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CompletedNCT00308542Updated Feb 13, 2012

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

A Phase 1/2 interventional study of dexamethasone in Diabetic Macular Edema, sponsored by Sanwa Kagaku Kenkyusho Co., Ltd.. Completed at 12 sites in Japan. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2012-02-13.

Sponsored by Sanwa Kagaku Kenkyusho Co., Ltd. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Allocation
Non-randomized
Ages
20 Years to 79 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Diabetic Macular Edema

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Keywords

  • eye diseases
  • diabetic eye problems
03

In context

Macular Edema

841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.

Browse Macular Edema studies →

Lead sponsor

Sanwa Kagaku Kenkyusho Co., Ltd. is the lead sponsor of 19 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • History of glaucoma
  • Known steroid-responder
  • Use of systemic steroids
  • Use of Warfarin/Heparin
  • Other protocol-defined exclusion criteria may apply
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)

Interventions

  • Drugdexamethasone
06

Study locations

12 sites
  • Aichi, Japan
  • Chiba, Japan
  • Fukuoka, Japan
  • Gunma, Japan
  • Hokkaido, Japan
  • Kagawa, Japan
  • Kyoto, Japan
  • Mie, Japan
  • Miyazaki, Japan
  • Osaka, Japan
  • Shiga, Japan
  • Tokyo, Japan
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00308542
Lead sponsor
Sanwa Kagaku Kenkyusho Co., Ltd.
First posted
Mar 29, 2006
Last update
Feb 13, 2012

Study contacts

Clinical Study Group, Clinical Development Dept.
study director · Sanwa Kagaku Kenkyusho Co., Ltd.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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