A Retrospective Chart Review of OZURDEX® in Patients With Macular Edema

Completed

• Conditions: Macular Edema
• Interventions: Drug: Dexamethasone Intravitreal Implant

• Registration Number: NCT01805323
• Lead Sponsor: Allergan

Brief Summary

This retrospective chart review study will describe the history of patients with retinal disease with macular edema to whom OZURDEX® (dexamethasone intravitreal implant) is administered, and assess treatment patterns and visual outcomes. OZURDEX® was previously administered according to general clinical practice.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-01
• Study First Submitted: 2013-03-05
• Study First Submitted QC: 2013-03-05
• Study First Posted: 2013-03-06
• Primary Completion: 2013-04-15
• Study Completion: 2013-04-15
• Results First Submitted: 2014-04-28
• Results First Submitted QC: 2014-04-28
• Results First Posted: 2014-05-30
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Retinal disease involving macular edema
• Received at least one OZURDEX® injection

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Participants	Dexamethasone Intravitreal Implant	Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.

Primary Outcome Measures

Name	Time	Method
Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)	Baseline, 2 to 26 weeks (wks) following last injection (up to 6.5 months)	BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). The peak mean change in BCVA was calculated using the most improved number of lines read correctly between 2 and 26 weeks following the last available injection of OZURDEX® - the number of lines read correctly at Baseline. A positive change from Baseline indicated improvement.

Secondary Outcome Measures

Name	Time	Method
Peak Mean Change From Baseline in Central Retinal Thickness (CRT)	Baseline, 2 to 26 weeks following last injection (up to 6.5 months)	Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye. The peak mean change was the maximum change from Baseline in CRT at 2 to 26 weeks following the last available injection of OZURDEX®. A negative change from Baseline indicated improvement.