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

Allergan289 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

289

Conditions

Retinal Vein Occlusion Macular Edema

Interventions

dexamethasone intravitreal implant 0.7 mgDRUG

Dexamethasone intravitreal implant 0.7 mg was dosed previously according to general clinical practice.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Macular edema * Received at least 2 OZURDEX® injections Exclusion Criteria: * Received OZURDEX® injections as part of a clinical study

Locations (1)

Unnamed facility

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Change From Baseline in Best Corrected Visual Acuity (BCVA) 4 to 20 Weeks Following the Last OZURDEX® (Dexamethasone Intravitreal Implant) Injection

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.

Time frame: Baseline, 4 to 20 weeks after last injection (Up to 6 months)

Secondary Outcomes

Percentage of Participants With an Increase of 2 Lines or More in BCVA

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.

Time frame: Baseline, Up to 6 months

Percentage of Participants With an Increase of 3 Lines or More in BCVA

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.

Time frame: Baseline, Up to 6 months

Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection

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.

Time frame: Baseline, 4 to 20 Weeks after Each injection (up to 6 months)

Data from ClinicalTrials.gov

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