Efficacy and Safety of Ranibizumab in Japanese Patients With Retinal Vein Occlusion

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01377597
Phase
PHASE3
Status
Completed

Conditions

  • Retinal Vein Occlusion

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to provide efficacy and safety data of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab in Japanese patients with visual impairment due to macular edema secondary to retinal vein occlusion (BRVO or CRVO) to support the applicability of the phase III study results of BRAVO and CRUISE in this indication, in the Japanese ethnic patients.

Key Dates

First listed
Jun 21, 2011
Start date
Jun 30, 2011
Status verified
Nov 2016
Primary completion
Apr 30, 2012
Completion
Apr 30, 2012

Study Design

Enrollment
47 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ranibizumab intravitreal injection

Primary Outcome Measure

Measure: Efficacy of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab as assessed by the mean average change in best-corrected visual acuity (BCVA) from Month 1 through Month 3 compared to baseline [ Time Frame: 3 months ]

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