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Diabetic Macular Edema clinical trials

View clinical trials related to Diabetic Macular Edema.

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NCT ID: NCT05990829 Recruiting - Clinical trials for Diabetic Macular Edema

Compare the Efficacy of VItrectomy Combined With DExamethasone Implant Versus With Aflibercept in DME Patients Diagnosed by Intraoperative OCT (the VIDEO Study): Study Protocol for a Randomized Controlled Trial

Start date: October 1, 2023
Phase: Phase 4
Study type: Interventional

Diabetic macular edema (DME) is the main cause of severe vision loss in diabetic retinopathy. Intravitreal injection of anti-vascular endothelial growth factor (VEGF) and Ozurdex are two safe and effective ways to treat DME. Pars plana vitrectomy is mainly suitable for the treatment of unabsorbed vitreous hemorrhage (VH) and tractional retinal detachment caused by proliferative diabetic retinopathy (PDR). Intraoperative optical coherence tomography (OCT), a diagnostic device, can be used to evaluate the potential condition of the retina. Many patients with PDR have unclear refractive stroma due to VH and other reasons, so preoperative OCT cannot give a clear diagnosis, so the use of intraoperative OCT can judge whether the patients are complicated with DME and give corresponding treatment. The purpose of this study is to explore the prognosis of patients with DME diagnosed by OCT during PPV and treated with PPV combined with aflibercept or PPV combined with Ozurdex, and to observe and compare the postoperative anatomical results, functional results, times of reinjections and the occurrence of adverse events between the two groups, in order to provide accurate treatment for patients, reduce the frequency of postoperative vitreous injection and lighten the burden of patients.

NCT ID: NCT05978622 Recruiting - Clinical trials for Diabetic Macular Edema

Observational Study of Adult Participants With Diabetic Macular Edema and Suboptimal Response to Anti-Vascular Endothelial Growth Factor Treated With Dexamethasone Intravitreal Implant

Start date: October 30, 2023
Phase:
Study type: Observational

The dexamethasone 700 μg intravitreal implant (DEX-I) delivers dexamethasone gradually to the retina over time. It is an approved drug for the treatment of DME. This study will assess adult participants with diabetic macular edema (DME) and suboptimal response to anti-vascular endothelial growth factor therapy that are treated with DEX-I in the routine clinical setting. Approximately 327 participants who are prescribed DEX-I by their physicians will be enrolled at approximately 40 sites in approximately 10 countries globally. Participants will be followed for 18 months post-DEX-I implantation according to the routine clinical practice of the prescribing centers. Only one eye per participant will be evaluated in the study. No additional burden for participants in this trial is expected.

NCT ID: NCT05930561 Recruiting - Clinical trials for Diabetic Retinopathy

4D-150 in Patients With Diabetic Macular Edema

Start date: August 9, 2023
Phase: Phase 2
Study type: Interventional

Phase 2 randomized, active-controlled, double-masked, dose-ranging trial in adults with Diabetic Macular Edema (DME).

NCT ID: NCT05916391 Recruiting - Clinical trials for Diabetic Macular Edema

Gene Therapy for Diabetic Macular Edema

Start date: May 19, 2023
Phase: Phase 1
Study type: Interventional

FT-003 is a gene therapy product developed for the treatment of central involvement diabetic macular edema (CI-DME). Diabetic retinopathy is one of the most common microvascular complications of diabetes mellitus, and diabetic macular edema is the main cause of vision loss in patients with diabetic retinopathy. In the latest guidelines, anti-VEGF therapy is preferred for CI-DME. Administration of FT-003 has the potential to treat CI-DME by providing intraocular protein which is durable expressed in therapeutic level. FT-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with CI-DME receiving anti-VEGF therapy in clinical practice.

NCT ID: NCT05885503 Recruiting - Clinical trials for Diabetic Macular Edema

Efficacy and Safety of RC28-E Versus Aflibercept in Diabetic Macular Edema

Start date: June 8, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate efficacy and safety of RC28-E compared with Aflibercept in subjects with diabetic macular edema.

NCT ID: NCT05861466 Recruiting - Clinical trials for Diabetic Macular Edema

Comparative Study Between IVI of Ranibizumab With and Without Prior ACP in Patients With DME Using OCT-A

Start date: January 1, 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to to evaluate the changes in retinal microvasculature secondary to intra-ocular pressure changes post intra-vitreal injection in patients with diabetic macular oedema highlighting the effect of prior anterior chamber paracentesis on such changes if present . The main question[s]it aims to answer are: •[is there any effect of post intra-vitreal injection IOP spikes on retinal microvasculature?] •[is there any effect of Prior Anterior Chamber Paracentesis?] Participants in group A will be subjected to an identified approved treatment( intra-vitreal injection)& Participants in group B will be subjected to a prior ACP with the intra-vitreal injection . ]

NCT ID: NCT05752045 Recruiting - Glaucoma Clinical Trials

OphtAI Diagnostic Performance Validation for Automated Screening of Eye Diseases

OPHTAI-EVAL
Start date: June 28, 2023
Phase: N/A
Study type: Interventional

Evolucare OphtAI is a medical device offering automated, artificial intelligence powered, screening capabilities for Diabetic Retinopathy, Diabetic Macular Edema, Glaucoma, ARM and AMD, whose performances will by tested through the OphtAI-EVAL.

NCT ID: NCT05745116 Recruiting - Clinical trials for Diabetic Macular Edema

Evaluation of Repeated, In-Clinic, Self-Imaging by DME Patients Using the Notal Vision Home OCT

Start date: November 7, 2022
Phase:
Study type: Observational

Evaluation of Repeated, In-Clinic, Self-Imaging by DME Patients Using the Notal Vision Home OCT The purpose of this study is to collect data on the NVHO device at up to three sites.

NCT ID: NCT05728476 Recruiting - Clinical trials for Diabetic Macular Edema

Microinvasive Pars Plana Vitrectomy Combined ILM Peeling Versus Anti-VEGF Intravitreal Injection for Treatment-naïve Diabetic Macular Edema

Start date: March 5, 2024
Phase: N/A
Study type: Interventional

Diabetic macular edema (DME) is the main cause of vision loss in patients with diabetes. At present, anti-vascular endothelial growth factor (VEGF) intravitreal injection is the first-line therapy for DME, nevertheless, some patients do not respond well to anti-VEGF agents and often require multiple injections, which increases the psychological and economic burden of patients. Microinvasive pars plana vitrectomy (PPV) has been proven to be safe and effective for refractory DME. However, there are few studies on treatment-naïve DME. The purpose of this study is to explore whether early PPV combined with internal limiting membrane (ILM) peeling can reduce the treatment burden of DME patients, prevent vision loss, and maintain long-term stabilization of diabetic retinopathy.

NCT ID: NCT05727891 Recruiting - Clinical trials for Diabetic Macular Edema

Evaluation of Tonabersat for DME

AN
Start date: May 2, 2023
Phase: Phase 2
Study type: Interventional

This randomized clinical trial will evaluate the effect of tonabersat compared with placebo on central subfield thickness (CST) in eyes with center-involved diabetic macular edema (CI-DME) and good visual acuity.