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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: March 27, 2013
Last verified: March 2013
  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:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Time to OZURDEX® Re-Injection in the Study Eye [ Time Frame: Up to 12 Months ] [ Designated as safety issue: No ]
    The time interval is measured from the first OZURDEX® injection to the second OZURDEX® injection in the study eye.


Secondary Outcome Measures:
  • Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following Last Injection in the Study Eye [ Time Frame: Baseline, 7 to 12 weeks following the last injection ] [ Designated as safety issue: No ]
    BCVA is measured in the study eye following each injection of OZURDEX® using a special eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision has improved. Data are reported for the 7-12 week period following the last injection.

  • Percentage of Patients With an Increase of 2 Lines or More in BCVA From Baseline in the Study Eye [ Time Frame: Baseline, Up to 12 Months ] [ Designated as safety issue: No ]
    BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 2 lines or more indicates an improvement.

  • Percentage of Patients With an Increase of 3 Lines or More in BCVA From Baseline in the Study Eye [ Time Frame: Baseline, Up to 12 Months ] [ Designated as safety issue: No ]
    BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 3 lines or more indicates an improvement.

  • Change From Baseline in Central Retinal Thickness in the Study Eye by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following Last Injection [ Time Frame: Baseline, 7 to 12 weeks following the last injection ] [ Designated as safety issue: No ]
    OCT is measured in the study eye following each injection of OZURDEX®. OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicates an improvement. Data are reported for the 7-12 week period following the last injection.

  • Time to Improvement of 2 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye [ Time Frame: Baseline, Up to 12 Months ] [ Designated as safety issue: No ]
    BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 2 lines or more indicates an improvement.

  • Time to Improvement of 3 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye [ Time Frame: Baseline, Up to 12 Months ] [ Designated as safety issue: No ]
    BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 3 lines or more indicates an improvement.


Enrollment: 26
Study Start Date: March 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients Previously Treated with OZURDEX®
OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
Drug: dexamethasone intravitreal implant 0.7 mg
OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
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
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: 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
Results First Received: March 27, 2013
Last Updated: March 27, 2013
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Vein Occlusion
Cardiovascular Diseases
Embolism and Thrombosis
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Signs and Symptoms
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

ClinicalTrials.gov processed this record on November 20, 2014