A Study of the Efficacy, Safety, and Pharmacokinetics of a 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome)

Inclusion Criteria:

• Age ≥ 50 years at time of signing Informed Consent Form

• Initial diagnosis of nAMD within 9 months prior to the screening visit

• Previous treatment with at least three anti- vascular endothelial growth factor (VEGF) intravitreal injections for nAMD per standard of care within 6 months priorto the screening visit

• Demonstrated response to prior anti-VEGF intravitreal treatment since diagnosis

• Availability of historical visual acuity data prior to the first anti-VEGF treatmentfor nAMD until the time of study enrollment

• BCVA of 34 letters (approximate 20/200 Snellen equivalent) or better

Exclusion Criteria:

• History of vitrectomy surgery, submacular surgery, or other surgical interventionfor AMD in study eye

• Prior treatment with Visudyne®, external-beam radiation therapy, or transpupillarythermotherapy in study eye

• Previous treatment with corticosteroid intravitreal injection, intraocular deviceimplantation, previous laser (any type) used for AMD treatment in study eye

• Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to theenrollment visit in study eye

• Concurrent conjunctival, Tenon's capsule, and/or scleral condition in thesupero-temporal quadrant of the eye that may affect the implantation, subsequenttissue coverage, and refill-exchange procedure of the PDS implant

• Prior treatment with brolucizumab (at any time prior to the screening visit) ineither eye

• Prior participation in a clinical trial involving any anti-VEGF drugs, within 9months prior to the enrollment visit in either eye

• Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is >0.5 disc area at screening in study eye

• Subfoveal fibrosis or subfoveal atrophy in study eye

• Choroidal neovascularization (CNV) due to other causes, such as ocularhistoplasmosis, trauma, central serous chorio-retinopathy, or pathologic myopia ineither eye

• Retinal pigment epithelial tear in study eye

• Any concurrent intraocular condition that would either require surgical interventionduring the study to prevent or treat visual loss that might result from thatcondition or affect interpretation of study results in study eye

• Active intraocular inflammation in study eye

• History of vitreous hemorrhage in study eye

• History of rhegmatogenous retinal detachment in study eye

• History of retinal tears or peripheral retinal breaks within 3 months prior to theenrollment visit in study eye

• History of pars plana vitrectomy surgery

• Aphakia or absence of the posterior capsule in study eye

• Spherical equivalent of the refractive error demonstrating more than 8 diopters ofmyopia in study eye

• Preoperative refractive error that exceeded 8 diopters of myopia, for Participantswho have undergone prior refractive or cataract surgery in study eye

• Intraocular surgery within 3 months preceding the enrollment visit in study eye

• Uncontrolled ocular hypertension or glaucoma and any such condition the investigatordetermines may require a glaucoma-filtering surgery during a participant'sparticipation in the study in study eye

• History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucomasurgery in study eye

• History of corneal transplant in study eye

• Any history of uveitis requiring treatment in either eye

• Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in eithereye

• Uncontrolled blood pressure

• History of stroke within the last 3 months prior to informed consent

• Atrial fibrillation diagnosed or worsened within the last 3 months prior to informedconsent

• History of myocardial infarction within the last 3 months prior to informed consent,

• History of other disease, metabolic dysfunction, or clinical laboratory findinggiving reasonable suspicion of a disease or condition that contraindicates the useof ranibizumab or placement of the implant and that might affect interpretation ofthe results of the study or renders the participant at high risk of treatmentcomplications in the opinion of the investigator

• Confirmed active systemic infection

• Use of any systemic anti-VEGF agents

• Active cancer within 12 months of enrollment except for appropriately treatedcarcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancerwith a Gleason score of <= 6 and a stable prostate-specific antigen for > 12 months

• Previous participation in any non-ocular disease studies of investigational drugswithin 1 month preceding the informed consent

• Non-functioning non-study eye