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Fibrate

Serine + Fenofibrate for Macular Telangiectasia Type 2 (SAFE Trial)

Phase 2
Waitlist Available
Led By Mari A Gantner, PhD
Research Sponsored by The Lowy Medical Research Institute Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up blood draws from week 3, 6, and 10
Awards & highlights

Summary

This trial tests serine and fenofibrate on patients with MacTel to see if they can lower harmful blood fats linked to eye problems. Fenofibrate is known to reduce bad fats and increase good fats in the blood.

Eligible Conditions
  • Macular Telangiectasia Type 2

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~blood draws from week 3, 6, and 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and blood draws from week 3, 6, and 10 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety Assessment
Serum Deosxysphingolipid Levels
Secondary study objectives
Amino Acid Levels
Lipid Levels

Side effects data

From 2014 Phase 4 trial • 506 Patients • NCT01462877
1%
Nausea
1%
Alanine aminotransferase increased
1%
Aspartate aminotransferase increased
1%
Blood creatine phosphokinase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fenofibrate Arm

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Serine 400 mg/kg/day and Fenofibrate 160 mg/dayExperimental Treatment2 Interventions
Serine 400 mg/kg per day. To be taken once per day for 6 weeks. Exact dose dependent on participant's weight (in kg)). Fenofibrate 160 mg per day. To be taken once per day for 6 weeks.
Group II: Serine 400 mg/kg/dayExperimental Treatment1 Intervention
Serine 400 mg/kg per day. To be taken once per day for 6 weeks. Exact dose dependent on participant's weight (in kg)).
Group III: Serine 200 mg/kg/day and Fenofibrate 160 mg/dayExperimental Treatment2 Interventions
Serine 200 mg/kg per day. To be taken once per day for 6 weeks. Exact dose dependent on participant's weight (in kg)). Fenofibrate 160 mg per day. To be taken once per day for 6 weeks.
Group IV: Serine 200 mg/kg/dayExperimental Treatment1 Intervention
Serine 200 mg/kg per day. To be taken once per day for 6 weeks. Exact dose dependent on participant's weight (in kg)).
Group V: Fenofibrate 160 mg/dayExperimental Treatment1 Intervention
Fenofibrate 160 mg per day. To be taken once per day for 6 weeks.
Group VI: No treatmentActive Control1 Intervention
Control group: no investigational product taken
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fenofibrate
2018
Completed Phase 4
~6500

Find a Location

Who is running the clinical trial?

The Lowy Medical Research Institute LimitedLead Sponsor
5 Previous Clinical Trials
127 Total Patients Enrolled
1 Trials studying Macular Telangiectasia
9 Patients Enrolled for Macular Telangiectasia
Mari A Gantner, PhDPrincipal InvestigatorLowy Medical Research Institute

Media Library

Fenofibrate (Fibrate) Clinical Trial Eligibility Overview. Trial Name: NCT04907084 — Phase 2
Macular Telangiectasia Research Study Groups: Fenofibrate 160 mg/day, Serine 200 mg/kg/day, Serine 200 mg/kg/day and Fenofibrate 160 mg/day, Serine 400 mg/kg/day, Serine 400 mg/kg/day and Fenofibrate 160 mg/day, No treatment
Macular Telangiectasia Clinical Trial 2023: Fenofibrate Highlights & Side Effects. Trial Name: NCT04907084 — Phase 2
Fenofibrate (Fibrate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04907084 — Phase 2
~18 spots leftby Sep 2025
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