A Phase I Study of Episcleral Dexamethasone for Treatment of Macular Edema

Refractory Diabetic Macular Edema Clinical Trial

Official title: A Phase I Study of Sequestered Transscleral, Controlled-Release Dexamethasone Delivered From an Episcleral Reservoir for Treatment of Macular Edema Secondary to Diabetes and Other Causes

Status Active, not recruiting

Clinical Trial Summary

This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from refractory diabetic macular edema.

Clinical Trial Description

This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from refractory diabetic macular edema. Numerous studies have documented the anti-inflammatory activity of Dexamethasone in macular edema associated with diabetes, branch retinal vein occlusion, and non-infectious posterior uveitis. The investigators hypothesize that Episcleral Dexamethasone is safe, tolerable and that its anti-inflammatory activity will reduce macular edema and improve vision in patients with diabetic macular edema. ;

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Refractory Diabetic Macular Edema

• NCT number: NCT04005430
• Study type: Interventional
• Source: Targeted Therapy Technologies, LLC
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 3, 2019
• Completion date: September 30, 2024