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 |
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.
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)
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
Click here to add this to my saved trials
Click here to add this to my saved trials