• Completion: 2022-09-23
• First posted: 2017-10-24
• Last updated: 2024-09-24
• Results posted: 2024-09-24

Locations

27 sites across 3 countries: United States, Australia, Germany

Regulatory

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