Title

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

    Phase 1
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    nt-501 ...
  • Study Participants

    7
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)
Study Started
May 31
2011
Primary Completion
Sep 30
2016
Study Completion
Sep 30
2016
Last Update
Nov 22
2016
Estimate

Biological NT-501 implant

Ciliary neurotrophic factor (CNTF) implant

Ciliary Neurotrophic Factor (CNTF)/NT-501 Experimental

Biological/Vaccine:NT-501 implant

Criteria

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;
No Results Posted