Overview

This trial is active, not recruiting.

Condition macular telangiectasia type 2
Treatments ciliary neurotrophic factor (cntf), surgery
Phase phase 2
Sponsor Neurotech Pharmaceuticals
Collaborator Lowy Medical Research Institute (LMRI)
Start date April 2014
End date April 2017
Trial size 68 participants
Trial identifier NCT01949324, NTMT-02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
The investigational product is the NT-501 encapsulated cell system which consists of cells encapsulated within a semi-permeable polymer membrane and supportive matrices. NT-501 contains NTC-201 cells that were derived from the NTC-200 cell line by genetic modification so as to secrete recombinant human ciliary neurotrophic factor (CNTF).
ciliary neurotrophic factor (cntf)
surgery
Surgery to implant device for NT-501 arm and sham surgery for Sham arm
(Sham Comparator)
Non-penetrating sham procedure to mimic implant procedure
surgery
Surgery to implant device for NT-501 arm and sham surgery for Sham arm

Primary Outcomes

Measure
Ellipsoid zone (area of IS/OS loss) as measured by en face imagining by SDOCT in study eye(s)
time frame: 24 months

Secondary Outcomes

Measure
Ellipsoid zone
time frame: 12 months
Retinal sensitivity (dB) as measured by microperimetry
time frame: 12 and 24 months
Increase in ellipsoid zone
time frame: 12 and 24 months
Visual Acuity
time frame: 12 and 24 months
Visual Acuity
time frame: 12 and 24 Months
Visual Acuity
time frame: 12 and 24 Months
Reading Speed
time frame: 12 and 24 Months

Eligibility Criteria

Male or female participants from 21 years up to 80 years old.

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

Additional Information

Official title A Phase 2 Multicenter Randomized Clinical Trial of Ciliary Neurotrophic Factor (CNTF) for Macular Telangiectasia Type 2 (MacTel)
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Neurotech Pharmaceuticals.