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

Completed

• Conditions: Retinal Vein Occlusion; Macular Oedema
• Interventions: Drug: dexamethasone intravitreal implant 0.7 mg

• Registration Number: NCT01566526
• Lead Sponsor: Allergan

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 available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-27
• Study First Submitted QC: 2012-03-28
• Study First Posted: 2012-03-29
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-03
• Results First Submitted: 2013-03-27
• Results First Submitted QC: 2013-03-27
• Last Update Submitted: 2013-03-27
• Results First Posted: 2013-05-27
• Last Update Posted: 2013-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients Previously Treated with OZURDEX®	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.

Primary Outcome Measures

Name	Time	Method
Time to OZURDEX® Re-Injection in the Study Eye	Up to 12 Months	The time interval is measured from the first OZURDEX® injection to the second OZURDEX® injection in the study eye.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following Last Injection in the Study Eye	Baseline, 7 to 12 weeks following the last injection	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	Baseline, Up to 12 Months	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	Baseline, Up to 12 Months	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	Baseline, 7 to 12 weeks following the last injection	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	Baseline, Up to 12 Months	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	Baseline, Up to 12 Months	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.