View clinical trials related to Diabetic Macular Edema.
Filter by:The VOYAGER study is a primary data collection, non-interventional, prospective, multinational, multicenter study. It is designed to collect real-world, long-term data to explore long-term effectiveness, safety, clinical insights, treatment patterns, and factors driving the treatment decisions among patients being treated with specified Roche ophthalmology products (Faricimab and Port Delivery System with Ranibizumab) in approved retinal indications (neovascular age-related macular degeneration [nAMD] and diabetic macular edema [DME]) in routine clinical practice. This study will not provide or make recommendations on use of any products including Roche products; treatment decisions will be determined by the treating physician and must be made independently to the decision to participate in this study. Participation in this study will not change or influence a patient's standard of care in any way.
The goal of this study is to evaluate the real-world outcomes of intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatment in diabetic macular edema (DME) patients.
The prevalence of diabetes mellitus has increased significantly in Hong Kong for the past decade [1]. Diabetic macular edema is one of the most common causes of vision loss in patients suffering from diabetes mellitus [3]. Before the introduction of anti-vascular endothelial growth factor agents, laser photocoagulation has been the mainstay treatment for patients with diabetic macular edema. There are two types of laser treatment modalities, namely focal laser, which can be applied either in a grid pattern over a region of macular edema or to selected microaneurysms, and subthreshold micropulse laser. Only one meta-analysis published in 2016 [16] had previously demonstrated superiority of micropulse laser over focal laser, while other studies showed no clinically significant differences between the two lasers. Nevertheless, micropulse laser had been proven to cause no structural changes to the retina and choroid, as opposed to focal laser. Optical coherence tomography angiography (OCT-A) is a new, non-invasive imaging technique that allows a clear, depth-resolved visualization of the retinal and choroidal microvasculature in the macular region [22]. A recent case series study [17] has demonstrated early changes of retinal vasculature on OCT-A images after micropulse laser for diabetic macular edema. Another cross-sectional study [18] showed choriocapillaries alterations in some of the patients after receiving focal laser. We would like to compare the changes of different OCT-A parameters for patients receiving either type of laser, and hence evaluating their efficacy. We propose to take OCT-A images for patients before laser, 1-, 3- and 6-months post-laser based on the results of a recent case series [17]. We will analyse the OCT-A images with MATLAB software and compare the changes in different parameters between both lasers.
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of D-4517.2 After Subcutaneous Administration in subjects with Neovascular (wet) Age-Related Macular Degeneration (AMD) or subjects with Diabetic Macular Edema (DME)
Diabetes affects over 37 million Americans and over 530 million people globally. Each diabetic patient needs at least one retinal exam per year starting immediately at the time of diagnosis if they have Type II diabetes (and starting at 5th year after disease onset if they have Type I diabetes). However, majority of diabetic patients do not get their eye exam due to multiple prohibitive factors such as cost, transportation, difficulty of taking time off from work, and inconvenience, amongst others. As a result, diabetes is the most common cause of visual impairment and blindness in working age adults in the United States and globally. Early detection via effective screening can prevent diabetes-related blindness. However, there are multiple barriers to screening. This prompted the development of RETINA-AI Galaxy™ v2.0, an automated Software as a Medical Device that screens for diabetic retinopathy in the primary care setting. This observational study was designed to validate the safety and efficacy of the RETINA-AI Galaxy™ Software-as-a-Medical-Device.
Anti-inflammatory or anti-angiogenic drugs play an ever- increasing role in the treatment of diabetic macular edema (DME). The drug delivery systems, such as injections of corticosteroid and or vascular endothelial growth factor (VEGF) antibodies into the vitreous cavity or slow release drug capsules surgically implanted in the eyes run the risk of surgical complications including infections, hemorrhages and cataracts and place a huge demand on eye care resources significantly increase the risk of cardiovascular events and death. A non-invasive drug delivery platform with steroid eye drops, reaching the back of the eye to treat DME and other retinal diseases would circumvent most of these problems. A novel drug delivery platform is required for ocular therapy. Oculis ehf. has developed a drug delivery platform, which is based on cyclodextrin nanoparticles that dissolve in the tear fluid to form water-soluble drug/cyclodextrin complex nanoparticles. Animal and initial clinical testing has shown the potential for this technology to increase the drug concentration in the eye tissues including the retina and therefore treat retinal diseases like DME.
The DRAGONS study is a non-interventional, prospective study that will 1. characterize disease state biomarker (including cytokines, KKS metabolites, and cell adhesion molecules) levels from aqueous humor of subjects with various stages of diabetic retinopathy (DR) and diabetic macular edema (DME) as well as other retinal pathologies, and 2. correlate a broad array of aqueous humor disease state biomarkers with DR severity, DME anti-vascular endothelial growth factor (VEGF) responsiveness, and other retinal pathologies.
Phase III clinical study of the efficacy and safety of 9MW0813 and aflibercept (EYLEA®) in patients with diabetic macular edema (DME) in a multicenter, randomized, double-blind, parallel active-controlled study.
A multicenter, randomized, double-blind, parallel-controlled phase I trial comparing the safety, pharmacokinetics and efficacy of 9MW0813 and aflibercept (EYLEA®) after a single dose in patients with diabetic macular edema (DME).
This is a multi-centered, open-labeled, single ascending-dose-cohort study to evaluate 4 dosing cohorts of AG-73305 administered by intravitreal injection in patients with diabetic macular edema (DME).