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NCT07457632 · ClinicalTrials.gov registry record · Phase 2
Integrative Liver-Targeted Therapy for Diabetic Macular Edema: Combining Tauroursodeoxycholate and Traditional Chinese Medicine.
A Phase 2 study, sponsored by University of Alabama at Birmingham.
- Not yet
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
NCT07457632: Clinical Trial Phase 2 study, sponsored by University of Alabama at Birmingham.
NCT07457632 is a Phase 2 study that has not yet begun recruiting, run by University of Alabama at Birmingham. The registered enrollment target is 69 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07457632, a Phase 2 study, has not yet begun recruiting, sponsored by University of Alabama at Birmingham.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
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.
Primary Outcome
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.
Interventions
- DRUG placebo capsule
- DIETARY_SUPPLEMENT Tauroursodeoxycholate (TUDCA)
- DIETARY_SUPPLEMENT Traditional Chinese Medicine (mQJDHW)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 2 |
What is known before NCT07457632 opens enrollment
NCT07457632 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo capsule is the first listed.
NCT07457632 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07457632 about?
NCT07457632 is a clinical study titled "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. ...
What is the current status of trial NCT07457632?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2026-07-01. Estimated completion is 2028-12-31.
What interventions are being tested in trial NCT07457632?
The interventions under investigation include: placebo capsule (DRUG), Tauroursodeoxycholate (TUDCA) (DIETARY_SUPPLEMENT), Traditional Chinese Medicine (mQJDHW) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT07457632?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07457632's enrollment target sits among peer trials
69 965th of 2000 higher than 1,034 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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