Overview

This trial has been completed.

Condition idiopathic juxtafoveal telangiectasia
Treatment nt-501 implant
Phase phase 1
Sponsor Neurotech Pharmaceuticals
Collaborator The Lowy Medical Research Institute Limited
Start date May 2011
End date September 2016
Trial size 7 participants
Trial identifier NCT01327911, NTMT-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Biological/Vaccine:NT-501 implant
nt-501 implant
Ciliary neurotrophic factor (CNTF) implant

Primary Outcomes

Measure
Visual Acuity
time frame: 3,12, 24 and 36 months

Secondary Outcomes

Measure
Microperimetry
time frame: 12, 24 and 36 months
OCT
time frame: 12, 24, and 36 months

Eligibility Criteria

Male or female participants at least 21 years old.

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;

Additional Information

Official title A Phase 1 Multicenter Open Label Safety and Tolerability Clinical Trial of Ciliary Neurotrophic Factor (CNTF) in Patients With Macular Telangiectasia Type 2 (Mactel)
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)
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Neurotech Pharmaceuticals.