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Post Market Surveillance of OZURDEX® for Branch Retinal Vein Occlusion (BRVO) and Central Retinal Vein Occlusion (CRVO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01568021
First received: March 29, 2012
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

This multicenter observational study will assess the efficacy and tolerability of OZURDEX® in clinical practice, and will assess the time at which patients are considered for retreatment.


Condition Intervention
Retinal Vein Occlusion
Macular Edema
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:
  • Change from Baseline in Visual Acuity (VA) Score [ Time Frame: Baseline, 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • VA Score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Patient Assessment of Treatment Acceptability Using a Questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Physician Assessment of Treatment Acceptability Using a Questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Amount of Time Between Retreatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Physician Reasons for Retreatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: October 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
OZURDEX®
Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year.
Drug: Dexamethasone intravitreal implant
Single dose of dexamethasone 700 ug intravitreal implant which may be repeated over 1 year.
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 BRVO and CRVO prescribed OZURDEX®

Criteria

Inclusion Criteria:

  • Macular Edema
  • Prescribed OZURDEX®

Exclusion Criteria:

  • None
  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 ClinicalTrials.gov identifier: NCT01568021

Locations
Denmark
Glostrup, Denmark
Norway
Oslo, Norway
Sweden
Uppsala, Sweden
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01568021     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/RET/007
Study First Received: March 29, 2012
Last Updated: January 23, 2014
Health Authority: Sweden: Regional Ethical Review Board

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

ClinicalTrials.gov processed this record on November 27, 2014