Ignite Creation Date:
2024-05-06 @ 2:37 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04378972
Status:
COMPLETED
Last Update Posted:
2020-05-07
First Post:
2020-05-04
Brief Title:
Anti-inflammatory Effect of Curcumin Homotaurine Vitamin D3 on Human Vitreous in Patients With Diabetic Retinopathy
Sponsor:
University of Molise
Organization:
University of Molise
Study Overview
Official Title:
Analysis of Soluble Mediators of Inflammation and Angiogenesis in the Vitreous of Patients With Diabetic Retinopathy Treated With CurcuminHomotaurineVit D3
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dosage of pro-inflammatory cytokines and soluble mediators TNFα IL6 IL2 and PDGF-AB performed on 25 vitreous biopsies taken from patients with diabetic retinopathy and treated with increasing doses of curcumin 05uM and 1uM with or without homotaurine 100uM and vitamin D3 50nM
Detailed Description:
Diabetic retinopathy is one of the most common complications of diabetes mellitus and is a leading cause of vision loss and blindness in the working-age population worldwide DR is being recognized as a neurodegenerative disease of the retina as opposed to previously considered solely as a microvascular disease Progressive blindness is due to the long-term accumulation of pathological abnormalities in the retina of hyperglycemic patients In the initial phase non-proliferative diabetic retinopathy NPDR is almost asymptomatic with the onset of microhemorrhagic and microischemic episodes and an increase in vascular permeability Subsequently the progression of the disease is accompanied by the onset of a chronic inflammatory state and neovascularization in a vicious circle that feeds and determines the accumulation of damage to the retina through hypoxia oxidative stress and widespread neurodegeneration Among metabolites hyperglycemia is known to be the major factor which activates several metabolic pathways harmful for retina Moreover an increased level of glutamate has been reported in the diabetic retina and also in the vitreous of diabetic patients suggesting a neurotoxic role of glutamate which may damage retinal neurons and especially retinal ganglion cells by excitotoxicity In proliferative diabetic retinopathy PDR vitreous humor undergoes structural and molecular changes with changes also in composition which play a central role in supporting disease progressionThe vitreous 4 ml in volume is a transparent gel-like structure which fills the space between the lens and the retina It is composed of 98-99 of water with traces of cations ions proteins mainly collagen and polysaccharides such as hyaluronic acid In PDR patients undergoing pars plana vitrectomy vitreous samples are characterized by altered levels of bioactive molecules with pro-angiogenic proinflammatory and neuromodulatory activities So it is clear that the vitreous acts as a reservoir of soluble signaling mediators that could exacerbate retinal damage On the other hand the vitreous obtained from patients with PDR can be a powerful tool to evaluate the anti-angiogenic anti-inflammatory activity of new biomolecules that could be potential candidates for the treatment of diabetic vitreoretinopathy Currently PDR is treated with laser photocoagulation vitreoretinal surgery or intravitreal injection of drugs targeted to the vascular endothelial growth factor VEGF and steroid agentsHowever these protocols are effective in the short term cause side effects and above all are indicated only for advanced stages of the disease So noninvasive nondestructive and longer-duration treatment options are also needed Recently research efforts have been made to identify neuroprotective drugs able to prevent visual field loss and preserve visual function and a promising alternative for the treatment of early-stage NPDR comes from nutraceuticals In fact in vitro and in vivo studies have revealed that a variety of nutraceuticals has important antioxidant and anti-inflammatory properties that can compromise the first diabetes-driven molecular events that cause vitreoretinopathy acting upstream of the disease Based on the results of several investigations it is reasonable to assert that a single constituent that affects one target has limited efficacy in preventing the progression of multifactorial diseases A large body of research revealed that the use of a combination of compounds with synergistic multitarget effects may offer a more powerful approach for disease prevention including retinal neurodegeneration In experimental models of retinal neurodegeneration it has been shown that cotreatment of citicoline and homotaurine has a direct neuroprotective effect on primary retinal cells exposed to glutamate toxicity and HG levels Glutamate-induced excitotoxicity is implicated in the pathophysiology of several degenerative diseases of the retina including glaucoma Moreover HG-induced neurotoxicity is a characteristic of diabetic retinopathy Curcumin a yellowish non-flavonoid polyphenol that constitutes the main active compound of Curcuma longa is widely known for its antioxidant and anti-inflammatory properties Many studies have also described its marked protective effect on retinal cells against oxidative stress and inflammation Lastly vitamin D levels appeared to be lower in diabetes mellitus type 2 patients and this could have therapeutic implications Therefore the aim of the investigators study is to analyze the soluble mediators of inflammation and angiogenesis in the vitreous of patients with diabetic retinopathy treated with homotaurine curcumin and vitamin D3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None