Skip to main content
OpenTrials
Completed

NCT Number: NCT01539577

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Retinal Vein Occlusion Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Macular Degeneration Macular Edema Panuveitis Retinal Degeneration Retinal Diseases Thrombosis Uveal Diseases Uveitis Uveitis, Posterior Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Paris, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dexamethasone 700 μg intravitreal implant

Drug

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

Other names: OZURDEX®

Primary outcomes

  1. Incidence of Patients Reporting Serious Adverse Events

    Time frame: 2 years

  2. 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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Feb 27, 2012
Registry last updated
Apr 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.