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Clinical Trial 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.


Clinical Trial Description

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


Study Design


Related Conditions & MeSH terms


NCT number NCT04907084
Study type Interventional
Source The Lowy Medical Research Institute Limited
Contact
Status Active, not recruiting
Phase Phase 2
Start date April 7, 2022
Completion date March 2024

See also
  Status Clinical Trial Phase
Completed NCT03316300 - A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2 - Protocol A Phase 3
Completed NCT03319849 - A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2 Phase 3
Completed NCT04729972 - Safety Study to Evaluate Bilateral CNTF Implants in Subjects With MacTel Type 2 Phase 2
Completed NCT01949324 - A Phase 2 Multicenter Randomized Clinical Trial of CNTF for MacTel Phase 2
Not yet recruiting NCT06397131 - A Study to Determine the Safety and Efficacy of NT-501 With MHFM Phase 3