Multicentre, randomised, double-blind, parallel-group, Phase III study to evaluate the genetic polymorphisms influence in the response to Ranibizumab and Bevacizumab treatment in patients with Age-Associated Macular Degeneration.

INTERVENTION: Trade Name: Avastin Product Name: AVASTIN 25 MG/ML Product Code: 650602 Pharmaceutical Form: Concentrate for solution for injection/infusion Trade Name: Lucentis Product Name: Lucentis Product Code: 106374003 Pharmaceutical Form: Solution for injection CONDITION: age‐related macular degeneration ; MedDRA version: 20.0 Level: PT Classification code 10025409 Term: Macular degeneration System Organ Class: 10015919 ‐ Eye disorders Therapeutic area: Diseases [C] ‐ Eye Diseases [C11] PRIMARY OUTCOME: Primary end point(s): ‐ Visual acuity score measured on ETDRS at 4 meters of initial distance or Snellen with conversion to ETDRS if necessary, using the method proposed by Rosenfeld et al; ; ‐ OCT criteria: presence of intraretinal and / or subretinal fluid, the presence of drusen or pigment epithelial detachment, and central macular subfield thickness (defined as the sum of the thickness of the central neurosensory retina, including eventual intraretinal fluid, and the height of the eventual subretinal fluid [central subfield macular thickness measures the thickness of a circular area of 1 mm, concentric to the foveal center]). Main Objective: 1. To evaluate the influence of the following genetic polymorphisms on a saliva sampling: VEGFA, CFH, CTFG, ARMS2, HTRA1, OR52B4, LOC387715, LOC100287225, LEPR, SERPINF1 in the response to treatment of the two drugs. Timepoint(s) of evaluation of this end point: ‐ Visual acuity score measured at baseline, 6m, 1, 2 and 3 years; ; ‐ OCT criteria at baseline and 6m and 1, 2 and 3 years Secondary Objective: 2. To evaluate the influence of the sex, age, smoking, obesity, hypertension and VA at the time of diagnosis of AMD in the response to treatment of the two drugs; 3. To evaluate the safety profile of ranibizumab and bevacizumab intravitreal injections, cardiovascular events included, after 3 injections and three years of follow‐up.; 4. To evaluate the economic impact (SNS perspective) of the use of ranibizumab and bevacizumab after one year of treatment, taking into account the drug and monitoring. SECONDARY OUTCOME: Timepoint(s) of evaluation of this end point: Adverse events at 6m, 1,2,3 years of follow‐up; Withdrawal reasons detected at 6m, 1,2,3 years of follow‐up Secondary end point(s): Adverse events; Withdrawal reasons INCLUSION CRITERIA: Patients diagnosed with neovascular Age‐related Macular Degeneration and: • Age of 50 years or older. • That at the discretion of the ophtalmologist has an indication of receiving treatment with an anti VEGF agent as usual in clinical practice. • Without previous treatment in the eye under study (no previous treatment for AMD). 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 330 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 300