Safety and Efficacy Study of Ozurdex® Compared to Lucentis® in Patients With Branch Retinal Vein Occlusion

Allergan

Status and phase: Completed; Phase 4

Conditions: Macular Edema; Retinal Vein Occlusion

Treatments: Biological: ranibizumab; Drug: dexamethasone intravitreal implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01427751

MAF-AGN-OPH-RET-004

2010-023900-29 (EudraCT Number)

Details and patient eligibility

About

This study will evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex®) compared to ranibizumab (Lucentis®) in patients with branch retinal vein occlusion (BRVO).

Enrollment: 307 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of branch retinal vein occlusion in at least one eye
• Visual acuity between 20/400 to 20/40

Exclusion criteria

• Active eye infection
• Ocular hypertension which is not controlled on monotherapy (one medication)
• Anticipated need for eye surgery during the study
• Cataract surgery in either eye within 3 months
• Eye surgery including laser of any type within 6 months
• Anti-VEGF treatment in either eye (eg, Lucentis®) within 3 months or systemic anti-VEGF treatment (eg, Avastin) within 6 months
• Use of ocular steroids within 3 months
• Use of steroids (except for inhaled or intranasal) within 1 month or anticipated use during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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307 participants in 2 patient groups

Ozurdex®

Active Comparator group

Description:

Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Patients may receive up to one additional treatment, thereafter.

Treatment:

Drug: dexamethasone intravitreal implant

Lucentis®

Active Comparator group

Description:

Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Patients will receive additional treatment thereafter based on re-treatment criteria.

Treatment:

Biological: ranibizumab