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
  Purpose

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.


Condition
Retinal Vein Occlusions

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Anatomic Outcomes Following Ozurdex Injection

Resource links provided by NLM:


Further study details as provided by Barnes Retina Institute:

Estimated Enrollment: 20
Study Start Date: February 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01282411

Contacts
Contact: Shantia D Shears, MA 314-367-1278 ext 2287 sshears@barnesretina.com

Locations
United States, Missouri
Barnes Retina Institute Recruiting
St. Louis, Missouri, United States, 63110
Contact: Shantia D Shears, MA    314-367-1278 ext 2287    sshears@barnesretina.com   
Principal Investigator: Gaurav K Shah, M.D.         
Sponsors and Collaborators
Barnes Retina Institute
Allergan
Investigators
Principal Investigator: Gaurav K Shah, MD Barnes Retina Institute
  More Information

No publications provided

Responsible Party: Dr. Gaurav Shah, M.D., Barnes Retina Institute
ClinicalTrials.gov Identifier: NCT01282411     History of Changes
Other Study ID Numbers: 2010.006
Study First Received: January 21, 2011
Last Updated: January 21, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014