View clinical trials related to Diabetic Macular Edema.
Filter by:The objective of this study is to evaluate the safety and efficacy of APX3330 to treat diabetic retinopathy (DR) and diabetic macular edema (DME).
This Study (AFIL-IJZ-3002) is designed to evaluate the safety, efficacy and immunogenicity of MYL-1701P among a group of participants successfully completing MYL-1701P-3001 study.
Diabetic macular edema (DME) is an important cause of central vision impairment among people with diabetic retinopathy (DR), which can have a significant adverse effect on daily activities and quality of life. Diabetic patients with preexisting DME are at increased risk of worsening edema following cataract surgery. Previous studies also reported progression of DR after cataract surgery. Clinically significant DME is now classified into center-involved DME (CI-DME) and non center-involved DME (non-CI DME). Randomized clinical trials have established intravitreal antivascular endothelial growth factor (VEGF) therapy as first-line treatment for visual impairment from CI-DME and studies have addressed the influence of anti-VEGF therapy among patients with DME undergoing cataract surgery. However, for patients with non-CI DME before cataract surgery, whether anti-VEGF therapy is necessary at the end of surgery to prevent CI-DME is still clinically controversial. In order to evaluate the prophylactic effect of Conbercept (a recombinant fusion protein with high affinity to all VEGF isoforms and PIGF) intravitreal injection at the conclusion of cataract surgery for DME in patients with DR, the investigators will prospectively recruit 40 cataract patients with DR and non-CI DME and randomly assign these subjects into the study group (combined cataract surgery and intravitreal Conbercept injection, 20 cases) and the control group (cataract surgery alone, 20 cases). The primary outcomes include mean changes in central retinal thickness (CRT) and in diabetic retinopathy severity score (DRSS). The secondary outcomes include changes in best corrected visual acuity (BCVA), foveal avascular zone (FAZ), retinal vessel density (VD), the aqueous concentrations of VEGF, PIGF, interleukin- (IL-) 2, IL-5, IL-6, and IL-8.
Obstructive sleep apnea (OSA) is characterized by intermittent nocturnal hypoxemia, frequent arousals, fragmented sleep and daytime sleepiness. It has been shown to increase the risk of cardiac and vascular disease through multiple mechanisms including sympathetic hyperactivity, metabolic dysregulation, and activation of oxidative stress and inflammatory pathways. Diabetic retinopathy is a leading cause of blindness in the working age group, affecting 93 million people worldwide. Diabetic macular edema (DME) is a sight threatening complication and the most common cause of visual loss in patients with diabetes. OSA is frequently associated with diabetes with prevalence ranging from 23 to 86%. However, the relationship between OSA and DME is not well defined. The retina is especially susceptible to hypoxia, being one of the most metabolically active tissues. Many of the same inflammatory mediators have also been found to be elevated in patients with diabetic macular edema, including VEGF, VCAM-1 and IL-6. There has been no previous study examining the biochemical impact of OSA on patients with DME. We aim to explore this relationship by examining the differences in inflammatory markers expressed in patients with DME who have undergone an overnight sleep study, which is considered the gold standard diagnostic tool in OSA.
This was an open-label, multi-center, FIH study with a single ascending dose (SAD) design that assessed the safety, tolerability and pharmacokinetics (PK) of a single IVT dose of MHU650 in up to 24 participants with macular edema.
DMO is the most common cause of visual loss in people with diabetes. Regular injections of bevacizumab (Avastin) given as frequently as every month remain the current standard of care for centre-involving DMO; however, this regimen is impractical for many Aboriginal patients. Using Ozurdex implants every 3-6 months could be as effective as the currently used Avastin injections. In order to address this real-world problem, this study seeks to investigate whether it is possible to safely use a long-acting steroid preparation such as the dexamethasone IVT implant (Ozurdex) to manage DMO in Aboriginal patients living in Western Australia.
This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept in participants with treatment-naïve DME.
This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept in participants with treatment-naïve DME.
This is an exploratory, prospective, multicenter, open-label, single-arm, interventional, Phase IIb study designed to explore the associations over time between clinical assessments, multimodal imaging assessments, aqueous humor (AH) biomarker patterns, and genetic polymorphisms in participants with diabetic macular edema (DME) who are treated with faricimab.
The primary objective is to investigate and characterize the intraocular pharmacokinetics (free and bound) following intravitreal aflibercept injection (IAI) in vitrectomized and non-vitrectomized eyes with diabetic macular edema The secondary objectives are to - - Investigate and characterize plasma concentrations (free and bound) following injections of intravitreal aflibercept in vitrectomized and non-vitrectomized eyes with diabetic macular edema - Correlate with changes in ocular concentration of drug over 12 months - - change in Best Corrected Visual Acuity (BCVA) - change in Central Retinal Thickness (CRT) - change in Diabetic Retinopathy Severity Scale (DRSS) - changes observed on Ocular coherence tomography angiography (OCT-A) - number of injections - Evaluate ocular and systemic safety of intravitreal aflibercept - Additional plasma and anterior chamber (AC) fluid cytokine analysis will be performed if sufficient samples are available