A Phase 2 Multicenter Randomized Clinical Trial of CNTF for MacTel

Status:	Completed
Conditions:	Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	21 - 80
Updated:	9/14/2018
Start Date:	April 2014
End Date:	May 22, 2017

A Phase 2 Multicenter Randomized Clinical Trial of Ciliary Neurotrophic Factor (CNTF) for Macular Telangiectasia Type 2 (MacTel)

This study is a phase 2, randomized, multi-center, single-masked study to evaluate the
efficacy and safety of the NT-501 implants in participants with Mactel.

Inclusion Criteria:

- Participant must be offered sufficient opportunity to review and to understand the
informed consent form, agree to the form's contents and sign the protocol's informed
consent

- Participant must have at least one study eye with a positive diagnosis of MacTel Type
2

- Participant must have an IS/OS PR break in the study eye(s) and en face ellipsoid zone
(area of IS/OS loss) as measured by SDOCT between 0.16 mm2 and 4.00 mm2

- If female, participant must be incapable of pregnancy

- If male, participant must agree to use an effective form of birth control during the
study

Exclusion Criteria:

- Participant is unable to provide informed consent

- Participant is less than 21 years of age or greater than 80 years of age

- Participant is medically unable to comply with study procedures or follow-up visits

- Participant was a study subject in any other clinical trial of an intervention (drug
or device) within the last 6 months

- Participant is pregnant or breastfeeding

We found this trial at

sites

Bascom Palmer

Miami, Florida 33136

1319

from

Miami, FL