We initiated this project at the NEI in fiscal year 2014 as a site in the phase 2 clinical trial (14-EI-0078) testing CNTF for macular telangiectasia (MacTel). We met the accrual goal at the NEI site and study analysis has been completed, with publication of the primary results. The trial met its primary endpoint, with eyes receiving sham treatment showing 31% greater progression of neurodegeneration than the CNTF-treated eyes using an en face OCT measure of change in area of outer retinal disruption, with difference in mean area of photoreceptor loss of 0.05 0.03 mm2 (p = 0.04) at 24 months. The phase 2 protocol has been terminated following completion. Participants in the phase 2 trial were enrolled in an extension study (17-EI-0136) to study effects of the CNTF implant at years 3, 4, 5, and 6, and follow up continues for site participants in this protocol. In 2018, we were activated as a site in the phase 3 clinical trial (18-EI-0055) testing CNTF (NT-501, Renexus) for Mactel (listed as a separate project).

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Investigator-Initiated Intramural Research Projects (ZIA)
Project #
1ZIAEY000536-06
Application #
10020023
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
6
Fiscal Year
2019
Total Cost
Indirect Cost
Name
U.S. National Eye Institute
Department
Type
DUNS #
City
State
Country
Zip Code