Study of Ozurdex® Treatment Practice in Patients With Macular Oedema Due to Retinal Vein Occlusion

This study has been completed.
Information provided by (Responsible Party):
Allergan Identifier:
First received: June 11, 2012
Last updated: October 30, 2014
Last verified: October 2014
Epidemiological study of Ozurdex® in sites treating patients with retinal vein occlusion.

Condition Intervention
Macular Edema
Retinal Vein Occlusion
Drug: dexamethasone intravitreal implant

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Best Corrected Visual Acuity (BCVA) [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Patients with an Improvement in BCVA [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Change from Baseline in BCVA Based on Time Since Onset of Macular Oedema [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
  • Change from Baseline in BCVA Based on Prior Treatment Received [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
  • Change from Baseline in BCVA [ Time Frame: Baseline, Month 24 ] [ Designated as safety issue: No ]
  • Percentage of Patients with an Improvement in BCVA [ Time Frame: Month 24 ] [ Designated as safety issue: No ]

Enrollment: 383
Study Start Date: November 2011
Study Completion Date: October 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ozurdex® (dexamethasone intravitreal implant)
dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment
Drug: dexamethasone intravitreal implant
dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment
Other Name: Ozurdex®


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Macular Oedema due to Retinal Vein Occlusion

Inclusion Criteria:

  • Macular oedema due to retinal vein occlusion

Exclusion Criteria:

  • Not living in metropolitan France
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01618266

Paris, France
Sponsors and Collaborators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan Identifier: NCT01618266     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/RET/009
Study First Received: June 11, 2012
Last Updated: October 30, 2014
Health Authority: France: Haute Autorité de Santé Transparency Commission

Additional relevant MeSH terms:
Macular Edema
Retinal Vein Occlusion
Cardiovascular Diseases
Embolism and Thrombosis
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Vascular Diseases
Venous Thrombosis
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on November 27, 2015