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COMPLETED
NCT04907084
PHASE2

Serine and Fenofibrate Study in Patients With MacTel Type 2

Sponsor: The Lowy Medical Research Institute Limited

View on ClinicalTrials.gov

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

Interventions

DIETARY_SUPPLEMENT

Serine

Powdered serine supplement (Dosed out individually per participant. Participant to mix with water and ingest orally)

DRUG

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