A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus

Completed · Phase 2

Conditions studied: Macular Edema, Diabetes Mellitus

In brief

There is a need to find an effective therapy for diabetic patients who develop macular edema after cataract surgery.

Key facts

Study ID

NCT01673191

Run by

Retinal Consultants of Arizona

People needed

40

Starts

2012-11-01

Expected to finish

2014-12-01

Last updated by the study team

2017-04-05

Who can join

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

You may qualify if…

• Patient has diagnosis of Diabetes Mellitus, Type I or II.
• Patient has experienced the development of macular edema following cataract surgery in at least one eye.
• Patient has had cataract surgery within 90 days prior to the screening visit.

You may not qualify if…

• Patient has other significant ocular disease in study eye, including glaucoma.
• Patient has any active infection in the study eye.
• Patient has uncontrolled systemic illness (i.e., uncontrolled blood pressure, uncontrolled diabetes mellitus).
• Patient has experienced a significant increase in intraocular pressure following a prior treatment with topical or intravitreal steroidal medication.
• Patient has received the OZURDEX® implant before in the study eye.

Where it is running

• Retinal Consultants of Arizona — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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