Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Anatomic Outcomes Following Ozurdex Injections

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Barnes Retina Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Allergan
Information provided by:
Barnes Retina Institute
ClinicalTrials.gov Identifier:
NCT01282411
First received: January 21, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted

January 21, 2011
January 21, 2011
February 2010
December 2011   (final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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 quckly the drug works and for how long as the intial 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 structual 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 treament 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
Not Provided
Not Provided
Non-Probability Sample

Branch retinal vein occlusion (BRVO) Central retinal Vein occlusion (CRVO)

Retinal Vein Occlusions
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients younger than 21 years of age, unwilling or unable to grant infromed consent, participation in a clinical trial within the 30 days prior to enrollment. Patients receiving any other ocular therapy.
Both
21 Years and older
No
Contact: Shantia D Shears, MA 314-367-1278 ext 2287 sshears@barnesretina.com
United States
 
NCT01282411
2010.006
Yes
Dr. Gaurav Shah, M.D., Barnes Retina Institute
Barnes Retina Institute
Allergan
Principal Investigator: Gaurav K Shah, MD Barnes Retina Institute
Barnes Retina Institute
January 2011

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