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
50 Years
N/A
Both
Wet Age-related Macular Degeneration
Trial Information
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
Purpose:
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.
Design:
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
(5).
Randomization will be stratified by center and performed with minimization according to
prognostic factors.
Treatment Regimen:
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).
Inclusion Criteria:
1. Men and women.
2. Age ≥50 years.
3. Wet AMD in the study eye, defined as:
Not previously treated active choroidal neovascular membrane (CNV), including retinal
angiomatous proliferation (RAP), with edema involving the fovea as demonstrated with
optical coherence tomography (OCT) and fluorescein angiography (FA). FA shall not be
older than 7 days at randomization.
Best corrected visual acuity (BCVA) in the study eye 20/25 - 20/320.
4. Only one eye of each study patient may be recruited into the study. If the non-study
eye is being treated with intravitreal anti-VEGF therapy, or develops wet AMD, then
the same drug being used in the study eye shall be used in the non-study eye.
Treatment must be given double-blind in the non-study eye as well.
Exclusion Criteria:
1. Previous treatment of CNV in the study eye.
2. Participation in another AMD study, or use of other investigational medicines.
3. Anti-VEGF treatment in the non-study eye during the last 4 weeks.
4. Earlier or current treatment with systemic anti-VEGF drug.
5. Subretinal hemorrhage and/or fibrosis that involves ≥50 percent of the CNV lesion in
the study eye.
6. CNV of other pathogenesis, such as pathologic myopia (defined as having a spherical
equivalent of >8 diopters myopia) or Presumed Ocular Histoplasmosis Syndrome (POHS).
7. Presence of retinal diseases other than AMD (diabetic retinopathy, macular hole, etc)
that lead to loss of visual acuity in the study eye.
8. Cataract that will presumably require operation within 2 years or other intraocular
surgery or laser treatment during the last 3 months.
9. Impaired visualization of the retina (by vitreous hemorrhage, corneal dystrophy,
etc.) that may hamper adequate diagnosis.
10. Intraocular pressure ≥25 mm Hg, measured before mydriasis, or uncontrolled glaucoma
as evaluated by the examining ophthalmologist.
11. Active uveitis in the study eye or intraocular inflammation after use of Lucentis or
Avastin in the non-study eye.
12. Infection in one or both eyes.
13. Premenopausal women who do not use appropriate birth control, or who are nursing.
14. Patients who for mental or physical reasons are unable to comply with the study's
procedures,
15. Serious disease where there is a probability of death within the duration of the
study.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Mean change in VA at 1 and 2 years as measured with the ETDRS chart
Outcome Description:
Mean change in VA at 1 and 2 years as measured with the ETDRS chart (with a non-inferiority limit of 5 letters)
Outcome Time Frame:
After 1 and 2 years
Safety Issue:
No
Principal Investigator
Andreas Moan
Investigator Role:
Study Director
Investigator Affiliation:
Director of Research at Oslo University Hospital
Authority:
Norway: Norwegian Medicines Agency
Study ID:
1008
NCT ID:
NCT01127360
Start Date:
March 2009
Completion Date:
July 2014
Related Keywords:
- Wet Age-related Macular Degeneration
- Anti-VEGF
- Ranibizumab
- Bevacizumab
- wet AMD
- macular degeneration
- Macular Degeneration
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