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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 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
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 • NCT014628771%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking, or have taken in the past year, certain medications called fibrates.You are currently taking certain medications like blood thinners or specific drugs that can affect the study.You have had any type of cancer, except for basal cell carcinoma, in the past 5 years.You cannot come for the required check-up visits at the local lab.You are at least 21 years old, regardless of your gender.You have been diagnosed with MacTel type 2 in at least one eye and are enrolled in the Natural History Observation and Registry Study (NHOR).Your triglyceride levels are too high, even with treatment.You have untreated Hepatitis C, or a history of Hepatitis B, autoimmune hepatitis, or HIV.You currently have liver disease or high liver enzymes.You are allergic to fibrates or serine.You have a history of muscle problems caused by cholesterol-lowering medications.Your kidneys are not working well, as shown by high levels of creatinine in your blood or a low glomerular filtration rate (GFR).Your blood platelet count is less than 100,000 per microliter, or your hemoglobin levels are less than 10 g/dL, or you have a history of bleeding disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Fenofibrate 160 mg/day
- Group 2: Serine 200 mg/kg/day
- Group 3: Serine 200 mg/kg/day and Fenofibrate 160 mg/day
- Group 4: Serine 400 mg/kg/day
- Group 5: Serine 400 mg/kg/day and Fenofibrate 160 mg/day
- Group 6: No treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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