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NCT04907084 · ClinicalTrials.gov registry record · Phase 2
Serine and Fenofibrate Study in Patients With MacTel Type 2
A Phase 2 study of Macular Telangiectasia Type 2, sponsored by The Lowy Medical Research Institute Limited.
- Active
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 9
- Study locations
NCT04907084 is a Phase 2 study of Macular Telangiectasia Type 2 that is active but no longer recruiting, run by The Lowy Medical Research Institute Limited. The registered enrollment target is 60 participants. The trial reports 9 study locations across 9 states.
The verdict
NCT04907084, a Phase 2 study of Macular Telangiectasia Type 2, is active but no longer recruiting, sponsored by The Lowy Medical Research Institute Limited.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 9
- Study locations
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 Studied
Interventions
- DRUG Fenofibrate
- DIETARY_SUPPLEMENT Serine
Study Locations (9)
Georgia
- Emory University - Atlanta
Michigan
- Kellogg Eye Center, University of Michigan - Ann Arbor
Ohio
- Retina Associates of Cleveland - Cleveland
Tennessee
- Southeastern Retina Associates - Knoxville
Texas
- Retina Consultants of Texas - Bellaire
Utah
- Moran Eye Center, University of Utah - Salt Lake City
Washington
- University of Washington - Seattle
Wisconsin
- The Eye Institute, Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-04-07 |
| Est. Completion | 2024-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04907084
The ClinicalTrials.gov registry entry for NCT04907084 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Lowy Medical Research Institute Limited, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Macular Telangiectasia Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Fenofibrate is the first listed.
NCT04907084 reports 9 study locations spanning 9 distinct geographic areas - top geographies include Georgia, Michigan, Ohio.
Frequently Asked Questions
What is clinical trial NCT04907084 about?
NCT04907084 is a clinical study titled "Serine and Fenofibrate Study in Patients With MacTel Type 2". 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 ...
What is the current status of trial NCT04907084?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2022-04-07. Estimated completion is 2024-03.
What conditions does trial NCT04907084 study?
This clinical trial studies the following conditions: Macular Telangiectasia Type 2.
What interventions are being tested in trial NCT04907084?
The interventions under investigation include: Fenofibrate (DRUG), Serine (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04907084?
This trial is sponsored by The Lowy Medical Research Institute Limited, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04907084 being conducted?
This trial has 9 study locations across Georgia, Michigan, Ohio, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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