NCT04005430

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

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: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Targeted Therapy Technologies, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Refractory Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Episcleral Dexamethasone	Sequestered Transscleral, Controlled-Release Dexamethasone

Timeline

• Start date: 2019-04-03
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2019-07-02
• Last updated: 2023-11-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study