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

NCT07457632 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2026-07-13

No results posted yet for this study

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. 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.

Conditions

  • Diabetic Macular Edema (DME)

Interventions

DIETARY_SUPPLEMENT

Tauroursodeoxycholate (TUDCA)

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

DIETARY_SUPPLEMENT

Traditional Chinese Medicine (mQJDHW)

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.

DRUG

placebo capsule

The placebo has no active ingredient.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Maria Grant, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07457632 on ClinicalTrials.gov