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A Phase 2 Multicenter Randomized Clinical Trial of CNTF for MacTel

NCT01949324 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2018-09-12

No results posted yet for this study

Summary

This study is a phase 2, randomized, multi-center, single-masked study to evaluate the efficacy and safety of the NT-501 implants in participants with Mactel.

Conditions

  • Macular Telangiectasia Type 2

Interventions

BIOLOGICAL

Ciliary neurotrophic factor (CNTF)

Ciliary neurotrophic factor released from NT-501 encapsulated cell implant

PROCEDURE

Sham procedure

Sham surgery for Sham arm

DEVICE

NT-501 Implant

NT-501 encapsulated cell implant

PROCEDURE

NT-501 Implant procedure

Surgery to implant device for NT-501 encapsulated cell implant releasing human ciliary neurotrophic factor arm

Sponsors & Collaborators

  • The Lowy Medical Research Institute Limited

    collaborator OTHER

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • Neurotech Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2017-04-14
Completion
2017-05-22
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Australia

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 NCT01949324 on ClinicalTrials.gov