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

This study is currently recruiting participants.
Verified June 2012 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01618266
First received: June 11, 2012
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

Epidemiological study of Ozurdex® in sites treating patients with retinal vein occlusion.


Condition Intervention
Macular Edema
Retinal Vein Occlusion
 Drug: dexamethasone intravitreal implant (Ozurdex®)

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

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

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 ]

Estimated Enrollment: 300
Study Start Date: November 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: March 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 (Ozurdex®)
dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment
Other Name: Ozurdex®

  Eligibility

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

Criteria

Inclusion Criteria:

  • Macular oedema due to retinal vein occlusion

Exclusion Criteria:

  • Not living in metropolitan France
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01618266

Contacts
Contact: Allergan Inc. clinicaltrials@allergan.com

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

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01618266     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/RET/009
Study First Received: June 11, 2012
Last Updated: June 12, 2012
Health Authority: France: Haute Autorité de Santé Transparency Commission

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dexamethasone acetate
Dexamethasone
 Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on October 17, 2012