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A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion (BRAVO)

NCT00486018 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 397

Last updated 2017-05-10

Study results available
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Summary

This was a Phase III, multicenter, randomized, double-masked, sham injection-controlled study of the efficacy and safety of intravitreal ranibizumab compared with sham injections in patients with macular edema secondary to branch retinal vein occlusion (BRVO); 397 patients with BRVO were enrolled at 93 investigational sites in the United States. The study included a treatment period (6 months) and an observation period (6 months).

Conditions

  • Macular Edema
  • Retinal Vein Occlusion

Interventions

DRUG

Ranibizumab injection 0.3 mg

Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.

DRUG

Ranibizumab injection 0.5 mg

Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.

DRUG

Sham injection

Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Roman Rubio, M.D. · Genentech, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2009-05-31
Completion
2009-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00486018 on ClinicalTrials.gov