RABIMOEfficacy of Ranibizumab Treatment Every 2 Month Compared to Treatment on Demand on Patients With Choroidal Neo-vascularization (CNV) as a Consequence of Age-related Macular Degeneration (AMD)

Date de début de l'étude : 1 avril 2010

Inclusion Criteria: patients with choroidal neo-vascularization (CNV) as a consequence of age-related macular degeneration (AMD) age 50 and older, male and female membrane <= 12 papillary diameter visual acuity between 20/320 and 20/40 (ETDRS) written informed consent Exclusion Criteria: known hypersensitivity to the medicinal product under investigation, ingredients or medicinal products with a similar chemical structure participation in another clinical trial within the last 4 weeks unability to understand trial information pregnant or lactating women women with an amenorrhea < 12 months suspected unability to cooperate detachment of pigment epithelium without membrane detection >= 50%,retinal angiomatotic proliferation (RAP), presumed ocular histoplasmosis syndrome (POHS), chorioretinal anastomosis (CRA), myopic CNV, CNV following trauma, uveitis, RCS or reasons except AMD rupture of pigment epithelium sub-retinal bleeding >= 50% of membrane or >= 1 PD sub-retinal fibrosis or chorio-atrophy pre-treatment with Verteporfin (photodynamic therapy), radiotherapy, trans-pupillary thermotherapy of the eye under investigation as a consequence of maculadegeneration treatment with Verteporfin of the eye not under investigation within 7 days prior inclusion former participation in clinical trials with anti-angiogenic substances: Pegaptanib, Ranibizumab, Bevacizumab, Anecortave Acetat, Proteinkinase C Inhibitors former injection of anti-angiogenic substances in the eye under investigation former focal sub-foveal lasercoagulation of the eye under investigation juxta- or extra-foveal lasercoagulation of the eye under investigation within 1 month prior inclusion former vitrectomy former surgery as a consequence of maculadegeneration glaucoma patients which have been treated with prostaglandin containing eye drops other ocular diseases which may lead to surgery within the clinical study or may lead to a loss of vision of two lines acute intraocular inflammation of the eye under investigation vitreous hemorrhage of the eye under investigation macula-foramen of the eye under investigation diabetic retinopathy former retina detachment of the eye under investigation uveitis acute conjunctivitis, keratitis, scleritis, or endophthalmitis aphakia or pseudo-aphakia with damaged back-capsule(exception: YAG-capsulotomy) myopia larger than -8 diopter former intra-ocular surgery of the eye under investigation within 2 months prior inclusion de-compensated glaucoma with >= 30 mm Hg despite therapy former filtrating glaucoma surgery of the eye under investigation former corneal grafting of the eye under investigation former stroke or heart attack on-going therapy because of systemic infection known allergic reaction to fluorescein bad quality of fundus documentation because of bad range of vision