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

NCT03316300 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-09-24

Study results available
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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.

Conditions

  • Macular Telangiectasia Type 2 (MacTel)

Interventions

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 Procedure

The sham surgery involved a superficial conjunctival incision performed under local anesthetic and closure with a single suture.

Sponsors & Collaborators

  • The Lowy Medical Research Institute Limited

    collaborator OTHER

  • Neurotech Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Paul S Bernstein, MD · University of Utah - John A. Moran Eye Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-24
Primary Completion
2022-08-31
Completion
2022-09-23
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Australia
  • France
  • 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 NCT03316300 on ClinicalTrials.gov