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This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from macular edema and other disorders of the retina, choroid and vitreous.
This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from macular edema and other disorders of the retina, choroid and vitreous. Numerous studies have documented the anti-inflammatory activity of Dexamethasone in macular edema associated with diabetes, branch retinal vein occlusion, and non-infectious posterior uveitis. The investigators hypothesize that Episcleral Dexamethasone is safe, tolerable and that its anti-inflammatory activity will interface with the pro-inflammatory cascade associated with macular edema due to diabetes, surgery, trauma, vein occlusions, uveitis and retinal degeneration to improve visual structure and function. The investigators hypothesize that Episcleral Dexamethasone is safe, tolerable and that its anti-inflammatory activity will reduce macular edema and improve vision. The investigator's objective is to primarily assess the safety, tolerability and pharmacokinetics of Episcleral Dexamethasone in patients with macular edema; to secondarily assess efficacy in reducing macular edema and improving visual structure and function. The main outcome of the study is safety assessment. Secondary outcomes are assessment of visual acuity and anatomical changes in the macula as measured via optical coherence tomography (OCT) and fluorescein angiogram.
Stanford Medicine Ophthalmology
Targeted Therapy Technologies, LLC
Published on BioPortfolio: 2019-10-15T11:11:15-0400
This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from refractory diabetic macular edema.
This phase I trial will assess primarily the safety and secondarily the anti-inflammatory and anti-neovascular effect of Episcleral Celecoxib in patients suffering from macular edema and o...
Purpose: to determine the impact of dexamethasone solution - 4mg/ml in the short term treatment of diabetic macular edema (DME). Design: phase I- II, prospective, randomized, intervention...
This study seeks to evaluate the effect of the intravitreal 0.7mg dexamethasone implant on central macular thickness and visual acuity in those patients with persistent macular edema after...
Corticosteroids, whether injected peri- or intra-ocularly, remain indispensable tools of the therapeutic arsenal in treating inflammatory macular edema. However, a few years ago, only tria...
: To investigate the incidence of macular edema after pars plana vitrectomy (PPV) for rhegmatogenous retinal detachment (RRD) repair, the factors affecting its development and the efﬁcacy of intravi...
To analyze the visual outcome after early switch to dexamethasone (DEX) in eyes with diabetic macular edema previously treated with ranibizumab (RNB), based on structural spectral-domain optical coher...
To determine the characteristics of diabetic macular edema (DME) patients refractory to intravitreal bevacizumab (IVB) treatments and an additional dexamethasone implant.
To investigate the efficacy of single dose intravitreal dexamethasone implant in patients with diabetic macular edema (DME) resistant to anti-VEGF therapy.
To assess and compare early changes in neuroinflammatory and vascular parameters in diabetic macular edema (DME) with subfoveal neuroretinal detachment (SND) after treatment with intravitreal dexameth...
Fluid accumulation in the outer layer of the MACULA LUTEA that results from intraocular or systemic insults. It may develop in a diffuse pattern where the macula appears thickened or it may acquire the characteristic petaloid appearance referred to as cystoid macular edema. Although macular edema may be associated with various underlying conditions, it is most commonly seen following intraocular surgery, venous occlusive disease, DIABETIC RETINOPATHY, and posterior segment inflammatory disease. (From Survey of Ophthalmology 2004; 49(5) 470-90)
A form of MACULAR DEGENERATION also known as dry macular degeneration marked by occurrence of a well-defined progressive lesion or atrophy in the central part of the RETINA called the MACULA LUTEA. It is distinguishable from WET MACULAR DEGENERATION in that the latter involves neovascular exudates.
Specialized ophthalmic technique used in the surgical repair and or treatment of disorders that include retinal tears or detachment; MACULAR HOLES; hereditary retinal disease; AIDS-related retinal infections; ocular tumors; MACULAR DEGENERATION; DIABETIC RETINOPATHY; and UVEITIS.
An anti-inflammatory 9-fluoro-glucocorticoid.
Abnormal fluid accumulation in TISSUES or body cavities. Most cases of edema are present under the SKIN in SUBCUTANEOUS TISSUE.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
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