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Serine and Fenofibrate Study in Patients With MacTel Type 2

NCT04907084 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-03-13

No results posted yet for this study

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.

Conditions

  • Macular Telangiectasia Type 2

Interventions

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

Sponsors & Collaborators

  • The Lowy Medical Research Institute Limited

    lead OTHER

Principal Investigators

  • Mari A Gantner, PhD · Lowy Medical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-07
Primary Completion
2024-03-31
Completion
2024-03-31
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04907084 on ClinicalTrials.gov