Ciliary Neurotrophic Factor (CNTF) Safety Trial in Patients With Macular Telangiectasia (Mactel)

A Phase 1 Multicenter Open Label Safety and Tolerability Clinical Trial of Ciliary Neurotrophic Factor (CNTF) in Patients With Macular Telangiectasia Type 2 (Mactel)

This study is a phase 1, open label, non-randomized, multi-center, pilot study to evaluate the safety and tolerability of NT-501 implants in 5-7 study participants with Mactel.

Study Overview

• Status: Completed
• Conditions: Idiopathic Juxtafoveal Telangiectasia
• Intervention / Treatment: Biological: NT-501 implant

Detailed Description

Protocol for Extended Follow-up of a Phase 1 Multicenter Open Label Safety and Tolerability Clinical Trial of Ciliary Neurotrophic Factor (CNTF) in Patients with Macular Telangiectasia Type 2 (MacTel)

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Jules Stein Eye Institute
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Retina Associates of Cleveland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The participant must be offered sufficient opportunity to review the informed consent form, agree to the form's contents and sign the protocol's informed consent;
• The participant must have bilateral MacTel;
• Women of childbearing potential and all men must agree to use an effective form of birth control during the study;
• Participant must be medically able to undergo ophthalmic surgery for ECT implant;
• The participant's best-corrected visual acuity 64 letters or better (20/50 or better) in the study eye;

Exclusion Criteria:

• Participant is < 21 years of age;
• Participant is medically unable to comply with study procedures or follow- up visits;
• Participant has evidence of ocular disease other than MacTel that may confound the outcome of the study (e.g., diabetic retinopathy with manifest macular edema, uveitis, etc.);
• Participant has a chronic requirement (e.g., ≥ 4 weeks at a time) for ocular medications and/or has a diagnosed disease, that in the judgment of the examining physician, may be vision threatening or may affect the primary outcome (artificial tears are permitted);
• Participant has evidence of subretinal neovascularization in either eye;
• Participant has evidence of central serous chorio-retinopathy (CSR) in either eye;
• Participant has evidence of pathologic myopia in either eye;
• Participant has had a vitrectomy, penetrating keratoplasty, trabeculectomy or trabeculoplasty;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ciliary Neurotrophic Factor (CNTF)/NT-501; Biological/Vaccine:NT-501 implant	Biological: NT-501 implant; Ciliary neurotrophic factor (CNTF) implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Visual acuity decrease of >=15 letters	3,12, 24 and 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microperimetry	Change of a 10dB at least one point either adjacent to a pre-existing scotoma or in a new area within the central 10 degrees on microperimetric testing	12, 24 and 36 months
OCT	Change in en face area as measured by OCT	12, 24, and 36 months

Collaborators and Investigators

• Sponsor: Neurotech Pharmaceuticals
• Collaborators: The Lowy Medical Research Institute Limited
• Investigators: Study Chair: Weng Tao, Neurotech USA

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: March 30, 2011
• First Submitted That Met QC Criteria: April 1, 2011
• First Posted (Estimate): April 4, 2011

Study Record Updates

• Last Update Posted (Estimate): November 22, 2016
• Last Update Submitted That Met QC Criteria: November 21, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Macular Telangiectasia Type 2; Mactel
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Telangiectasis
• Other Study ID Numbers: NTMT-01