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

Allergan875 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

875

Conditions

Retinal Vein Occlusion Macular Edema Uveitis, Posterior

Interventions

dexamethasone 700 μg intravitreal implantDRUG

dexamethasone 700 μg intravitreal implant administered according to general clinical practice.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Macular oedema following either BRVO or CRVO or non-infectious uveitis * Requires treatment with OZURDEX® Exclusion Criteria: * Current participation in any clinical study

Locations (4)

Unnamed facility

Paris, France

Unnamed facility

Ulm, Germany

Unnamed facility

Barcelona, Spain

Unnamed facility

Bradford, West Yorks, United Kingdom

Outcomes

Primary Outcomes

Incidence of Patients Reporting Serious Adverse Events

Time frame: 2 years

Incidence of Patients Reporting Ophthalmic Adverse Events of Special Interest

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.

Time frame: 2 years

Data from ClinicalTrials.gov

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