Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07457632 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusWithdrawn
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Withdrawn before enrolling Sponsor's reason: The study was terminated due to additional regulatory requirements that could not be completed within the established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. Enrollment target: estimated 69 to confirmed 0 · Primary endpoints: details revised at 1 of 4 entries · Study sites: 1 to 0 · 2 more Show 5 more changesShow less
    • Enrollment target: estimated 69 to confirmed 0
    • Primary endpoints: details revised at 1 of 4 entries
    • Study sites: 1 to 0
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 1 of 5 entries
  2. Start date: Jul 1, 2026 to Oct 1, 2026 Study title revisedv3 Show 1 more changeShow less
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  3. Primary endpoint(s) modified Start date: Apr 1, 2026 to Jul 1, 2026 · Secondary endpoints revised (5)v2 Show 2 more changesShow less
    • Start date: Apr 1, 2026 to Jul 1, 2026
    • Secondary endpoints revised (5)

    See this version in full on ClinicalTrials.gov ↗

  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07457632
Lead Sponsor University of Alabama at Birmingham
Conditions Diabetic Macular Edema (DME)
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov