Serine and Fenofibrate Study in Patients With MacTel Type 2 (NCT04907084)
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)
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Emory University โ Atlanta, Georgia
Age range: 21 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (9 Sites)
- Emory University โ Atlanta, Georgia
- Kellogg Eye Center, University of Michigan โ Ann Arbor, Michigan
- Retina Associates of Cleveland โ Cleveland, Ohio
- Southeastern Retina Associates โ Knoxville, Tennessee
- Retina Consultants of Texas โ Bellaire, Texas
- Moran Eye Center, University of Utah โ Salt Lake City, Utah
- University of Washington โ Seattle, Washington
- The Eye Institute, Medical College of Wisconsin โ Milwaukee, Wisconsin
- Moorfields Eye Hospital โ London,
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Macular Telangiectasia Type 2
- A Study to Determine the Safety and Efficacy of NT-501 With MHFM โ Walnut Creek, California
Explore by condition: All Macular Telangiectasia Type 2 clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.