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Diabetic Macular Edema clinical trials

View clinical trials related to Diabetic Macular Edema.

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NCT ID: NCT05271539 Completed - Clinical trials for Diabetic Macular Edema

Intravitreal Ranibizumab Versus Its Combination With Dexamethasone in The Treatment of Diabetic Macular Edema

Start date: July 1, 2020
Phase: Phase 3
Study type: Interventional

Intravitreal ranibizumab alone was Compared to adding dexamethasone to ranibizumab regarding central macular thickness, the visual acuity and the number of intravitreal injections needed to achieve the same effect on CMT and BCVA at the end of the 6 months duration of the study. Any significant change in final IOP, compared to baseline, in either group is reported.

NCT ID: NCT05182580 Completed - Clinical trials for Diabetic Retinopathy

Bangladesh PRODUCTIVity in Eyecare Trial

B-PRODUCTIVE
Start date: March 20, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the impact of using autonomous artificial intelligence (AI) system for identification of diabetic retinopathy (DR) and diabetic macular edema on productivity of retina specialists in Bangladesh. Globally, the number of people with diabetes mellitus is increasing. Diabetic retinopathy is a chronic, progressive complication of diabetes mellitus that affects the microvasculature of the retina, which if left untreated can potentially result in vision loss. Early detection and treatment of diabetic retinopathy can prevent potential blindness. Study Aim: To assess the impact of using autonomous artificial intelligence (AI) system for detection of diabetic retinopathy (DR) and diabetic macular edema on physician productivity in Bangladesh. Main study question: Will ophthalmologists with clinic days randomized to use autonomous AI DR detection for all persons with diabetes (diagnosed or un-diagnosed) visiting their clinic system have a greater number of examined patients with diabetes (by either AI or clinical exam), and a greater complexity of examined patients on a recognized grading scale, per physician working hour than those randomized not to have autonomous AI screening for their diabetes population? The investigators anticipate that this study will demonstrate an increase in physician productivity, supporting efficiency for both physicians and patients, while also addressing increased access for DR screening; ultimately, preventing vision loss amongst diabetic patients. The study has the potential to contribute to the evidence base on the benefits of AI for physicians and patients. Additionally, the study has the potential to demonstrate the benefits (and/or challenges) of implementing AI in resource-constrained settings, such as Bangladesh.

NCT ID: NCT05105607 Completed - Clinical trials for Diabetic Macular Edema

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of D-4517.2 After Subcutaneous Administration in Healthy Participants

Start date: January 11, 2022
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of D-4517.2 after single subcutaneous (SC) doses in healthy participants.

NCT ID: NCT05080803 Completed - Clinical trials for Diabetic Macular Edema

Diabetic Macular Edema: Relevance of Staging Progression on Therapeutic Outcome

Start date: June 1, 2021
Phase:
Study type: Observational

Retrospective multi-center observational study on functional and morphological outcome of initial therapy for DME according to ESASO Morphologic Classification.

NCT ID: NCT05019807 Completed - Clinical trials for Diabetic Macular Edema

Comparing the Compliance to Follow-up in Patients With Diabetic Macular Edema

Start date: December 18, 2020
Phase: N/A
Study type: Interventional

Diabetic retinopathy (DR) is the microvascular complication in the eye due to uncontrolled diabetes. According to the International Diabetes Federation (IDF), 382 million people had diabetes in 2013 and this number is expected to rise to 592 million by 2035, while 175 million people remain undiagnosed. Ninety percent of these people suffer from type 2 Diabetes mellitus(DM). Over time, patients with non-proliferative DR may progress to more advance stages of DR, with increased risk of vision threatening conditions such as diabetic macular edema (DME). DME is the most frequent cause of vision loss in patients with diabetes and eventually can lead to blindness. The management strategy is crucial to prevent or limit the progression of DR. Patient education creates an important tool to control diabetes, to prevent complications and to reduce the cost. Several studies point out that diabetes group education, compared with individual education, was equally effective at improving diabetes control. Another group based education for type 2 DM shown effective in improving HbA1c, knowledge of diabetes, reduction of systolic blood pressure, body weight and requirement for diabetes medication. Studies have showed that group education had significant changes compared with individual education in HbA1c in 6 and 12, months and significant changes were found in fasting blood glucose in 12 months, diabetes knowledge, and self-management skills. Moreover, a study supported that, compared with individual counselling, group self-management education was associated with fewer acute complications and some improvements in the care process. There is no adequate evidence of which educations methods are the most effective in improving clinical outcomes of people with type 2 diabetes. There was a lack in diabetes management in India regarding the multidisciplinary diabetic intervention tool. Thus the investigator's aim is to focus on interventions to improve the compliance, knowledge/awareness about diabetes, physical activity, diet plan and attendance for diabetic check-up which got emerged from a qualitative study. There is a need to monitor the diabetic patients closely to ensure the compliance towards intervention given at home.

NCT ID: NCT04795037 Completed - Clinical trials for Diabetic Macular Edema

First-In-Human Study of CU06-1004 Following Single and Multiple Ascending Doses in Healthy Volunteers

Start date: July 15, 2021
Phase: Phase 1
Study type: Interventional

This clinical trial is the first-in-human study of CU06-1004. The purpose of this phase 1 study is to assess the safety and tolerability of single and multiple ascending oral doses of CU06-1004 in healthy adult subjects.

NCT ID: NCT04782115 Completed - Clinical trials for Diabetic Macular Edema

Evaluation of RC28-E Injection in Diabetic Macular Edema

Start date: March 17, 2021
Phase: Phase 2
Study type: Interventional

This is a non-randomized, open-label, multicenter, 48-week study to investigate the efficacy, safety and pharmacokinetics of RC28-E injection in the treatment of patients with diabetic macular edema.

NCT ID: NCT04774822 Completed - Clinical trials for Diabetic Retinopathy

Validation Study of RETINA-AI Galaxy™, an Automated Diabetic Retinopathy Screening Device

Start date: March 25, 2021
Phase:
Study type: Observational

Diabetes affects approximately 35 million Americans, each of whom needs at least one retinal exam per year. However, majority 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. The standard of care in diabetes requires at least an annual eye exam to detect onset of diabetic retinopathy and to treat when indicated. This is important as diabetes is the most common cause of visual impairment and blindness in working age adults in the United States. There are too few trained professionals to diagnose diabetic retinopathy, this prompted the development of RETINA-AI Galaxy an automated software as a medical device which screens for diabetic retinopathy in the primary care setting. This observational study is designed to validate the safety and efficacy of the device.

NCT ID: NCT04772105 Completed - Clinical trials for Diabetic Macular Edema

Clinical Study of the Safety and Efficacy of BAT5906 Injection

Start date: October 16, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a multi-center, open, multiple-dose phase Ib/IIa clinical study evaluating the efficacy and safety of BAT5906 injection in patients with diabetic macular edema. BAT5906's phase I study on w-AMD shows that it is safe from 0.3-4.0 mg, and the higher dose (2.5 mg and 4 mg) may maintain the effect for longer; the same target drugs (such as brolucizumab and Abecip ) It has also been found in clinical studies that high doses can extend the dosing interval and reduce the dosing frequency. Therefore, in this study, two safe and effective doses were selected, and the optimal clinical effective dose and frequency of BAT5906 in DME were initially explored.

NCT ID: NCT04693702 Completed - Clinical trials for Diabetic Macular Edema

Observational Study of Vision Improvement in Patients With Retinal Disorders

Start date: October 1, 2021
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to assess the vision improvement achieved by patients with retinal disorders who received corneal treatments by a low vision aid device.