BEVACIZUMAB for Neovascular age-related macular degeneration | Age-related macular degeneration

Inclusion criteria

• {"criterion_text":"- Patients diagnosed with neovascular Age-related Macular Degeneration and:  Age of 50 years or older.  That at the discretion of the ophthalmologist has an indication of receiving treatmentwith an anti VEGF agent as usual in clinical practice.  Without previous treatment in the eye under study (no previous antiVEGF treatment for AMD)."}

Exclusion criteria

• {"criterion_text":"- Participate or have participated in another clinical trial with an experimental drug in the last 6 months.\n- 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\n- Concomitant administration of antiVEGF for other non-ocular diseases\n- High cardiovascular risk within last 3 months (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) or if patient is unstable at the time of planned Intravitreal injection, except for stable patients with favorable consultation with additional relevant physicians prior to the administration (p.e. cardiologist)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\n- Hypersensitivity to the active substance or to the excipients\n- Diabetic retinopathy documented\n- Pregnant or nursing (lactating) women."}

Primary endpoints

• {"endpoint_text":"- 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, between the baseline and final evaluations. Main outcome will be assessed at 1 year.Genetic polymorphism: Saliva samples will be collected using oral swabs suitable for obtaining DNA. The genomic DNA will be obtained from a first digestion of the sample wit","definition_or_measurement_approach":"Visual acuity measured on ETDRS at 4 meters or Snellen converted to ETDRS using Rosenfeld et al method, comparing baseline and final evaluations; main outcome assessed at 1 year. Genetic polymorphism assessment by saliva samples collected with oral swabs and genomic DNA extraction (text truncated in source)."}

Spain

Earliest CTIS Part Ii Submission Date

21-10-2024

Latest Decision Or Authorization Date

26-06-2025

Processing Time Days

248

Number Of Sites

5

Number Of Participants

574

Primary sponsor

Full Name

Consorci Mar Parc De Salut De Barcelona

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain