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

Neurotech

Status and phase

Completed

Phase 1

Conditions

Idiopathic Juxtafoveal Telangiectasia

Treatments

Biological: NT-501 implant

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01327911

NTMT-01

Details and patient eligibility

About

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.

Full 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)

Enrollment

7 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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;