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

March 27, 2012
March 27, 2013
March 2012
June 2012   (final data collection date for primary outcome measure)
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.
Mean Time to OZURDEX® Re-Injection [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01566526 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 ]
Not Provided
Not Provided
 
Retrospective Data Collection Study in Patients Receiving Two or More OZURDEX® Injections for Macular Oedema Secondary to Retinal Vein Occlusion
Not Provided

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Patients with branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) who received OZURDEX® as part of the Belgium Medical Needs Program.

  • Retinal Vein Occlusion
  • Macular Oedema
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®
Patients Previously Treated with OZURDEX®
OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
Intervention: Drug: dexamethasone intravitreal implant 0.7 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01566526
MAF/AGN/OPH/RET/012
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP