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

NCT06971939 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2026-04-29

No results posted yet for this study

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. 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.

Conditions

  • Macular Telangiectasia Type 2 (MacTel)

Interventions

COMBINATION_PRODUCT

NT-501/revakinagene taroretcel-lwey

NT-501 is surgically implanted into the vitreous cavity to continuously release recombinant human ciliary neurotrophic factor (CNTF).

Sponsors & Collaborators

  • Neurotech Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Thomas Aaberg, Jr, MD · Neurotech Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-21
Primary Completion
2032-01-15
Completion
2032-01-15
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Australia
  • France
  • Germany
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06971939 on ClinicalTrials.gov