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.
Additional Procedures include: 1. Fasting blood work 2. Collection of microbiome samples
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
60
Powdered serine supplement (Dosed out individually per participant. Participant to mix with water and ingest orally)
Fenofibrate 160mg pill, taken orally
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
Serum Deosxysphingolipid Levels
Any changes in serum deoxysphingolipid levels measured (determined via serum sample) at 3 weeks, 6 weeks, and/or 10 weeks when compared with baseline levels measured in week 0
Time frame: blood draws from week 3, 6, and 10
Safety Assessment
Safety assessment measured via examined AEs and SAEs (during study visits) and via participant self-reported AEs and SAEs that occurred between visits
Time frame: Assessment at each study visit (reviewed at week 3, week 6, and week 10 of study)
Lipid Levels
Any changes in lipid levels measured (determined via blood tests) at 3 weeks, 6 weeks, and/or 10 weeks when compared with baseline levels measured at screening
Time frame: blood draws from week 3, 6, and 10
Amino Acid Levels
Any changes in amino acid levels measured (determined via blood tests) at 3 weeks, 6 weeks, and/or 10 weeks when compared with baseline levels measured at screening
Time frame: blood draws from week 3, 6, and 10
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