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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ blood draws from week 3, 6, and 10

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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