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Anatomic Outcomes Following Ozurdex Injections

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Rhonda Weeks, Barnes Retina Institute
ClinicalTrials.gov Identifier:
NCT01282411
First received: January 21, 2011
Last updated: July 26, 2016
Last verified: July 2016

January 21, 2011
July 26, 2016
February 2010
May 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01282411 on ClinicalTrials.gov Archive Site
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Anatomic Outcomes Following Ozurdex Injections
Anatomic Outcomes Following Ozurdex Injection
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.
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
Branch retinal vein occlusion (BRVO) Central retinal Vein occlusion (CRVO)
Retinal Vein Occlusions
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
July 2011
May 2011   (final data collection date for primary outcome measure)

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.
Both
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01282411
2010.006
Yes
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Rhonda Weeks, Barnes Retina Institute
Barnes Retina Institute
Allergan
Principal Investigator: Gaurav K Shah, MD Barnes Retina Institute
Barnes Retina Institute
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP