Tauroursodeoxycholate + Traditional Chinese Medicine for Diabetic Macular Edema

SO
SP
Overseen BySarbodeep Paul
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new treatments for diabetic macular edema, a condition that can blur vision in some people with diabetes. It tests two treatments: Tauroursodeoxycholate (TUDCA, a bile acid supplement) and a traditional Chinese medicine formula, a mix of herbs known to support eye and liver health. The goal is to determine if these treatments can reduce inflammation and improve eye health without the discomfort and cost of current therapies. Individuals with diabetic retinopathy, an eye condition related to diabetes, who experience blurred vision might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

Yes, you may need to stop taking certain medications. The trial excludes participants currently taking anti-inflammatory medications, COX-2 inhibitors, and certain statins. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In earlier studies, Tauroursodeoxycholate (TUDCA) has shown potential for improving eye health. Research suggests that TUDCA can protect eye cells from damage caused by high sugar levels, common in diabetes, and might help with issues like diabetic macular edema. Tests in animals and cells have noted only a few side effects, indicating it is generally well-tolerated.

Traditional Chinese Medicine (TCM), specifically a formula called mQJDHW, has also been studied for its eye health benefits. Research shows that this formula can improve eye health and reduce inflammation. Although detailed safety information is limited, TCM has been used for many years with reports of few side effects, suggesting it might be safe to use.

Both TUDCA and mQJDHW show potential benefits with minimal side effects reported in studies. However, since this trial is in an early stage, more human data is needed to confirm their safety.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for diabetic macular edema because they offer novel approaches compared to standard medications like anti-VEGF injections and corticosteroids. Tauroursodeoxycholate (TUDCA) is unique as it is a bile acid supplement that targets neuroinflammation and neurodegeneration, potentially reducing retinopathy. Meanwhile, the Traditional Chinese Medicine formula mQJDHW combines natural ingredients known for enhancing ocular health and providing neuroprotection. These treatments could offer alternative or complementary options to current therapies by addressing underlying oxidative stress and inflammation differently.

What evidence suggests that this trial's treatments could be effective for diabetic macular edema?

Research has shown that Tauroursodeoxycholate (TUDCA), which participants in this trial may receive, benefits eye health. Studies have found that TUDCA can protect retinal cells, slow damage, and reduce cell death, which is crucial for managing diabetic macular edema. Early results suggest it helps maintain the retina's structure and may reduce retinal degeneration.

Similarly, Traditional Chinese Medicine (mQJDHW), another treatment option in this trial, has been used to support eye health by reducing inflammation and oxidative stress, which can worsen diabetic eye issues. Research indicates that mQJDHW can protect the eyes and decrease inflammation. Together, these treatments aim to address diabetic macular edema by tackling both local and overall health concerns.12367

Who Is on the Research Team?

MG

Maria Grant, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults aged 18-89 with diabetic macular edema and certain vision levels. Participants must have stable diabetes, normal liver and kidney tests, and no recent eye surgeries or other major health issues like infections, autoimmune diseases, or cancer. Women of childbearing age must use contraception.

Inclusion Criteria

I have diabetic retinopathy with macular edema and my vision is between 20/32 and 20/200.
Written informed consent is provided
I am male or female.
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Exclusion Criteria

I had a YAG laser eye procedure within the past 3 months.
I have had eye surgery in the past 6 months.
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
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either mQJDHW capsules, TUDCA supplements, or placebo twice daily for six months

24 weeks
Monthly visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Tauroursodeoxycholate (TUDCA)
  • Traditional Chinese Medicine (mQJDHW)

Trial Overview

The study compares the effects of Tauroursodeoxycholate (TUDCA), a traditional Chinese medicine formula (mQJDHW), and placebo capsules in people with diabetic macular edema to see if these non-invasive treatments can help manage the condition by targeting inflammation through liver function.

How Is the Trial Designed?

3

Treatment groups

Active Control

Placebo Group

Group I: Traditional Chinese medicine (mQJDHW) ArmActive Control1 Intervention
Group II: Tauroursodeoxycholate (TUDCA) ArmActive Control1 Intervention
Group III: Control (placebo) ArmPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Citations

Tauroursodeoxycholic Acid Protects Retinal and Visual ... - PMC

Early TUDCA treatment ameliorated a-wave, b-wave, and OP2 deficits. Late TUDCA treatment showed reduced preservation effects compared to early treatment.

Neuroprotective Effect of Tauroursodeoxycholic Acid (TUDCA ...

Both in vitro and in vivo data suggested that TUDCA could effectively delay degeneration and apoptosis of retinal neurons, preserve retinal structure and ...

Integrative Liver-Targeted Therapy for Diabetic Macular ...

This study will provide a non-invasive multi-targeted strategy for the management of diabetic macular edema. Official Title. Integrative Liver-Targeted Therapy ...

Neuroprotective Effect of Tauroursodeoxycholic Acid (TUDCA ...

Both in vitro and in vivo data suggested that TUDCA could effectively delay degeneration and apoptosis of retinal neurons, preserve retinal ...

Neuroprotective Effects of Tauroursodeoxicholic Acid ...

Overall, our results show that the ability of TUDCA to protect retinal tissue from degeneration is broad, affecting multiple retinal cell types ...

Tauroursodeoxycholic Acid Confers Protection Against ...

Tauroursodeoxycholic acid (TUDCA) has been shown to protect against oxidative damage in retinal pigment epithelial (RPE) cells.

Tauroursodeoxycholic acid protects retinal neural cells ...

In conclusion, TUDCA protected retinal neural cell cultures from cell death induced by elevated glucose concentration, decreasing mito-nuclear translocation of ...