A Randomized Study Comparing Ranibizumab to Sham in Patients With Macular Edema Secondary to CRVO

Sponsor
Aleris Helse
Study ID
NCT00567697
Phase
PHASE3
Status
Completed

Conditions

  • Central Retinal Vein Occlusion
  • Macular Edema

Eligibility Criteria

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

Interventions

  • ranibizumab — DRUG
    0.5 ml 10mg/ml (0.5 mg) ranibizumab for intravitreal injection. Monthly injection for 3 months, followed by reinjection if edema for a total of 6 months.
  • ranibizumab — DRUG
    Sham injection with an empty, sterile 3-ml stopped glass vial. # monthly sham-injections, followed by reinjection for 3 months if present edema.

Study Details

A prospective multicenter study comparing patients with CRVO amd secondary macular edema treated with ranibizumab versus sham. Safety and efficacy will be evaluated. Patients will be randomized in a 1:1 ratio to one of the two arms. 32 patients, 6 months follow up. There will be monthly visits with injection the first three months and subsequently new injection if present edema.

Key Dates

First listed
Dec 5, 2007
Start date
Mar 31, 2007
Status verified
Jan 2012
Primary completion
Oct 31, 2008
Completion
Oct 31, 2008

Study Design

Enrollment
32 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: A
    0.5 ml 10mg/ml (0.5 mg) ranibizumab for intravitreal injection
  • Sham Comparator: B

Primary Outcome Measure

The primary efficacy outcome measure is the mean change from baseline in BCVA score [ Time Frame: 6 months ]

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