NCT01903720 - A Safety and Efficacy Study of OZURDEX® in Macular Edema Associated With Branch Retinal Vein Occlusion | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Enrollment

71

Conditions

Macular Edema Retinal Vein Occlusion

Interventions

dexamethasone implantDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Seoul, South Korea

Outcomes

Primary Outcomes

Change From Baseline in Best Corrected Visual Acuity (BCVA) at 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.

Time frame: Baseline, Month 6

Secondary Outcomes

Change From Baseline in Central Retinal Thickness (CRT) at 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.

Time frame: Baseline, Month 6

Change From Baseline in BCVA at 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.

Time frame: Baseline, Month 12

Change From Baseline in CRT at 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.

Time frame: Baseline, Month 12

Change From Baseline in BCVA at Each Visit

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.