A Safety and Efficacy Study of OZURDEX® in Macular Edema Associated With Branch Retinal Vein Occlusion

Phase 4

Completed

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

• Registration Number: NCT01903720
• Lead Sponsor: Allergan

Brief Summary

This study will evaluate the safety and efficacy of OZURDEX® (700 µg dexamethasone implant) in patients with macular edema associated with branch retinal vein occlusion.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-16
• Study First Submitted: 2013-07-16
• Study First Submitted QC: 2013-07-18
• Study First Posted: 2013-07-19
• Primary Completion: 2014-09-24
• Study Completion: 2015-03-30
• Disposition First Submitted: 2015-08-31
• Disposition First Submitted QC: 2015-08-31
• Disposition First Posted: 2015-09-14
• Results First Submitted: 2016-06-10
• Results First Submitted QC: 2016-06-10
• Results First Posted: 2016-07-21
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• Diagnosis of macular edema
• Best corrected visual acuity of approximately 20/400 to 20/40 in the study eye

Exclusion Criteria

• Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month
• Intraocular surgery, including cataract surgery, and/or laser surgery of any type within 3 months
• Any active ocular infection in either eye

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OZURDEX®	dexamethasone implant	OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 6	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 (worst) to 100 letters (best). A positive number change in the number of letters read correctly means that the vision improved and a negative number change in the number of letters read correctly means that the vision has worsened.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Receiving a Third Injection	12 Months
Time to Third Injection	12 Months	Time in weeks from the second injection to the third injection.
Change From Baseline in Central Retinal Thickness (CRT) at Month 6	Baseline, Month 6	CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina. A negative change from Baseline indicates an improvement.
Change From Baseline in CRT at Month 12	Baseline, Month 12	CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina. A negative change from Baseline indicates an improvement.
Change From Baseline in CRT at Each Visit	Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12	CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina. A negative change from Baseline indicates an improvement.
Change From Baseline in BCVA at Month 12	Baseline, Month 12	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read correctly means that the vision improved and a negative number change in the number of letters read correctly means that the vision has worsened.
Change From Baseline in BCVA at Each Visit	Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). 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.
Percentage of Participants With a Change From Baseline of 15 or More Letters in BCVA	Baseline, Months 6 and 12	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). An increase in the number of letters read correctly means that the vision improved and a decrease in the number of letters read correctly means that the vision has worsened.
Percentage of Participants Receiving a Second Injection	12 Months
Time to Second Injection	12 Months	Time in weeks from the first injection to the second injection.
Percentage of Participants Who Received Laser Treatments	12 Months	Participants underwent laser photocoagulation therapy for all areas of foveal leakage and non-perfusion, as well as areas of extensive retinal hyperplasia if applicable for rescue therapy.