Retrospective Data Collection Study in Patients With Macular Oedema Receiving OZURDEX®

Completed

• Conditions: Macular Edema; Retinal Vein Occlusion
• Interventions: Other: No Intervention

• Registration Number: NCT02181530
• Lead Sponsor: Allergan

Brief Summary

This study will use retrospective data to evaluate the safety and efficacy of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) in the treatment of macular oedema due to retinal vein occlusion (RVO) in clinical practice. No intervention will be administered as part of this study.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-04
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2015-04-10
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-21
• Last Update Submitted: 2015-05-21
• Results First Posted: 2015-05-25
• Last Update Posted: 2015-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Macular oedema in at least one eye due to branch retinal vein occlusion (BRVO) or central vein occlusion (CRVO)
• Received at least one injection of OZURDEX® in the study eye

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OZURDEX®	No Intervention	Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye	Baseline, 7 to 12 weeks following the first OZURDEX® injection	BCVA is measured in the study eye following each injection of OZURDEX® using a special eye chart. The number of letters read correctly Snellen fraction are converted to a decimal scale. There are 11 lines on a standard Snellen chart ranging from 0.1 (20/200) at worst to 2.0 (20/10) at best. 20/20 on the decimal scale is equal to 1.0. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision has improved.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With an Increase of 2 Lines or More in BCVA in the Study Eye	Baseline, Up to 17 Months	BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as "approxETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. An increase of 2 lines or more indicates an improvement.
Percentage of Patients With an Increase of 3 Lines or More in BCVA in the Study Eye	Baseline, Up to 17 Months	BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as "approxETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. An increase of 3 lines or more indicates an improvement.
Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)	Baseline, 7 to 12 weeks following the first OZURDEX® 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
Time to Improvement of 2 Lines or More in BCVA in the Study Eye	Baseline, Up to 17 Months	BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as "approxETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. The time in days to improvement of 2 or more lines is reported.
Time to Improvement of 3 Lines or More in BCVA in the Study Eye	Baseline, Up to 17 Months	BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as "approxETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. The time in days to improvement of 3 or more lines is reported.
Time to OZURDEX® Re-Injection in the Study Eye	Up to 17 Months