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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tauroursodeoxycholate (TUDCA) Arm | Active Comparator | TUDCA is a bile acid that is available as a supplement. It has been found to provide protection in neuroinflammatory and neurodegenerative diseases. Evidence links it to reducing retinopathy in pre-clinical studies. |
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| Traditional Chinese medicine (mQJDHW) Arm | Active Comparator | Participants in this arm will be administered a standard dose of mQJDHW capsules twice daily for six months. mQJDHW, is a popular traditional Chinese medicine (TCM) formula used by TCM practitioners for managing eye diseases. It has been found to improve ocular health in anterior chamber diseases, uveitis, optic neuropathies and diabetic retinopathy. The various components of this formula, 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, have been found to provide neuroprotection, hepatoprotection, and reduce oxidative stress and neuroinflammation. Available in literature is evidence of the beneficial roles of this formula to systemic and retinal health. |
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| Control (placebo) Arm | Placebo Comparator | Participants will receive capsules with no active ingredient twice daily for six months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tauroursodeoxycholate (TUDCA) | Dietary Supplement | TUDCA is a hydrophilic taurine-conjugated form of Ursodeoxycholic acid (UDCA). |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in macrophage-like cell density (cells/mm²). | 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. | Up to three months |
| Change from baseline in best-corrected visual acuity (ETDRS letters). | Each participant will have their best corrected visual acuity measured by Early Treatment of Diabetic Retinopathy study (ETDRS) chart. | Up to three months |
| Change from baseline in serum neuroinflammatory makers. | Blood will be drawn and neuroinflammatory and hepatic makers will be assessed at each study visit | Up to three months |
| Change from baseline in serum hepatic biomarkers. | Blood will be drawn and hepatic makers will be assessed at each study visit. | Up to three months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in macular central subfield thickness (µm). | Participants will have optical coherence tomography imaging at each study visit that will measure macular central subfield thickness. Measuring the change from visit one to the last visit. | Up to three months |
| Changes from baseline in retinal peripheral capillary free zone (mm²). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandra Owusu, OD | Contact | 205-222-2837 | owusus@uab.edu | |
| Sarbodeep Paul | Contact | 659-253-3319 | spaul5@uab.edu |
| Name | Affiliation | Role |
|---|---|---|
| Maria Grant, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35243 | United States |
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| Traditional Chinese Medicine (mQJDHW) | Dietary Supplement | 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. |
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| placebo capsule | Drug | The placebo has no active ingredient. |
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Each participant will have optical coherence tomography angiography (OCTA) to measure differences in retinal peripheral capillary free zone. |
| Up to three months |
| Changes from baseline in retinal foveal avascular zone (mm²). | Each participant will have optical coherence tomography angiography to measure differences in retinal foveal avascular zone. | Up to three months |
| Changes from baseline in retinal capillary density (%). | Each participant will have optical coherence tomography angiography to measure differences in retinal capillary density. | Up to three months |
| Changes from baseline in retinal non-perfusion zones (mm²). | Each participant will have optical coherence tomography angiography to measure differences in retinal non-perfusion zones. | Up to three months |
| ID | Term |
|---|---|
| C031655 | ursodoxicoltaurine |
| D008516 | Medicine, Chinese Traditional |
| ID | Term |
|---|---|
| D008518 | Medicine, East Asian Traditional |
| D008519 | Medicine, Traditional |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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