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

Retinal Consultants of Arizona1 site in 1 country40 target enrollmentNovember 2012

ConditionsMacular Edema Diabetes Mellitus

InterventionsDexamethasone intravitreal implant Steroid plus NSAID eye drop combination therapy

DrugsDexamethasone intravitreal implant Steroid plus NSAID eye drop combination therapy

Overview

Phase: Phase 2
Intervention: Dexamethasone intravitreal implant
Conditions: Macular Edema
Sponsor: Retinal Consultants of Arizona
Enrollment: 40
Locations: 1
Primary Endpoint: Mean Change in Best Corrected Visual Acuity
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

December 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Retinal Consultants of Arizona

Responsible Party

Sponsor

Eligibility Criteria

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.