University of Alabama at Birmingham
Birmingham, Alabama, 35243, United States
Location contact
Sandra Owusu, OD
CONTACT
Sarbodeep Paul
CONTACT
NCT Number: NCT07457632
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 opening soon.
Get Notified18 year–89 year
All sexes
Interventional
Phase 2
Birmingham, Alabama, 35243, United States
Sandra Owusu, OD
CONTACT
Sarbodeep Paul
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Up to three months
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
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
Blood will be drawn and neuroinflammatory and hepatic makers will be assessed at each study visit
Time frame: Up to three months
Blood will be drawn and hepatic makers will be assessed at each study visit.
Time frame: Up to three months
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
Each participant will have optical coherence tomography angiography (OCTA) to measure differences in retinal peripheral capillary free zone.
Time frame: Up to three months
Each participant will have optical coherence tomography angiography to measure differences in retinal foveal avascular zone.
Time frame: Up to three months
Each participant will have optical coherence tomography angiography to measure differences in retinal capillary density.
Time frame: Up to three months
Each participant will have optical coherence tomography angiography to measure differences in retinal non-perfusion zones.
Contact information is provided by the study sponsor or research team.
Sandra Owusu, OD
CONTACT
Sarbodeep Paul
CONTACT
University of Alabama at Birmingham
Other
Integrative Liver-Targeted Therapy for Diabetic Macular Edema: Combining Tauroursodeoxycholate and Traditional Chinese Medicine.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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