A Randomized Study Comparing Ranibizumab to Sham in Patients With Macular Edema Secondary to CRVO
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized Study Comparing the Safty Anf Efficacy of Ranibizumab (Lucentis®) to Sham in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO|
- The primary efficacy outcome measure is the mean change from baseline in BCVA score [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Mean change from baseline in BCVA score, central foveal thickness and in the NEI VFQ-25 near activities subscale. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2007|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Active Comparator: A
0.5 ml 10mg/ml (0.5 mg) ranibizumab for intravitreal injection
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.
|Sham Comparator: B||
Sham injection with an empty, sterile 3-ml stopped glass vial. # monthly sham-injections, followed by reinjection for 3 months if present edema.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567697
|Bettina Kinge, Retinaklinikken Aleris|
|Oslo, Norway, 0264|
|Ingar Stene Johansen|
|Principal Investigator:||Bettina Kinge, MD DMSc||Aleris Helse, Oslo|