Clinical Trial

Serine and Fenofibrate Study in Patients With MacTel Type 2

Study acronym: SAFE
Active, Not Recruiting Phase 2
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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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2021-05-25; most recent amendment 2026-05-12.
Status change: Active, Not Recruiting → Completed 2026-05-12
Status change: Recruiting → Active, Not Recruiting 2024-03-12
Status change: Not Yet Recruiting → Recruiting 2022-06-13
Trial Details
NCT Number NCT04907084
Lead Sponsor The Lowy Medical Research Institute Limited
Conditions Macular Telangiectasia Type 2
Enrollment 60 participants
Start Date 2022-04-07
Primary Completion 2024-03 (estimated)
Study Completion 2024-03 (estimated)
Updated on ClinicalTrials.gov 2024-03-13