A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Ocular, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/16/2015 |
| Start Date: | November 2012 |
| End Date: | December 2014 |
There is a need to find an effective therapy for diabetic patients who develop macular edema
after cataract surgery. The objective of this study is to assess the safety and efficacy of
the OZURDEX® intraocular implant in patients with diabetes mellitus, who develop macular
edema after cataract surgery.
after cataract surgery. The objective of this study is to assess the safety and efficacy of
the OZURDEX® intraocular implant in patients with diabetes mellitus, who develop macular
edema after cataract surgery.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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