Ciliary Neurotrophic Factor (CNTF) Safety Trial in Patients With Macular Telangiectasia (Mactel) (NCT01327911) | Clinical Trial Compass
CompletedPhase 1
Ciliary Neurotrophic Factor (CNTF) Safety Trial in Patients With Macular Telangiectasia (Mactel)
United States7 participantsStarted 2011-05
Plain-language 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.
Who can participate
Age range21 Years
SexALL
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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;