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Retrospective Data Collection Study in Patients Receiving Two or More OZURDEX® Injections for Macular Oedema Secondary to Retinal Vein Occlusion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01566526
First received: March 27, 2012
Last updated: July 23, 2012
Last verified: July 2012
History of Changes
  Purpose

The purpose of this study is to use retrospective data to evaluate the efficacy, safety and re-injection interval of OZURDEX® in the treatment of macular oedema due to retinal vein occlusion (RVO) in patients who received OZURDEX® as part of the Belgium Medical Needs Program.


Condition Intervention
Retinal Vein Occlusion
Macular Oedema
 Drug: dexamethasone intravitreal implant 0.7 mg

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

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Mean Time to OZURDEX® Re-Injection [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
  • Best Corrected Visual Acuity (BCVA) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percentage of Patients with an Increase of 2 Lines or More in BCVA from Baseline [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
  • Percentage of Patients with an Increase of 3 Lines or More in BCVA from Baseline [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
  • Time to Improvement of 2 Lines or More in Best Corrected Visual Acuity (BCVA) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Time to Improvement of 3 Lines or More in Best Corrected Visual Acuity (BCVA) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: April 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Previously treated with OZURDEX®
Previously treated with OZURDEX®
 Drug: dexamethasone intravitreal implant 0.7 mg
Injection of dexamethasone intravitreal implant 0.7 mg into the study eye per standard clinical practice.
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 branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) who received OZURDEX® as part of the Belgium Medical Needs Program

Criteria

Inclusion Criteria:

  • Macular oedema in at least one eye due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
  • Received at least two OZURDEX® injections in the study eye as part of the Belgium Medical Needs Program

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566526

Locations
Belgium
Antwerpen, Belgium
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01566526     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/RET/012
Study First Received: March 27, 2012
Last Updated: July 23, 2012
Health Authority: Belgium: Institutional 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 22, 2013