Anatomic Outcomes Following Ozurdex Injections
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 7/28/2016 |
| Start Date: | February 2010 |
| End Date: | July 2011 |
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.
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.
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.
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.
We found this trial at
1
site
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