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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

Interventions

  • Drug: dexamethasone

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 79 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sanwa Kagaku Kenkyusho Co., Ltd.
  • Overall Official(s)
    • Clinical Study Group, Clinical Development Dept., Study Director, Sanwa Kagaku Kenkyusho Co., Ltd.

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