Serine Fenofibrate Study

The Serine and Fenofibrate study (SAFE study) is a Phase 2a study to investigate the effect of serine and/or fenofibrate on deoxysphingolipid levels in patient serum.

Study rationale:  Research by LMRI scientists and collaborators determined that low serine levels play a role in MacTel, leading to elevated levels of toxic lipids (deoxysphingolipids).  The SAFE study will determine if serine supplementation and/or fenofibrate administration has an effect on serine and/or deoxysphingolipid levels in patient serum.

In this study, patients are randomly assigned to one of six groups:  no treatment, low dose serine, high dose serine, fenofibrate, low dose serine and fenofibrate, high dose serine and fenofibrate.  This is a 10-week study.

This study is registered with clinicaltrials.gov, Study ID NCT04907084

The study was conducted at several MacTel Registry sites.  See the clinicaltrials.gov page for details.  This study is closed.