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

Sponsor
Allergan
Study ID
NCT01427751
Phase
PHASE4
Status
Completed

Conditions

  • Macular Edema
  • Retinal Vein Occlusion

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • dexamethasone intravitreal implant — DRUG
    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.
  • ranibizumab — BIOLOGICAL
    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.

Study Details

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).

Key Dates

First listed
Sep 2, 2011
Start date
Oct 11, 2011
Status verified
Apr 2019
Primary completion
Nov 4, 2014
Completion
Nov 4, 2014

Study Design

Enrollment
307 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Ozurdex®
    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.
  • Active Comparator: Lucentis®
    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.

Primary Outcome Measure

Change From Baseline in Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline, Month 12 ]

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