Could a bile acid and herbal mix treat Diabetes-Related vision loss?
NCT ID NCT07457632
First seen Jun 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times
Summary
This study tests whether two dietary supplements—tauroursodeoxycholate (a bile acid) and a traditional Chinese medicine formula—can help people with diabetic macular edema, a vision-threatening complication of diabetes. The 69 participants will take the supplements or a placebo for several months. The goal is to see if this approach reduces eye inflammation and improves vision by targeting liver health, which may play a role in the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tauroursodeoxycholate (TUDCA) and a traditional Chinese medicine formula (modified Qi Ju Di Huang Wan)
- What this could lead to
- If it works, this could offer a non-invasive, multi-targeted treatment option for diabetic macular edema that addresses underlying inflammation rather than just local eye problems.
- What could go wrong
- This is an early phase 2 trial with only 69 participants, so results may not apply to everyone. The supplements may not improve vision or could cause 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
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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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About 69 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- 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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18 to 89 years
- 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. Age range 18-89 years 2. Clinical diagnosis of diabetic retinopathy with diabetic macular edema (defined as CST greater than 250 and presence of microglia/macrophages on OCT) with a visual acuity between 20/32 and 20/200. 3. Written informed consent is provided. 4. Males and females 5. Routine laboratory study results CBC and Diff with bilirubin, aspartate aminotransferase and/or alanine aminotransferase, and creatinine within normal limits. Exclusion Criteria: 1. History of difficulty controlling diabetes or hypertension with changes in medication in the last 3 months. 2. Eye having undergone YAG capsulotomy in the last 3 months. 3. Having other ocular surgeries in the last 6 months (examples include but not limited to cataract surgery, scleral buckle, trabeculectomies, etc.). 4. All women of childbearing potential must have a negative urine pregnancy test at the Screening Visit and throughout the study. Sexually active women participating in the study must use a medically acceptable form of contraception if they are not trying to get pregnant. 5. Chronic infectious disease (e.g. HIV, HCV) 6. Positive urine β-hCG test day of visit or a serum-hCG test within 48 hours prior to the initiation of the study 7. Other ocular diseases or fundus diseases 8. Currently taking an anti-inflammatory medication (e.g. anti-inflammatory agents, glucocorticoids or other immune modulating medications); 9. Use of cyclooxygenase-2 (COX-2) inhibitors for \< 6 months prior to study entry or dose changes after study entry. Limited as-needed use is permitted prior to study entry but not during the study. 10. Use of statins that cross the blood brain barrier such as atorvastatin will not be permitted during the study as they have been shown to reduce levels of pro-inflammatory cytokines. 11. Any degree of hepatic or renal insufficiency that in the investigator's judgement would pose a safety risk with TUDCA or mQJDHW. 12. Subjects who based on history or mental status examination have a significant risk of committing suicide, or who are homicidal or violent and who are in the Investigator's opinion in significant imminent risk of hurting others. 13. Subjects who have a medical condition that, in the investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety and efficacy during the course of the trial. 14. Subjects with a current known infection or who are acutely ill. 15. Subjects with an autoimmune disease (i.e., Lupus, Rheumatoid Arthritis). 16. Subjects with thyroid disorders unless euthyroid at screening. 17. Subjects with cancer not in remission. 18. Inability to attend scheduled study visits, plans for family relocation during the study, or any other criteria that the investigator may determine to be associated with inability to complete the study. 19. Limited mental capacity rendering the subject unable to provide written informed consent or comply with evaluation procedures. 20. History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols. 21. Use of any investigational drug/ nutraceuticals within 30 days prior to the baseline visit.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, 35243, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can one shot in the eye treat diabetic macular edema?
- Could a pill replace eye injections for diabetic vision loss?
- Can a new eye injection beat the current standard for diabetic vision loss?
- AI could predict which eye treatments work best for Diabetes-Related vision loss