Subjects of either gender, aged> 50 years, presenting with subfoveal choroidal neovascularization due to age-related macular degeneration
Conditions
Interventions
Trade Name: Avastin
Product Name: Avastin
Pharmaceutical Form: Injection*
Trade Name: Lucentis
Product Name: Lucentis
Pharmaceutical Form: Injection*
Sponsors
Ludwig Boltzmann Institut für Retinologie und biomikroskopische Laserchirurgie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age = 50 years Active primary or recurrent subfoveal lesion with CNV secondary to AMD, activity to be proven by fluorescein angiography as described previously (Rosenfeld et al. 2006). Best corrected visual acuity assessed using ETDRS charts of 20/40 to 20/320 in the study eye. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Prior treatment with any intravitreal drug in the study eye Prior treatment with verteporfin photodynamic therapy in the study eye Prior treatment with systemic bevacizumab Prior treatment with any intravitreal durg or verteprofin photodynamic therapy in the nonstudy eye within the 3 moths before the study entry Laser photocoagulation within 1 month before study entry in the study eye Previous participation in any clinical trial within 1 month before the entry of the study Subfoveal fibrosis or atrophy in the study eye CNV in either of the two eye due to causes other than AMD such as histoplasmosis or pathologica myopia Retinal pigment epithelial tear involving the macula in the study eye Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the 12 month study period or that could contribute to a loss of best corrected visual acuity over the 12 months study period (e.g. diabetic retinopathy, cataract, uncontrolled glaucoma). The decision on exclusion is to be based on the opinion of the local principal investigator. Active intraocular inflammation Vitreous hemorrhage in the study eye History of rhematogenous retinal detachment or stage 3 or 4 macula hole in the study eye History of idiopathic or autoimmune-asscoaited uveitis in either eye Infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye Aphakia or absence of the posterior capsule in the study eye Intraocular surgery in the study eye within 2 months before the entry of the study History of corneal transplant in the study eye History of myocardial infaraction and/or stroke History of any ocular or systemic disease that according to the opinion of the local principal investiagtor may affect the interpretation of the study results or render the subject at high risk for treatment complications History of allergy to fluorescein, not amendable with diphenhydramine Inability to comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Mean change in VA over time (ETDRS charts);Secondary Objective: Kaplan-Meier proportions of the loss of 15 letters of vision (ETDRS charts)Kaplan-Meier proportions of the loss of 5 letters of vision (ETDRS charts)Proportion of patients gaining = 0, = 1, = 2 and = 3 lines in vision (ETDRS charts)Number of total injectionsLesion size, total choroidal neovascularization, leak area and area of serous sensory retinal detachment (fluorescein angiography)Retinal thickness (optical coherence tomography)Adverse events;Primary end point(s): distance visual acuity at month 12 | — |
Countries
Austria
Outcome results
None listed