A Study of the Safety and Efficacy of SK-0503 for Diabetic Macular Edema

Sanwa Kagaku Kenkyusho

Status and phase: Completed; Phase 2; Phase 1

Conditions: Diabetic Macular Edema

Treatments: Drug: dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00308542

DX4002

Details and patient eligibility

About

This study will evaluate the safety and efficacy of intravitreal implant of dexamethasone for the treatment of diabetic edema.

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diabetic macular edema
• Criteria for visual acuity and macular thickness are met

Exclusion criteria

• History of glaucoma
• Known steroid-responder
• Use of systemic steroids
• Use of Warfarin/Heparin
• Other protocol-defined exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)