A Long-Term Safety Study of OZURDEX® in Clinical Practice
|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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539577
|Bradford, West Yorks, United Kingdom|
|Study Director:||Medical Director||Allergan|