A Long-Term Safety Study of OZURDEX® in Clinical Practice
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|ClinicalTrials.gov Identifier: NCT01539577|
Recruitment Status : Completed
First Posted : February 27, 2012
Last Update Posted : April 20, 2016
|Condition or disease||Intervention/treatment|
|Retinal Vein Occlusion Macular Edema Uveitis, Posterior||Drug: dexamethasone 700 μg intravitreal implant|
|Study Type :||Observational|
|Actual Enrollment :||875 participants|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
OZURDEX® (dexamethasone 700 μg intravitreal implant) administered according to general clinical practice.
Drug: dexamethasone 700 μg intravitreal implant
dexamethasone 700 μg intravitreal implant administered according to general clinical practice.
Other Name: OZURDEX®
- Incidence of Patients Reporting Serious Adverse Events [ Time Frame: 2 years ]
- Incidence of Patients Reporting Ophthalmic Adverse Events of Special Interest [ Time Frame: 2 years ]The ophthalmic adverse events of special interest include: increased intraocular pressure, glaucoma, ocular hypertension, cataract formation and progression, vitreous detachment, haemorrhage, endophthalmitis (infectious/ non-infectious), retinitis secondary to reactivation of latent viral or other ophthalmic infections, retinal tear/detachment, significant vitreous leak or hypotony, systemic corticosteroid effects, and mechanical failure of device and implant misplacement.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539577
|Bradford, West Yorks, United Kingdom|
|Study Director:||Medical Director||Allergan|