Retrospective Study in Patients Receiving Two or More OZURDEX® Injections for Retinal Vein Occlusion (RVO)

Completed

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

• Registration Number: NCT01411696
• Lead Sponsor: Allergan

Brief Summary

This is a retrospective data collection study to evaluate the efficacy, safety, and re-injection interval of OZURDEX® in the treatment of macular edema due to RVO. Following informed consent, there were no patient study visits. All data was collected via chart review.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-08-05
• Study First Submitted QC: 2011-08-05
• Study First Posted: 2011-08-08
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2013-03
• Results First Submitted: 2013-03-04
• Results First Submitted QC: 2013-03-04
• Last Update Submitted: 2013-03-04
• Results First Posted: 2013-04-16
• Last Update Posted: 2013-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 289

Inclusion Criteria

• Macular edema
• Received at least 2 OZURDEX® injections

Exclusion Criteria

• Received OZURDEX® injections as part of a clinical study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Participants	dexamethasone intravitreal implant 0.7 mg	Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Best Corrected Visual Acuity (BCVA) 4 to 20 Weeks Following the Last OZURDEX® (Dexamethasone Intravitreal Implant) Injection	Baseline, 4 to 20 weeks after last injection (Up to 6 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 change in BCVA was calculated using the most improved number of lines read correctly between 4 and 20 weeks following the last injection of OZURDEX® - the number of lines read correctly at baseline. A positive change from baseline indicates improvement.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With an Increase of 2 Lines or More in BCVA	Baseline, Up to 6 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). An increase of 2 or more lines read correctly compared to baseline is an improvement.
Percentage of Participants With an Increase of 3 Lines or More in BCVA	Baseline, Up to 6 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). An increase of 3 or more lines read correctly compared to baseline is an improvement.
Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection	Baseline, 4 to 20 Weeks after Each injection (up to 6 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 after pupil dilation at baseline and 4 to 20 weeks after each injection. A negative change from baseline indicates improvement.