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Diabetic Macular Edema clinical trials

View clinical trials related to Diabetic Macular Edema.

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NCT ID: NCT06332690 Recruiting - Clinical trials for Diabetic Macular Edema

OCT and OCT-Angiography Biomarkers of Treatment Response to Dexamethasone Implant in Macular Edema Due to Retinal Vascular Diseases - DME and RVO

Start date: October 17, 2023
Phase:
Study type: Observational

The purpose of this pilot study is to evaluate different imaging parameters in patients with previously treatment-naive DME and ME due to RVO before and after treatment with dexamethasone implant, in order to find specific retinal inflammatory and microvascular biomarkers that may be predictive of treatment outcome.

NCT ID: NCT06316388 Not yet recruiting - Clinical trials for Diabetic Macular Edema

Outcomes After Vitrectomy in Eyes With Tractional Diabetic Macular Edema

Start date: March 10, 2024
Phase:
Study type: Observational

1. assessment the outcomes of vitrectomy on retinal function by mf-ERG (multifocal electroretinogram) and anatomy by OCT (optical coherence tomography) in patients with tractional diabetic macular edema (TDME) . 2. To correlate the postoperative corrected distance visual acuity (CDVA) with the mf-ERG and OCT findings following vitrectomy surgery for TDME.

NCT ID: NCT06314217 Recruiting - Clinical trials for Diabetic Macular Edema

Everads Injector in Suprachoroidal Administration of TA Suspension, for Treatment of Patients With DME

Start date: February 18, 2024
Phase: N/A
Study type: Interventional

This is an open-label pilot device study. The aim of the study is to evaluate the safety and performance of Everads Injector following single injection of suspension approved for ocular use into the suprachoroidal space. The study population is patients diagnosed with diabetic macular edema (DME) that were previously treated. 10 adult subjects are expected to be enrolled based on the inclusion-exclusion criteria. The study will involve 6 visits during a period of 6 weeks

NCT ID: NCT06305416 Recruiting - Clinical trials for Diabetic Retinopathy

A Efficacy and Safety Study of Ranibizumab 10mg/ml Injection (Incepta) in Patients With Diabetic Macular Edema

Start date: March 20, 2024
Phase: Phase 3
Study type: Interventional

Macular edema in diabetes, defined as retinal thickening within two disc diameters of the center of the macula, results from retinal microvascular changes that compromise the blood-retinal barrier, causing leakage of plasma constituents into the surrounding retina and consequently retinal edema. Thickening of the basement membrane and reduction in the number of pericytes are believed to lead to increased permeability and incompetence of the retinal vasculature. This compromise of the blood-retinal barrier leads to the leakage of plasma constituents into the surrounding retina with subsequent retinal edema. Hypoxia produced by this mechanism can also stimulate the production of vascular endothelial growth factor (VEGF). Vascular endothelial growth factor (VEGF) increases retinal vascular permeability, causes breakdown of the blood-retina barrier and results in retinal edema. Diabetic macular edema (DME) is the most common cause of visual reduction in patients with Diabetes Mellitus. The prevalence of DME globally is around 6.8 %. Diabetic Retinopathy (DR) is the most common microvascular complication of diabetes and the leading cause of blindness worldwide. DME is a complication of diabetic retinopathy that affects the macula, which is located at the center of the retina and responsible for central vision. Bangladesh is the 10th country in the world for the number of adults living with diabetes with some 7.1 million (5.3-12.0). In Bangladesh, it is therefore expected that diabetic secondary complications, like DR, will increase along with the rising trend of diabetes mellitus. The use of therapeutic monoclonal antibodies has revolutionized in the treatment of many diseases. In recent years, millions of patients have been successfully treated with these biological agents. Ranibizumab is one such therapeutic monoclonal antibody for intraocular use. Ranibizumab is a humanized, recombinant, immunoglobulin G1 monoclonal antibody fragment against vascular endothelial growth factor A (VEGF-A) and thus prevents choroidal neovascularization. The small size of ranibizumab allows for enhanced diffusion into the retina and choroid.

NCT ID: NCT06305143 Recruiting - Clinical trials for Diabetic Macular Edema

Efficacy and Safety of Conbercept for Diabetic Macular Edema Combined With Severe Non-proliferative Diabetic Retinopathy

Start date: April 1, 2024
Phase: Phase 4
Study type: Interventional

The goal of this prospective multicenter open label study is to evaluate the efficacy and safety of intravitreal injection Conbercept (IVC) for the treatment of diabetic macular edema (DME) combined with severe nonproliferative diabetes retinopathy (sNPDR). The main questions it aims to answer are: - mean changes in best corrected visual acuity (BCVA) and central macular thickness (CMT) in comparison with baseline at 12 months after initial treatment - proportion of eyes with visual gain ≥15 letters in Early Treatment Diabetic Retinopathy Study (ETDRS) chart and ≥2-step improvement in Diabetic Retinopathy Severity Scale (DRSS) score after 12 months of the treatment - proportion of eyes actually underwent PRP treatment after 3 and 12 months of the treatment - mean changes in BCVA and CMT from baseline to monthly follow-up time point - complications and adverse effects

NCT ID: NCT06272565 Not yet recruiting - Clinical trials for Diabetic Retinopathy

Exploring the Interaction Between Metabolic Disorders and NLPR3 Inflammasome Activation in DR Inflammatory Damage

DR
Start date: March 1, 2024
Phase:
Study type: Observational

Diabetic retinopathy (DR) is one of the most serious microvascular complications of diabetes. Early diagnosis and treatment of diabetes is the key to prevent visual impairment in DR patients. This study aims to use a non-targeted metabolomics detection technique combined with ultra-high performance liquid chromatography time-of-flight mass spectrometry to analyze the metabolomics profile in aqueous humor sample of DR patents, and further explore the mechanism of the relationship between differential metabolites and their metabolic pathways with NLRP3 activation in DR inflammatory damage. DR patients with macular edema will receive anti-vascular endothelial growth factor (anti-VEGF) treatment; these patients will be divided into two groups: responders group and non-responders group.

