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

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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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)

Conditions
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Idiopathic Juxtafoveal Telangiectasia

Intervention / Treatment
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* Biological: NT-501 implant


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ciliary Neurotrophic Factor (CNTF)/NT-501<br>Biological/Vaccine:NT-501 implant | Biological: NT-501 implant<br>* Ciliary neurotrophic factor (CNTF) implant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Visual acuity decrease of >=15 letters | 3,12, 24 and 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microperimetry | Change of a 10dB at least one point either adjacent to a pre-existing scotoma or in a new area within the central 10 degrees on microperimetric testing | 12, 24 and 36 months | 
| OCT | Change in en face area as measured by OCT | 12, 24, and 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mactel, Macular Telangiectasia Type 2