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



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - Any
Updated:11/23/2016
Start Date:May 2011
End Date:September 2016

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A Phase 1 Multicenter Open Label Safety and Tolerability Clinical Trial of Ciliary Neurotrophic Factor (CNTF) in Patients With Macular Telangiectasia Type 2 (Mactel)

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.

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)

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;
We found this trial at
2
sites
Cleveland, Ohio 44130
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Cleveland, OH
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100 Stein Plaza
Los Angeles, California 90095
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Los Angeles, CA
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