LUCAS (Lucentis Compared to Avastin Study)

Sponsor
Oslo University Hospital
Study ID
NCT01127360
Phase
PHASE4
Status
Completed

Conditions

  • Exudative Age-related Macular Degeneration

Eligibility Criteria

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

Interventions

Study Details

Age-related macular degeneration (AMD) is the most common cause of blindness in individuals over 50 years of age. Bevacizumab and ranibizumab are two agents developed by the American pharmaceutical corporation Genentech, both of which inhibit blood vessel growth factors. These drugs, when injected intraocularly, reduce the pathological growth of blood vessels in the macular area of the eye. Bevacizumab (Avastin) is an antibody developed for intravenous treatment of metastasized colon cancer. Ranibizumab (Lucentis) is an antibody fragment developed from a similar antibody. It was introduced 2006 as an effective treatment for wet AMD. Treatment costs are, however, up to 50 times higher compared to use of bevacizumab. Avastin has shown similar effects to ranibizumab, and has been used off-label in many countries, both before and after Lucentis received approval. There is thus a recognized need for large randomized studies to garner proper scientific proof of Avastin's effectiveness regarding exudative AMD. LUCAS is a randomized multicenter study, performed in Norway, comparing ranibizumab and bevacizumab use for AMD. The goal of the study was to demonstrate if the two agents were equivalent regarding both efficacy and safety. A total of 441 patients with objective evidence of wet AMD were randomized to a double-blind treatment with ranibizumab or bevacizumab over the course of 2 years. The treatment interval was determined by a "Treat and Extend" protocol.

Key Dates

First listed
May 20, 2010
Start date
Mar 31, 2009
Status verified
Jan 2015
Primary completion
Aug 31, 2014
Completion
Aug 31, 2014

Study Design

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

Arms

  • Experimental: Bevacizumab
    Bevacizumab 1,25 mg, intravitreal injections every 4th to 12th week
  • Active Comparator: Ranibizumab
    Ranibizumab 0,5 mg, intravitreal injection, every 4th to 12th week

Primary Outcome Measure

Mean change in VA at 1 and 2 years as measured with the ETDRS chart [ Time Frame: After 1 and 2 years ]