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Can serine and fenofibrate lower harmful fats in MacTel?

NCT ID NCT04907084

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · 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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

89 people

The number who actually took part.

Started

Apr 2022

Finished

Sep 2024

Lead sponsor

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

21 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Kellogg Eye Center, University of Michigan

    Ann Arbor, Michigan, 48105, United States

  • Moorfields Eye Hospital

    London, ECV2PD, United Kingdom

  • Moran Eye Center, University of Utah

    Salt Lake City, Utah, 84132, United States

  • Retina Associates of Cleveland

    Cleveland, Ohio, 44122, United States

  • Retina Consultants of Texas

    Bellaire, Texas, 77401, United States

  • Southeastern Retina Associates

    Knoxville, Tennessee, 37922, United States

  • The Eye Institute, Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • University of Washington

    Seattle, Washington, 98104, United States