drugset / Trial / NCT04907084

Serine and Fenofibrate Study in Patients With MacTel Type 2

NCT04907084

Phase 2 Active not recruiting 60 enrolled The Lowy Medical Research Institute Limited
RandomizedFactorialOpen-labelOther

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.

Timeline

Start
2022-04-07
Primary completion
2024-03
Completion
2024-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Fenofibrate Small molecule 160 mg Oral