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

April 9, 2019 updated by: Allergan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

573

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with macular oedema due to retinal vein occlusion

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous treatment with OZURDEX®

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OZURDEX®
OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
Drug: dexamethasone 700 ug intravitreal implant
dexamethasone 700 ug intravitreal implant administered according to standard of care.
Other Names:
  • OZURDEX®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Time Frame: 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.
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With an Increase of ≥2 Lines From Baseline BCVA in the Study Eye
Time Frame: 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.
Baseline, 48 Weeks
Percentage of Patients With an Increase of ≥3 Lines From Baseline BCVA in the Study Eye
Time Frame: 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.
Baseline, 48 Weeks
Mean Change From Baseline in Central Retinal Thickness
Time Frame: 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.
Baseline, Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2012

Primary Completion (Actual)

March 31, 2014

Study Completion (Actual)

June 30, 2014

Study Registration Dates

First Submitted

April 3, 2012

First Submitted That Met QC Criteria

April 3, 2012

First Posted (Estimate)

April 5, 2012

Study Record Updates

Last Update Posted (Actual)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 9, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAF/AGN/OPH/RET/011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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