Safety and Efficacy of Switching From Aflibercept to Ranibizumab in Patients With nAMD (SAFARI)

This is an interventional treatment trial for Neovascular Age-related Macular Degeneration focused on measuring Macular degeneration, age-related macular degeneration (ARMD), vision loss, macula damage, retina damage, dry macular degeneration, wet macular degeneration, AMD Read More

Inclusion Criteria:

• Best corrected visual acuity (BCVA) ≥23 ETDRS letters in study eye
• Evidence of active choroidal neovascularisation (CNV) involving the center of the fovea in study eye Patient subgroup specific inclusion criteria: - Group 1. Primary treatment failure
• Initiated treatment with aflibercept <130 days prior to the Screening Visit.
• No increase in BCVA (≥5 letters) since commencing treatment with aflibercept.
• Disease activity has never been controlled in the study eye after initiating aflibercept as defined by at least one of the following: evidence of unchanged or increasing retinal or subretinal fluid; new PED; unchanged or increasing size of preexisting PED.

Group 2. Suboptimal treatment response

• Aflibercept commenced ≥6 months prior to the Screening Visit.
• Received ≥3 aflibercept injections into the study eye within 6 months of the Screening Visit.
• Evidence of previous reduced disease activity (as defined by reduction of ≥50μm in Central Subfield Retinal Thickness on OCT) noted in the study eye after initiating aflibercept.
• At Screening Visit, disease activity has worsened (as defined by increasing retinal* or subretinal fluid, or new or increasing size of PED) in the study eye compared to prior visits.

Exclusion Criteria:

• History of cerebrovascular accident, transient ischemic attack or myocardial infarction within 3 months of the Screening visit.
• Uncontrolled blood pressure
• Evidence of bilateral active CNV during the Screening Period or at Baseline requiring bilateral antiVEGF injections.
• Prior intravitreal injection of ranibizumab or bevacizumab into the study eye and/or prior intravitreal injection of bevacizumab into the fellow eye.
• Cataract (if causing significant visual impairment), aphakia, severe vitreous hemorrhage, rhegmatogenous retinal detachment, proliferative retinopathy or choroidal neovascularization of any other cause than wet AMD (e.g. ocular histoplasmosis, pathologic myopia (≥8 dioptres)) at the time of Screening and Baseline.
• Irreversible structural damage involving the center of the fovea (e.g. advanced fibrosis or geographic atrophy) which in the opinion of the Investigator is sufficient to irreversibly impair visual acuity.
• Polypoidal choroidal vasculopathy (PCV), RPE tear, central serous retinopathy (CSR), or significant vitreomacular traction identified during Screening period or within 4 months of Baseline visit.
• Unable to obtain at Screening OCT images of sufficient quality to be analyzed