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Prospective Trial of Dexamethasone implAnt for Treatment Naïve diabeTic Macular Edema — DANTE  

Diabetic Retinopathy Clinical Trial

Official title:
Prospective Trial of Dexamethasone implAnt for Treatment Naïve diabeTic Macular Edema: The Multicenter DANTE Study

Clinical Trial Summary

The purpose of the investigator's study is to evaluate the efficacy and safety profile of the pro re nata (PRN) regimen to 12 months by using intravitreal dexamethasone implant in eyes with treatment-naive diabetic macular edema patients.

Clinical Trial Description

Pathogenesis of diabetic macular edema (DME) involves inflammation, angiogenesis, and oxidative stress processes provoked mainly by cytokines such as interleukin (IL)-6, 8, and monocyte chemotactic protein, and vascular endothelial growth factor (VEGF). Vision loss associated with diabetic retinopathy is most commonly caused by DME, which affects approximately 7% of all diabetic patients. Several therapeutic options are available for treating DME. Evidence for the use of these therapies is accumulating; however, the optical treatment choice remains unclear. In recent years, using intravitreal anti-VEGF agents to treat DME has been shown to be beneficial. Anti-VEGF injections are generally considered suitable first-line therapy for center-involved DME and are effective in improving visual acuity (VA), with 10% to 40% of patients achieving significant improvement in best-corrected visual acuity (BCVA) after 1 year of treatment.

The management of DME is complex, and often multiple treatment approaches are needed. Although anti-VEGF agents were effective for the treatment of DME, there is a proportion of patients who do not achieve optimal response to these agents, presenting refractory or persistent DME. Intravitreal administration of steroids for the treatment of DME has also been studied for many years due to their well-known, widespread, anti-inflammatory effects. Dexamethasone implant is a slow-release dexamethasone delivery system developed for intravitreal administration that has recently been introduced as a therapeutic option in DME. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04448496
Study type Interventional
Source Yeungnam University College of Medicine
Contact Min Sagong, MD,PhD
Phone 82-53-620-3443
Email msagong@ynu.ac.kr
Status Recruiting
Phase Phase 4
Start date June 22, 2020
Completion date December 31, 2021
View Details
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