Anatomic Outcomes Following Ozurdex Injections

Retinal Vein Occlusions Clinical Trial

Official title:

Anatomic Outcomes Following Ozurdex Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01282411
• Other study ID #: 2010.006
• Status: Completed
• Phase: N/A
• First received: January 21, 2011
• Last updated: July 26, 2016
• Start date: February 2010
• Est. completion date: July 2011

Study information

• Verified date: July 2016
• Source: Barnes Retina Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Retinal Vein Occlusion
• Retinal Vein Occlusions

Locations

Country	Name	City	State
United States	Barnes Retina Institute	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Barnes Retina Institute	Allergan

Country where clinical trial is conducted

United States,