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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 27, 2012

Last Updated Date

March 27, 2013

Start Date ^ICMJE

March 2012

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT01566526 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition ^ICMJE

Retinal Vein Occlusion
Macular Oedema

Intervention ^ICMJE

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®

Study Group/Cohort (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2012

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT01566526

Other Study ID Numbers ^ICMJE

MAF/AGN/OPH/RET/012

Has Data Monitoring Committee

Responsible Party

Allergan

Study Sponsor ^ICMJE

Allergan

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Director

Allergan

Information Provided By

Allergan

Verification Date

March 2013

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

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