A Phase IV, Multicenter, Open-label Study to Assess Corneal Endothelial Cells in Patients With Neovascular Age-related Macular Degeneration Treated With the Port Delivery System With Ranibizumab (PDS)
This study will assess corneal endothelial cells in participants with nAMD treated with PDS refilled every 24 weeks (Q24W).
∙ Ocular Inclusion Criteria:
• Diagnosis of nAMD prior to screening as determined by the investigator
• Difference of \<10% in ECD at screening between the 2 eyes as measured by specular microscopy and determined by the independent reading center
• Availability of historical visual acuity (VA) data and spectral-domain optical coherence tomography (SD-OCT). Additionally, fluorescein angiography or color fundus photography can both be used to support participant eligibility per protocol at investigator discretion
• Availability of comprehensive historical anti-vascular endothelial growth factor (VEGF) injection data, including agent administered and date of administration from the time of diagnosis, or for at least 2 years prior to screening if diagnosis was made more than 2 years before screening
• Response to at least two prior anti-VEGF IVT injections as determined by the investigator based on the following:
‣ Overall decrease in nAMD disease activity detected on historical or screening OCT
⁃ Stable or improved best-corrected visual acuity (BCVA)
• BCVA of 34 letters (approximate 20/200 Snellen equivalent) or better, using Early Treatment of Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters at screening and enrollment
• All subtypes of nAMD lesions are permissible
• nAMD lesions at the time of diagnosis must involve the macula
• Sufficiently clear ocular media and adequate pupillary dilation to allow for clinical examination and analysis and grading by the central reading center of SD-OCT images