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

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Trial Profile

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 of Trial: Phase III

Latest Information Update: 21 Mar 2025

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At a glance

  • Drugs Revakinagene taroretcel (Primary)
  • Indications Retinal telangiectasis
  • Focus Registrational; Therapeutic Use
  • Acronyms NTMT-03-B
  • Sponsors GNT Pharma; Neurotech USA

Most Recent Events

  • 06 Mar 2025 According to a Neurotech SA media release, based on results from two phase 3 trials NCT03316300 and NCT03319849, the U.S. Food and Drug Administration (FDA), has approved ENCELTO (revakinagene taroretcel-lwey) for the treatment of Macular Telangiectasia type 2 (MacTel).
  • 20 Jun 2024 According to a Neurotech SA media release, company announced that the U.S. Food and Drug Administration (FDA), has determined that the Biologic License Application (BLA) for NT-501 for the treatment of MacTel is sufficiently complete to permit a substantive review. The application has a prescription drug user fee act (PDUFA) goal date of December 17, 2024.
  • 03 Feb 2023 Status changed from active, no longer recruiting to completed.

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