A Safety and Efficacy Study to Assess OZURDEX® in Patients With Macular Oedema Secondary to Retinal Vein Occlusion (RVO)

Completed

• Conditions: Macular Edema; Retinal Vein Occlusion
• Interventions: Drug: dexamethasone 700 ug intravitreal implant

• Registration Number: NCT01571557
• Lead Sponsor: Allergan

Brief Summary

This study will evaluate the relationship between time since onset of macular oedema symptoms and the achievement of vision gain in patients prescribed OZURDEX®. All care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and local standard of medical care.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-03
• Study First Submitted QC: 2012-04-03
• Study First Posted: 2012-04-05
• Study Start: 2012-04-30
• Primary Completion: 2014-03-31
• Study Completion: 2014-06-30
• Results First Submitted: 2015-06-22
• Results First Submitted QC: 2015-06-22
• Results First Posted: 2015-07-20
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 573

Inclusion Criteria

• Diagnosis of macular edema following retinal vein occlusion
• Prescribed OZURDEX®

Exclusion Criteria

• Previous treatment with OZURDEX®

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OZURDEX®	dexamethasone 700 ug intravitreal implant	OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye	Baseline, Week 12	BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. 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 change from baseline in the number of letters read means vision has improved and a negative number change from baseline means vision has worsened.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With an Increase of ≥2 Lines From Baseline BCVA in the Study Eye	Baseline, 48 Weeks	BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. 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). An increase of 2 letters or more indicates an improvement in BCVA.
Percentage of Patients With an Increase of ≥3 Lines From Baseline BCVA in the Study Eye	Baseline, 48 Weeks	BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. 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). An increase of 3 letters or more indicates an improvement in BCVA.
Mean Change From Baseline in Central Retinal Thickness	Baseline, Week 24	Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative mean change from baseline indicates an improvement and a positive mean change from baseline indicates a worsening.