Lucentis Compared to Avastin Study. A Randomized, Double Blind, Prospective Multicenter Study Comparing the Effect of Intravitreal Injection of Bevacizumab (Avastin)to Ranibizumab (Lucentis)When Given to Patients With Exudative (Wet) Age-related Macular Degeneration
LUCAS (LUcentis Compared to Avastin Study) A randomized, double-blind, prospective
multicenter study comparing the effect of intravitreal injection of bevacizumab (Avastin) to
ranibizumab (Lucentis) when given to patients with exudative (wet) age-related macular
degeneration in Norway.
Version: 4, Protocol: 166-09, EudraCT: 2008-004225-41
LUCAS is a prospective, randomized, multicenter study comparing the effects of intravitreal
injection of bevacizumab (Avastin) with ranibizumab (Lucentis) when given to patients with
exudative (wet) AMD in Norway.
The study will include 420 patients to be recruited starting March 2009. The study will
continue for 2 years after completed enrollment.
LUCAS is a multicenter, randomized, double-blind study, with 1:1 parallel groups treated
with either bevacizumab (Avastin) 0.05 ml (25 mg/ml) or ranibizumab (Lucentis) 0,05 ml (10
mg/ml). The drug is injected intravitreally according to an "inject and extend" principle
Randomization will be stratified by center and performed with minimization according to
Bevacizumab (Avastin) will be given as an intravitreal injection of 0.05ml (25 mg/ml) from a
vial containing 4 ml.
Ranibizumab (Lucentis) will be given as an intravitreal injection of 0.05 ml (10 mg/ml) from
a vial containing 0.23 ml.
Follow-up and treatment will follow a principle called "inject and extend." This connotes
the following: initial follow-up and injection with a 4 week intervals until the macula is
dry. When dry, then follow-up and injection will be increased 2 weeks at a time. If the
patient has a recurrence of wet AMD, then the interval is reduced by 2 weeks at a time until
the macula is once again dry. The shortest interval is 4 weeks. When once again extending,
the treatment interval shall not be as long as the interval of the original recurrence, as
this could confer risk for new activity. Therefore further follow-up and injection occurs at
the "ideal" interval which is hereby defined as being 2 weeks less than that of the original
recurrence. With this method, the patient receives an injection at each follow-up, presuming
that no complications occur. The maximum interval is limited to 12 weeks. Treatment will
continue for 2 years. After the study is completed, then the patient is to be offered
continued treatment, in accordance with the ophthalmology department's routines, If there is
no response to treatment after 3 injections with a 4 week interval, then the patient shall
be removed from the study and be offered alternative treatment, such as combination
treatment with photodynamic therapy (PDT).
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Mean change in VA at 1 and 2 years as measured with the ETDRS chart
Mean change in VA at 1 and 2 years as measured with the ETDRS chart (with a non-inferiority limit of 5 letters)
After 1 and 2 years
Director of Research at Oslo University Hospital
Norway: Norwegian Medicines Agency