age-related macular degeneration MedDRA version: 20.0 Level: PT Classification code 10025409 Term: Macular degeneration System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
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:
Sponsors
Consorcio PSMAR
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: • Participate or have participated in another clinical trial with an experimental drug in the last 6 months. • Patients with other eye diseases, p. eg, advanced glaucoma or visually significant cataracts, which are likely to require surgery during the follow-up period in the eye under study. • Concomitant, ocular or systemic, administration of drugs up to 3 months before the treatment with another anti-VEGF in the contralateral eye. • High cardiovascular risk: poorly controlled arterial hypertension, history or risk of arterial thromboembolic events, history of stroke or acute myocardial infarction, anticoagulant treatment, proteinuria or major elective surgery within 3 months. • Ophthalmological risk with the intraocular injection (all intravitreal treatments): active or suspected ocular or periocular infection, severe blepharitis, history of endophthalmitis, history of retinal detachment, myopathy, glaucoma. • Hypersensitivity to the active substance or to the excipients. • Diabetic retinopathy documented. • Pregnant or nursing (lactating) women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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.;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]).;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Adverse events Withdrawal reasons;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 | — |
Countries
Spain
Contacts
Public ContactJulia Serra
IMIM
Outcome results
None listed