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

Allergan

Status and phase: Completed; Phase 4

Conditions: Macular Edema; Retinal Vein Occlusion

Treatments: Drug: dexamethasone implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01903720

APMA-OZU-01-01

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

OZURDEX®

Experimental group

Description:

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.

Treatment:

Drug: dexamethasone implant