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OpenTrials
Completed

NCT Number: NCT01805323

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

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.

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Key information

Conditions

Macular Edema Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Québec, Quebec, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

dexamethasone Intravitreal Implant

Drug

Dexamethasone Intravitreal Implant (OZURDEX®) previously administered according to general clinical practice.

Other names: OZURDEX®

Primary outcomes

  1. Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)

    Time frame: 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 outcomes

  1. Peak Mean Change From Baseline in Central Retinal Thickness (CRT)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 6, 2013
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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