Anatomic Outcomes Following Ozurdex Injections
Recruitment status was Recruiting
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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 |
| 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) |
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 |
Branch retinal vein occlusion (BRVO) Central retinal Vein occlusion (CRVO)
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| Contact: Shantia D Shears, MA | 314-367-1278 ext 2287 | sshears@barnesretina.com |
| 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. | |
| 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 May 19, 2013