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

Phase 1

Completed

• Conditions: Idiopathic Juxtafoveal Telangiectasia
• Interventions: Biological: NT-501 implant

• Registration Number: NCT01327911
• Lead Sponsor: Neurotech Pharmaceuticals

Brief Summary

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.

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 Timeline

• Study First Submitted: 2011-03-30
• Study First Submitted QC: 2011-04-01
• Study First Posted: 2011-04-04
• Study Start: 2011-05
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-21
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ciliary Neurotrophic Factor (CNTF)/NT-501	NT-501 implant	Biological/Vaccine:NT-501 implant

Primary Outcome Measures

Name	Time	Method
Visual Acuity	3,12, 24 and 36 months	Visual acuity decrease of \>=15 letters

Secondary Outcome Measures

Name	Time	Method
Microperimetry	12, 24 and 36 months	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
OCT	12, 24, and 36 months	Change in en face area as measured by OCT

Trial Locations

Locations (2)

Retina Associates of Cleveland; 🇺🇸 Cleveland, Ohio, United States

Jules Stein Eye Institute; 🇺🇸 Los Angeles, California, United States