Clinical Trial

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

Not Yet Recruiting Phase 2
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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.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-04-10
Trial Details
NCT Number NCT07457632
Lead Sponsor University of Alabama at Birmingham
Conditions Diabetic Macular Edema (DME)
Enrollment 69 participants
Start Date 2026-10-01
Primary Completion 2028-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-13