Clinical Trials Logo
  1. Home
  2. Diabetic Macular Edema
  3. NCT00308542
  4. Details
NCT00308542 Clinical Trial

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

Diabetic Macular Edema Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00308542
Other study ID # DX4002
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received March 27, 2006
Last updated February 9, 2012

Study information
Verified date February 2012
Source Sanwa Kagaku Kenkyusho Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 79 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• dexamethasone

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sanwa Kagaku Kenkyusho Co., Ltd.

Country where clinical trial is conducted

Japan, 

See also
  Status Clinical Trial Phase
Completed NCT03953807 - A Study to Evaluate the Effectiveness and Safety of OZURDEX® in Patients With Diabetic Macular Edema But Never Treated Phase 4
Completed NCT03622580 - A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE) Phase 3
Recruiting NCT06262737 - Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol
Terminated NCT04611152 - A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) Phase 3
Terminated NCT04603937 - A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) Phase 3
Active, not recruiting NCT04108156 - This Study Will Evaluate the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Participants With Diabetic Macular Edema Compared With Intravitreal Ranibizumab Phase 3
Completed NCT02867735 - A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema Phase 1
Withdrawn NCT03629210 - Combination OZURDEX® & EyLea® vs. OZURDEX® Monotherapy in IncompLete-Responders wIth Diabetic Macular Edema Phase 2
Withdrawn NCT02842541 - Safety Study of Intravitreal EBI-031 Given as a Single or Repeat Injection to Subjects With Diabetic Macular Edema Phase 1
Completed NCT02221453 - Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide Phase 2
Completed NCT02556723 - Intravitreal Injections of Ziv-aflibercept for Macular Diseases N/A
Completed NCT02979665 - Changes to the Retina Following Anti-VEGF Treatments for Diabetic Macular Edema
Completed NCT02000102 - Outcomes of Diabetic Macula Edema Patients Switched to Aflibercept From Bevacizumab and/or Ranibizumab N/A
Completed NCT02088229 - Relating Retinal Structural and Functional Parameters to Visual Acuity in Eyes Undergoing Treatment for Diabetic Macular Edema N/A
Terminated NCT00779142 - Utility of Intravitreal Methotrexate in Diabetic Macular Edema Resistant to Conventional Therapies N/A
Completed NCT01171976 - Efficacy and Safety of Ranibizumab in Two "Treat and Extend" Treatment Algorithms Versus Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus Phase 3
Completed NCT00989989 - Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema Phase 3
Terminated NCT00768040 - Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema Phase 2
Completed NCT00683176 - Effect of Choline Fenofibrate (SLV348) on Macular Edema Phase 2
Completed NCT01259609 - Changes in Ciliary Body Thickness in Patients With Diabetic Macular Edema After Vitrectomy N/A