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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01539577
Recruitment Status : Completed
First Posted : February 27, 2012
Last Update Posted : April 20, 2016
Information provided by (Responsible Party):

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.

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
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : March 2012
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Group/Cohort Intervention/treatment
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®

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with macular oedema due to CRVO or BRVO or non-infectious uveitis

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01539577

Paris, France
Ulm, Germany
Barcelona, Spain
United Kingdom
Bradford, West Yorks, United Kingdom
Sponsors and Collaborators
Study Director: Medical Director Allergan

Responsible Party: Allergan Identifier: NCT01539577     History of Changes
Other Study ID Numbers: 206207-025
First Posted: February 27, 2012    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Macular Edema
Retinal Vein Occlusion
Uveitis, Posterior
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Uveal Diseases
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors