A Long-Term Safety Study of OZURDEX® in Clinical Practice

Completed

• Conditions: Retinal Vein Occlusion; Macular Edema; Uveitis, Posterior
• Interventions: Drug: dexamethasone 700 μg intravitreal implant

• Registration Number: NCT01539577
• Lead Sponsor: Allergan

Brief Summary

This study is a multicenter, prospective, observational study to evaluate the long-term safety of OZURDEX® in patients with macular oedema following central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO) or patients with non-infectious posterior segment uveitis in real-world clinical practice.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-22
• Study First Submitted QC: 2012-02-22
• Study First Posted: 2012-02-27
• Study Start: 2012-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 875

Inclusion Criteria

• Macular oedema following either BRVO or CRVO or non-infectious uveitis
• Requires treatment with OZURDEX®

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Exclusion Criteria

• Current participation in any clinical study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OZURDEX®	dexamethasone 700 μg intravitreal implant	OZURDEX® (dexamethasone 700 μg intravitreal implant) administered according to general clinical practice.

Primary Outcome Measures

Name	Time	Method
Incidence of Patients Reporting Ophthalmic Adverse Events of Special Interest	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.
Incidence of Patients Reporting Serious Adverse Events	2 years