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Diabetic Macular Edema (DME)Phase 2NCT07457632

Integrative Liver-Targeted Therapy for Diabetic Macular Edema: Using "Tauroursodeoxycholate" or Traditional Chinese Medicine.

A Phase 2 study testing Tauroursodeoxycholate (TUDCA) and Traditional Chinese Medicine (mQJDHW) in people with Diabetic Macular Edema (DME), run by University of Alabama at Birmingham.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Diabetic macular edema is seen in the later stages of diabetic retinopathy with current conventional therapies targeting local vascular dysfunction. These therapies provide transient improvement in vision and are often uncomfortable to persons with diabetic macular edema and financially burdensome. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Diabetic Macular Edema (DME)
What is being tested?
Tauroursodeoxycholate (TUDCA) and Traditional Chinese Medicine (mQJDHW)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
1 Oct 2026to 31 Dec 2028
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age range 18-89 years
  • 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.
  • Written informed consent is provided.
  • Males and females
  • Routine laboratory study results CBC and Diff with bilirubin, aspartate aminotransferase and/or alanine aminotransferase, and creatinine within normal limits.

Who cannot join

  • History of difficulty controlling diabetes or hypertension with changes in medication in the last 3 months.
  • Eye having undergone YAG capsulotomy in the last 3 months.
  • Having other ocular surgeries in the last 6 months (examples include but not limited to cataract surgery, scleral buckle, trabeculectomies, etc.).
  • 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.
  • Chronic infectious disease (e.g. HIV, HCV)
  • Positive urine β-hCG test day of visit or a serum-hCG test within 48 hours prior to the initiation of the study
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  • Other ocular diseases or fundus diseases
  • Currently taking an anti-inflammatory medication (e.g. anti-inflammatory agents, glucocorticoids or other immune modulating medications);
  • 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.
  • 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.
  • Any degree of hepatic or renal insufficiency that in the investigator's judgement would pose a safety risk with TUDCA or mQJDHW.
  • 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.
  • 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.
  • Subjects with a current known infection or who are acutely ill.
  • Subjects with an autoimmune disease (i.e., Lupus, Rheumatoid Arthritis).
  • Subjects with thyroid disorders unless euthyroid at screening.
  • Subjects with cancer not in remission.
  • 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.
  • Limited mental capacity rendering the subject unable to provide written informed consent or comply with evaluation procedures.
  • History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols.
  • Use of any investigational drug/ nutraceuticals within 30 days prior to the baseline visit.

About this study

Official title: Integrative Liver-Targeted Therapy for Diabetic Macular Edema: Combining Tauroursodeoxycholate and Traditional Chinese Medicine.

Diabetic macular edema is seen in the later stages of diabetic retinopathy with current conventional therapies targeting local vascular dysfunction. These therapies provide transient improvement in vision and are often uncomfortable to persons with diabetic macular edema and financially burdensome. Diabetic macular edema, a complication of diabetes cannot be managed without addressing systemic inflammation. Liver metabolism and functions are implicated in diabetes and evidence suggests that hepatic metabolic dysfunctions are linked to the neuroinflammation and vascular dysfunctions observed in diabetic retinopathy. Nutraceutical supplements like Tauroursodeoxycholate (a bile acid) and modified Qi Ju Di Huang Wan (a traditional Chinese medicine formula) have been found to reduce hepatic and retinal oxidative stress, provide anti-apoptotic, anti-inflammatory, neuroprotective and hepatoprotective effects. This study will provide a non-invasive multi-targeted strategy for the management of diabetic macular edema.

Being tested
Tauroursodeoxycholate (TUDCA), Traditional Chinese Medicine (mQJDHW), placebo capsule

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tauroursodeoxycholate (TUDCA)Dietary supplement

    TUDCA is a hydrophilic taurine-conjugated form of Ursodeoxycholic acid (UDCA).

  • Traditional Chinese Medicine (mQJDHW)Dietary supplement

    The components of this formula are Tribulus terrestris, Paeonia lactiflora, Lycium chinensis, Angelica sinensis, Chrysanthemum morifolium, Paeonia suffruticosa, Dioscorea japonica, Cornus officinalis, Rehmannia glutinosa, Haliotis spp, Alisma plantago-aquatica and Dioscorea oppositifolia.

