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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

SAFE Trial Summary

This trial is studying the effect of two drugs, serine and fenofibrate, on a specific type of fat found in the blood of people with a condition called macular telangiectasia type 2.

Eligible Conditions
  • Macular Telangiectasia Type 2

SAFE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety Assessment
Serum Deosxysphingolipid Levels
Secondary outcome measures
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

SAFE 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently being recruited for this clinical trial?

"This clinical trial is currently seeking participants, as reported on clinicaltrials.gov. The original posting date for this trial was April 7th, 2022 and it was last edited on November 3rd, 2022."

Answered by AI

Is it true that some people are allergic to Serine?

"While there is some data indicating that Serine may be safe, it is still in Phase 2 of clinical trials and has not yet been proven effective. Therefore, it received a score of 2."

Answered by AI

Are there other drugs that have been tested in combination with Serine?

"Currently, there are 9 ongoing clinical trials researching the efficacy of Serine. Out of these 9 trials, 5 have progressed to Phase 3. Additionally, while some of these trials originated in Xi'an, Shaanxi; research is being conducted at 128 locations worldwide."

Answered by AI

What do doctors usually prescribe Serine for?

"Conditions such as hypertriglyceridemia, severe fredrickson type v hypertriglyceridemia, and dyslipidemias can be managed through serine treatment."

Answered by AI

How many people are expected to enroll in this trial?

"Yes, this is an ongoing clinical trial that was first posted on April 7th, 2020. The latest update to the study occurred on November 3rd, 2020. They are currently recruiting for 60 participants from 4 different sites."

Answered by AI

In how many diverse locations is this experiment being carried out?

"Currently, this study is taking place at Retina Associates of Cleveland in Ohio, Kellogg Eye Center associated with the University of Michigan in Ann Arbor, The Eye Institute connected to the Medical College of Wisconsin in Milwaukee, and 4 other locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Serine and Fenofibrate Study in Patients With MacTel Type 2
2022. "Serine and Fenofibrate Study in Patients With MacTel Type 2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04907084.
~20 spots leftby May 2025
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