A Phase 2 Multicenter Randomized Clinical Trial of Ciliary Neurotrophic Factor (CNTF) for Macular Telangiectasia Type 2 (MacTel)

Neurotech Pharmaceuticals11 sites in 2 countries67 target enrollmentApril 2014

ConditionsMacular Telangiectasia Type 2

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Macular Telangiectasia Type 2
Sponsor: Neurotech Pharmaceuticals
Enrollment: 67
Locations: 11
Primary Endpoint: Ellipsoid zone (area of IS/OS loss) as measured by en face imagining by SDOCT in study eye(s)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 2014

End Date

May 22, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Neurotech Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participant must be offered sufficient opportunity to review and to understand the informed consent form, agree to the form's contents and sign the protocol's informed consent
•Participant must have at least one study eye with a positive diagnosis of MacTel Type 2
•Participant must have an IS/OS PR break in the study eye(s) and en face ellipsoid zone (area of IS/OS loss) as measured by SDOCT between 0.16 mm2 and 4.00 mm2
•If female, participant must be incapable of pregnancy
•If male, participant must agree to use an effective form of birth control during the study

Exclusion Criteria

•Participant is unable to provide informed consent
•Participant is less than 21 years of age or greater than 80 years of age
•Participant is medically unable to comply with study procedures or follow-up visits
•Participant was a study subject in any other clinical trial of an intervention (drug or device) within the last 6 months
•Participant is pregnant or breastfeeding