Anatomic Outcomes Following Ozurdex Injection

Barnes Retina Institute1 site in 1 country10 target enrollmentFebruary 2010

ConditionsRetinal Vein Occlusions

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Retinal Vein Occlusions
Sponsor: Barnes Retina Institute
Enrollment: 10
Locations: 1
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Ozurdex(TM) has recently been FDA approved for use in macular edema secondary to retinal vein occlusion. It remains unclear how quickly the drug works and for how long as the initial studies did not have frequent anatomic monitoring. This study will utilize frequent Spectral domain OCT imaging to better understand the onset of treatment effectiveness and duration of action on the anatomic thickness of the retina, in addition to distinguishing structural abnormalities of responders from non-responders.

Detailed Description

Focal laser therapy has been the gold standard for the treatment of macular edema secondary to branch vein occlusion (BRVO), though it has not been shown to be effective for central vein occlusion (CRVO). Intravitreal corticosteroids have been shown in many case series to be effective at diminishing macular edema secondary to both BRVO and CRVO. Sustained drug delivery models have been sought after to relieve the need for frequent injections. Ozurdex has recently been found to be effective for the treatment of macular edema following BRVO or CRVO and has been approved by the FDA for these indications. The onset of effectiveness and duration of action on the anatomic thickness of the retina have not yet been demonstrated. In addition, it is uncertain as to when the clinician can label the patient as a responder or nonresponder. We also believe this study will help identify patients that may need more frequent dosing schedules.

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

July 2011

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Barnes Retina Institute

Responsible Party

Principal Investigator

Rhonda Weeks

Gaurav K. Shah, MD

Barnes Retina Institute

Eligibility Criteria

Inclusion Criteria

•Patients diagnosed with BRVO/CRVO who are otherwise eligible to receive treatment with Ozurdex (TM)

Exclusion Criteria

•Patients younger than 21 years of age, unwilling or unable to grant informed consent, participation in a clinical trial within the 30 days prior to enrollment. Patients receiving any other ocular therapy.