  • placebo capsuleDrug

    The placebo has no active ingredient.

Study groups in NCT07457632
Study groupRoleWhat they receive
Tauroursodeoxycholate (TUDCA) ArmActive comparatorTUDCA is a bile acid that is available as a supplement. It has been found to provide protection in neuroinflammatory and neurodegenerative diseases. Evidence links it to reducing retinopathy in pre-clinical studies.
Receives: Dietary Supplement: Tauroursodeoxycholate (TUDCA)
Traditional Chinese medicine (mQJDHW) ArmActive comparatorParticipants in this arm will be administered a standard dose of mQJDHW capsules twice daily for six months. mQJDHW, is a popular traditional Chinese medicine (TCM) formula used by TCM practitioners for managing eye diseases. It has been found to improve ocular health in anterior chamber diseases, uveitis, optic neuropathies and diabetic retinopathy. The various components of this formula, Tribulus terrestris, Paeonia lactiflora, Lycium chinensis, Angelica sinensis, Chrysanthemum morifolium, Paeonia suffruticosa, Dioscorea japonica, Cornus officinalis, Rehmannia glutinosa, Haliotis spp, Alisma plantago-aquatica and Dioscorea oppositifolia, have been found to provide neuroprotection, hepatoprotection, and reduce oxidative stress and neuroinflammation. Available in literature is evidence of the beneficial roles of this formula to systemic and retinal health.
Receives: Dietary Supplement: Traditional Chinese Medicine (mQJDHW)
Control (placebo) ArmPlacebo comparatorParticipants will receive capsules with no active ingredient twice daily for six months.
Receives: Drug: placebo capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in macrophage-like cell density (cells/mm²).

    Optical coherence tomography (OCT) images will be taken at each visit to visualize macrophage-like cells (MLC) seen in persons with DME. OCT images will be taken at the study visits and changes in the MLC density will be measured.

    Measured: Up to three months

  2. Change from baseline in best-corrected visual acuity (ETDRS letters).

    Each participant will have their best corrected visual acuity measured by Early Treatment of Diabetic Retinopathy study (ETDRS) chart.

    Measured: Up to three months

  3. Change from baseline in serum neuroinflammatory makers.

    Blood will be drawn and neuroinflammatory and hepatic makers will be assessed at each study visit

    Measured: Up to three months

  4. Change from baseline in serum hepatic biomarkers.

    Blood will be drawn and hepatic makers will be assessed at each study visit.

    Measured: Up to three months

Secondary outcomes (5)

  1. Change from baseline in macular central subfield thickness (µm).

    Participants will have optical coherence tomography imaging at each study visit that will measure macular central subfield thickness. Measuring the change from visit one to the last visit.

    Measured: Up to three months

  2. Changes from baseline in retinal peripheral capillary free zone (mm²).

    Each participant will have optical coherence tomography angiography (OCTA) to measure differences in retinal peripheral capillary free zone.

    Measured: Up to three months

  3. Changes from baseline in retinal foveal avascular zone (mm²).

    Each participant will have optical coherence tomography angiography to measure differences in retinal foveal avascular zone.

    Measured: Up to three months

  4. Changes from baseline in retinal capillary density (%).

    Each participant will have optical coherence tomography angiography to measure differences in retinal capillary density.

    Measured: Up to three months

  5. Changes from baseline in retinal non-perfusion zones (mm²).

    Each participant will have optical coherence tomography angiography to measure differences in retinal non-perfusion zones.

    Measured: Up to three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Why it stopped: The study was terminated due to additional regulatory requirements that could not be completed within the established academic timeline. As a result, continuation of the study was not feasible.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07457632
Sponsor's protocol ID
IRB-300016314
Other IDs
UAB Dept. of Ophthalmology
Status last verified
Sep 2026
First submitted
3 Mar 2026
Last updated
9 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tauroursodeoxycholate (TUDCA) and Traditional Chinese Medicine (mQJDHW) in people with Diabetic Macular Edema (DME), run by University of Alabama at Birmingham.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in macrophage-like cell density (cells/mm²). (time frame: Up to three months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07457632.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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