NCT ID: NCT06262737 Recruiting - Clinical trials for Diabetic Macular Edema

Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol

PISO
Start date: September 30, 2023
Phase:
Study type: Observational

The purpose of this study is to assess the sensation of ocular dry eye symptom after an intravitreal injection of anti-VEGF.

NCT ID: NCT06237777 Recruiting - Clinical trials for Diabetic Macular Edema

A Clinical Study Evaluating the Safety, Tolerability and Initial Efficacy of SKG0106 Intravitreal Injection in Diabetic Macular Edema (DME) Patients

Start date: January 2024
Phase: Phase 1
Study type: Interventional

This is a clinical study to evaluate the safety, tolerability and initial efficacy of SKG0106 intravitreal injection in diabetic macular edema (DME) patients.

NCT ID: NCT06213896 Recruiting - Glaucoma Clinical Trials

Detecting Eye Diseases Via Hybrid Deep Learning Algorithms From Fundus Images

Start date: March 1, 2023
Phase:
Study type: Observational

Eye health is of great importance for quality of life. Some eye diseases can progress and cause permanent damage up to vision loss if they are not treated early. Therefore, it is of great importance to have regular eye examinations and to detect possible eye diseases before they progress. Healthy people should also undergo eye screening once a year, and those with any complaints regarding eye health should be examined. With the advancing technology, Artificial Intelligence (AI) has begun to play a significant role in the healthcare sector. Retinal diseases, serious health problems resulting from damage to the back part of the eye's retina, include conditions such as retinopathy, macular degeneration, and glaucoma. Artificial intelligence, with its visual recognition and analysis capabilities, holds great potential in the early diagnosis of retinal diseases. AI-based diagnosis of retinal diseases typically involves the use of specialized algorithms that analyze retinal images. These algorithms identify abnormal features in the eye, providing doctors with a quick and accurate diagnosis. EyeCheckup v2.0 will diagnose glaucoma suspicion, severe glaucoma suspicion, age-related macular degeneration diagnosis, RVO diagnosis, diabetic retinopathy diagnosis and stage, presence/absence of DME suspicion and other retinal diseases from fundus images. This study is designed to assess the safety and efficacy of EyeCheckup v2.0. The study is a single center study to determine the sensitivity and specificity of EyeCheckup to retinal and optic disc diseases. EyeCheckup v2.0 is an automated software device that is designed to analyze ocular fundus digital color photographs taken in frontline primary care settings in order to quickly screen.

NCT ID: NCT06205979 Recruiting - Clinical trials for Diabetic Macular Edema

Relationship Between Dyslipidemia and The Response of Diabetic Macular Edema to Intravitreal Injection of Anti Vascular Endothelial Growth Factor Agents

Start date: December 12, 2023
Phase: Early Phase 1
Study type: Interventional

Diabetic retinopathy (DR) is considered the main etiology of blindness among working-age adults, and Diabetic macular edema (DME) is the main reason for vision loss related to DR . Retinal oedema is responsible for retinal micro-structural alterations, retinal atrophy of photoreceptors and ganglion cell disorders . In addition, it might be considered consensual that the best improvements in VA could be accomplished when retinal oedema is managed. In the context of a chronic and progressive disease, DME has to be faced as a state to control as effectively and rapidly as possible . Vascular endothelial growth factor (VEGF) is a protein that promotes the growth of new blood vessels. It also makes the blood vessels more leaky. Anti- VEGF medicines stop the growth of these new blood vessels. This prevents damage to the retinal light receptors and loss of central vision. The DME treatment has been shifted from the laser photocoagulation to anti-VEGF therapy . The advantages of anti-VEGF therapy in decreasing DME and improving patient's vision have been reported in many studies . Ranibizumab, in addition to aflibercept, have been reported as the first line therapies among the other anti-VEGF . There are several data demonstrating the efficiency of ranibizumab in treatment of patients with DME . On the other hand, there are studies that revealed poor response of some patients to anti-VEGF therapies even after 3 or more injections Non-modifiable risk factors for diabetic retinopathy are gender and DM duration. Modifiable risk factors contributing to the development of diabetic retinopathy are elevated blood sugar levels, blood pressure, and dyslipidemia which is the imbalance of lipids such as cholesterol, low-density lipoprotein cholesterol, (LDL-C), triglycerides, and high-density lipoprotein (HDL). This condition can result from diet, tobacco exposure, or genetic . Hard exudates are thought to be induced by the leakage of lipids from dysfunctional retinal capillaries . Therefore, theses were formulated that higher levels of total cholesterol, LDL-C and triglycerides could be considered biomarkers of the development of hard exudates in DM patients . Aim of the work - Correlate between dyslipidemia and the response of patients with diabetic macular oedema to intravitreal anti-VEGF injection