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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