Study of Ozurdex® Treatment Practice in Patients With Macular Oedema Due to Retinal Vein Occlusion

Completed

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

• Registration Number: NCT01618266
• Lead Sponsor: Allergan

Brief Summary

Epidemiological study of Ozurdex® in sites treating patients with retinal vein occlusion.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-06-11
• Study First Submitted QC: 2012-06-12
• Study First Posted: 2012-06-13
• Primary Completion: 2013-04
• Study Completion: 2014-10
• Results First Submitted: 2016-01-13
• Results First Submitted QC: 2016-01-13
• Status Verified: 2016-02
• Results First Posted: 2016-02-11
• Last Update Submitted: 2016-02-16
• Last Update Posted: 2016-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 375

Inclusion Criteria

• Macular oedema due to retinal vein occlusion

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Exclusion Criteria

• Not living in metropolitan France

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ozurdex® (dexamethasone intravitreal implant)	dexamethasone intravitreal implant	dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye	Baseline, Month 6	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in BCVA in the Study Eye Diagnosed With Branch Retinal Vein Occlusion (BRVO)	Baseline, Month 6	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. BRVO is a blockage of the small veins in the retina.
Change From Baseline in BCVA in the Study Eye Diagnosed With Central Retinal Vein Occlusion (CRVO)	Baseline, Month 6	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. CRVO is a blockage of the main vein in the retina.
Change From Baseline in BCVA in the Study Eye in Previously Treatment Naïve Patients	Baseline, Month 6	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Treatment naïve patients have not been previously treated for retinal vein occlusion.
Change From Baseline in BCVA in the Study Eye in Patients Previously Treated With Ozurdex®	Baseline, Month 6	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Previous treatment for retinal vein occlusion was Ozurdex®.
Change From Baseline in BCVA in the Study Eye in Patients Previously Naïve to Ozurdex® Treatment	Baseline, Month 6	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients naive to Ozurdex® have not been previously treated for retinal vein occlusion.
Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset <3 Months	Baseline, Month 6	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. The onset of macular edema was \<3 months prior to treatment.
Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset ≥3 Months	Baseline, Month 6	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. The onset of macular edema was ≥3 months prior to treatment.
Change From Baseline in BCVA in the Study Eye in Patients Only Treated With Ozurdex®	Baseline, Month 6	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients had only been previously treated with Ozurdex®.
Change From Baseline in BCVA in the Study Eye in Patients Receiving Ozurdex® and Then Other RVO Treatments	Baseline, Month 6	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients were previously treated with Ozurdex® and then switched to other RVO treatment during the study.
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye	Baseline, Month 24	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye	Baseline, Week 6, Month 4, Month 12, Month 18, Month 24	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.