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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
69
TUDCA is a hydrophilic taurine-conjugated form of Ursodeoxycholic acid (UDCA).
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.
The placebo has no active ingredient.
University of Alabama at Birmingham
Birmingham, Alabama, United States
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Up to three months
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.
Time frame: Up to three months
Changes from baseline in retinal peripheral capillary free zone (mm²).
Each participant will have optical coherence tomography angiography (OCTA) to measure differences in retinal peripheral capillary free zone.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to three months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.