Serine and Fenofibrate Study in Patients With MacTel Type 2 (NCT04907084) | Clinical Trial Compass
UnknownPhase 2
Serine and Fenofibrate Study in Patients With MacTel Type 2
United States60 participantsStarted 2022-04-07
Plain-language 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.
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. Signed and dated written informed consent obtained from the participant in accordance with the local regulations;
✓. Males/females 21 years of age or older;
✓. English speaking;
✓. Enrolled in the Natural History Observation and Registry Study (NHOR) and diagnosed with confirmed MacTel type 2 in at least one eye;
✓. Willing to use contraception, if applicable; and
✓. Willing to comply with study protocol and follow-up visits.
Exclusion criteria
✕. Participant is unable to provide informed consent;
✕. Participant is less than 21 years of age;
✕. Participant is currently taking, or has taken within four weeks prior to screening, a serine or glycine supplement;
✕. Participant is currently taking, or has taken within 12 months prior to screening, fibrates including clofibrate, ciprofibrate, bezafibrate, fenofibrate, and gemfibrozil;
What they're measuring
1
Serum Deosxysphingolipid Levels
Timeframe: blood draws from week 3, 6, and 10
2
Safety Assessment
Timeframe: Assessment at each study visit (reviewed at week 3, week 6, and week 10 of study)
Trial details
NCT IDNCT04907084
SponsorThe Lowy Medical Research Institute Limited