Ciliary Neurotrophic Factor (CNTF) Safety Trial in Patients With Macular Telangiectasia (Mactel)
This trial has been completed.
|Condition||idiopathic juxtafoveal telangiectasia|
|Collaborator||The Lowy Medical Research Institute Limited|
|Start date||May 2011|
|End date||September 2016|
|Trial size||7 participants|
|Trial identifier||NCT01327911, NTMT-01|
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.
|Endpoint classification||safety study|
|Intervention model||single group assignment|
time frame: 3,12, 24 and 36 months
time frame: 12, 24 and 36 months
time frame: 12, 24, and 36 months
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;
|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)|
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