Can serine and fenofibrate lower harmful fats in MacTel?
NCT ID NCT04907084
First seen Sep 21, 2026 ยท Last updated Sep 21, 2026
Summary
Researchers are testing whether serine supplements and fenofibrate can reduce levels of deoxysphingolipids, which are harmful fats linked to macular telangiectasia type 2 (MacTel). Adults with confirmed MacTel type 2 join one of six groups: different doses of serine, fenofibrate alone, serine plus fenofibrate, or no treatment. The study measures changes in these fats and checks safety over 10 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- serine dietary supplement and fenofibrate
- What this could lead to
- If it works, this could offer a way to lower the harmful deoxysphingolipids linked to MacTel type 2 and possibly slow the disease.
- What could go wrong
- This is an early-phase trial with 89 participants, so it may not show a clear benefit or may not generalise to all MacTel patients. Fenofibrate can cause muscle or liver problems, and serine is generally well tolerated but may have side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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89 people
The number who actually took part.
- Started
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Apr 2022
- Finished
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Sep 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Signed and dated written informed consent obtained from the participant in accordance with the local regulations; 2. Males/females 21 years of age or older; 3. English speaking; 4. Enrolled in the Natural History Observation and Registry Study (NHOR) and diagnosed with confirmed MacTel type 2 in at least one eye; 5. Willing to use contraception, if applicable; and 6. Willing to comply with study protocol and follow-up visits. Exclusion Criteria: 1. Participant is unable to provide informed consent; 2. Participant is less than 21 years of age; 3. Participant is currently taking, or has taken within four weeks prior to screening, a serine or glycine supplement; 4. Participant is currently taking, or has taken within 12 months prior to screening, fibrates including clofibrate, ciprofibrate, bezafibrate, fenofibrate, and gemfibrozil; 5. Participant is currently taking an anticoagulant, colchicine, cyclosporine, tacrolimus or bile acid binding resins; 6. Participant has known allergy to fibrates and/or serine; 7. Participant has a known history of clinically significant myopathy or myalgia related to cholesterol-lowering drugs; 8. Participant has active liver disease and/or elevated liver enzymes\*; 9. Participant has renal dysfunction as evidenced by elevated serum creatinine\* and/ or glomerular filtration rate (GFR) less than 90 mL/min; 10. Participant has thrombocytopenia as evidenced by a platelet count below 100,000 per microliter, anemia as evidenced by hemoglobin levels below 10 g/dL, or history of bleeding disorder; 11. Participant has a history of gallbladder disease or has had a cholecystectomy; 12. Participant has triglyceride levels greater than 400 mg/dL on treatment, or greater than 700 mg/dL on no treatment; 13. Participant has untreated/uncured Hepatitis C, or a history of Hepatitis B, autoimmune hepatitis, or HIV; 14. Participant has had any malignancies within the last 5 years (not including basal cell carcinoma); 15. Participant has ever been enrolled in a clinical trial involving ciliary neurotrophic factor (CNTF) treatment; 16. Participant is currently enrolled in another clinical trial that involves treatment or participated in one within the last 30 days; 17. Participant is pregnant, breastfeeding or planning a pregnancy; 18. Participant is medically unable to comply with study procedures or follow-up visits; 19. Participant has, in the opinion of the Investigator, any physical or mental condition that would increase the patient's risk of participation in the study or may interfere with the study procedures, evaluations and outcome assessments; or 20. Patient is unavailable for follow-up visits. \*based on reference range for the local laboratory used
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Emory University
Atlanta, Georgia, 30322, United States
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Kellogg Eye Center, University of Michigan
Ann Arbor, Michigan, 48105, United States
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Moorfields Eye Hospital
London, ECV2PD, United Kingdom
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Moran Eye Center, University of Utah
Salt Lake City, Utah, 84132, United States
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Retina Associates of Cleveland
Cleveland, Ohio, 44122, United States
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Retina Consultants of Texas
Bellaire, Texas, 77401, United States
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Southeastern Retina Associates
Knoxville, Tennessee, 37922, United States
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The Eye Institute, Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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University of Washington
Seattle, Washington, 98104, United States