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

Sponsor
Genentech, Inc.
Study ID
NCT00485836
Phase
PHASE3
Status
Completed

Conditions

  • Macular Edema
  • Retinal Vein Occlusion

Eligibility Criteria

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

Interventions

  • Sham injection — DRUG
    Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
  • Ranibizumab injection 0.3 mg — DRUG
    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.
  • Ranibizumab injection 0.5 mg — DRUG
    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.

Study Details

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 central retinal vein occlusion (CRVO); 392 patients with CRVO were enrolled at 95 investigational sites in the United States. The study included a treatment period (6 months) and an observation period (6 months).

Key Dates

First listed
Jun 13, 2007
Start date
Jul 31, 2007
Status verified
Jun 2017
Primary completion
Jun 30, 2009
Completion
Dec 31, 2009

Study Design

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

Arms

  • Sham Comparator: Sham injection
  • Experimental: Ranibizumab injection 0.3 mg
  • Experimental: Ranibizumab injection 0.5 mg

Primary Outcome Measure

Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months [ Time Frame: Baseline and 6 months ]

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