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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01568021
First received: March 29, 2012
Last updated: April 2, 2013
Last verified: April 2013
History of Changes
  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:

MedlinePlus related topics: Edema
U.S. FDA Resources

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
Estimated Study Completion Date: December 2013
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01568021

Locations
Denmark
Copenhagen, 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: April 2, 2013
Health Authority: Sweden: Regional Ethical Review Board

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 May 16, 2013