Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema

Completed · Phase 2

Conditions studied: Diabetic Macular Edema, Vitrectomy

In brief

The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be followed for 26 weeks.

Key facts

Study ID

NCT00799227

Run by

Allergan

People needed

56

Starts

2009-01-01

Expected to finish

2009-12-01

Last updated by the study team

2019-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older with diabetic macular edema
• History of vitrectomy
• Central retinal thickness ≥ 275 µm
• Visual acuity between 20/320 and 20/40 in the study eye and no worse than 20/200 in the other eye

You may not qualify if…

• Known anticipated need for ocular surgery during the study period
• History of glaucoma or current high eye pressure requiring more than 1 medication
• Uncontrolled systemic disease
• Known allergy to the study medication
• Known steroid-responder
• Use of systemic steroids
• Female subjects that are pregnant, nursing or planning a pregnancy

Where it is running

• Study site — Charlotte, North Carolina, United States
• Study site — Sydney, New South Wales, Australia

Full record on ClinicalTrials.gov

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