NCT04907084

Serine and Fenofibrate Study in Patients With MacTel Type 2

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)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The Lowy Medical Research Institute Limited · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Additional Procedures include: 1. Fasting blood work 2. Collection of microbiome samples

Conditions

• Macular Telangiectasia Type 2

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-04-07
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2021-05-28
• Last updated: 2024-03-13

Locations

9 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study