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Serine and Fenofibrate Study in Patients With MacTel Type 2
Sponsor: The Lowy Medical Research Institute Limited
Summary
This is a Phase 2a study of the effect of serine supplementation and fenofibrate treatment on serum deoxysphingolipid levels in patients with macular telangiectasia type 2 (MacTel). This study involves six arms. Participants will be randomly assigned to one of the following treatment groups: serine 200 mg/kg/day, serine 400 mg/kg/day, fenofibrate 160 mg/day, both serine 200 mg/kg/day and fenofibrate 160 mg/day, both serine 400 mg/kg/day and fenofibrate 160 mg/day, or no treatment (control group). Serum deoxysphingolipid levels will be used as the primary outcome, and safety will be evaluated. The participants will be followed for 10 weeks, with visits at Screening, Week 0, 3, 6 and 10.
Official title: Phase 2a Study of the Effect of Serine Supplementation and Fenofibrate Treatment on Serum Deoxysphinganine Levels in Patients With Macular Telangiectasia (MacTel) Type 2 (SAFE Study)
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
89
Start Date
2022-04-07
Completion Date
2024-09-30
Last Updated
2026-09-21
Healthy Volunteers
No
Conditions
Interventions
Serine
Powdered serine supplement (Dosed out individually per participant. Participant to mix with water and ingest orally)
Fenofibrate
Fenofibrate 160mg pill, taken orally
Locations (9)
Emory University
Atlanta, Georgia, United States
Kellogg Eye Center, University of Michigan
Ann Arbor, Michigan, United States
Retina Associates of Cleveland
Cleveland, Ohio, United States
Southeastern Retina Associates
Knoxville, Tennessee, United States
Retina Consultants of Texas
Bellaire, Texas, United States
Moran Eye Center, University of Utah
Salt Lake City, Utah, United States
University of Washington
Seattle, Washington, United States
The Eye Institute, Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Moorfields Eye Hospital
London, United Kingdom