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.
Age range 18-89 years
Clinical diagnosis of diabetic retinopathy with diabetic macular edema (defined as CST greater than 250 and presence of microglia/macrophages on OCT) with a visual acuity between 20/32 and 20/200.
Written informed consent is provided.
Males and females
History of difficulty controlling diabetes or hypertension with changes in medication in the last 3 months.
Eye having undergone YAG capsulotomy in the last 3 months.
Having other ocular surgeries in the last 6 months (examples include but not limited to cataract surgery, scleral buckle, trabeculectomies, etc.).
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.
Parallel
Tauroursodeoxycholate (TUDCA)
Dietary supplementTUDCA is a hydrophilic taurine-conjugated form of Ursodeoxycholic acid (UDCA).
Traditional Chinese Medicine (mQJDHW)
Dietary supplementThe 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.
placebo capsule
DrugThe placebo has no active ingredient.
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.
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.
Change from baseline in serum neuroinflammatory makers.
Blood will be drawn and neuroinflammatory and hepatic makers will be assessed at each study visit
Change from baseline in serum hepatic biomarkers.
Blood will be drawn and hepatic makers will be assessed at each study visit.
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.
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.
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.
Changes from baseline in retinal capillary density (%).
Each participant will have optical coherence tomography angiography to measure differences in retinal capillary density.
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