Phase 3 Renexus (NT-501) Trial

CNTF-Secreting Cells for Treatment of MacTel

In a collaboration with Neurotech Pharmaceuticals, the Lowy Medical Research Institute is testing the safety and efficacy of ciliary neurotrophic factor (CNTF) in patients with macular telangiectasia type 2 in a Phase 3 clinical trial.  This is a multi-center trial, with clinical sites in the United States, Europe, and Australia.

Ciliary neurotrophic factor is a therapeutic macromolecule that has been tested in numerous preclinical applications for its ability to decrease photoreceptor degeneration in disease models of the eye. Among the many growth factors, cytokines, and neurotrophic factors that have been tested for their ability to minimize photoreceptor loss, CNTF is among the most effective. However, CNTF degrades relatively quickly when injected into the eye. Therefore, it requires a special delivery device.

Neurotech developed an encapsulated cell technology implant (NT-501) to address this problem. The device is surgically implanted into the vitreous, which is the clear jelly-like substance that fills the area between the retina and the lens. The NT-501 device continuously delivers CNTF into the vitreous cavity of the eye. It results in controlled, long-term delivery of CNTF. From the vitreous, CNTF can diffuse to the retina, which is the part of the eye affected by MacTel.

Based on promising results from the Phase 1 and Phase 2 trials, the Phase 3 clinical trial has begun. Participants enrolled in the Phase 3 trial will be followed for two years with a total of nine visits. This is a Treatment/Sham (placebo) study.

The Phase 1 and Phase 2 participants continue to be followed in a long-term extension study.

This Phase 3 study is registered with under two study IDs: NCT03319849 and NCT03316300.

The Phase 3 trial is currently enrolling.  If you are interested in participating in or would like more information about the Phase 3 clinical trial, contact LMRI