A Study to Assess the Effects of Brolucizumab in Adult Patients With Neovascular Age Related Macular Degeneration

INCLUSION Criteria

• Patients must provide written informed consent before any study related procedures are performed.
• Patients must be 50 years of age or older at Screening/Baseline.

Study eye:

• Active CNV lesions secondary to AMD that affect the central subfield, including retinal angiomatous proliferation (RAP) with a CNV component, confirmed by presence of active leakage from CNV seen by fluorescein angiography and sequellae of CNV, e.g. pigment epithelial detachment (PED), subretinal hemorrhage or sub-retinal pigment epithelium (sub-RPE) hemorrhage, blocked fluorescence, macular edema.
• Intra- and/or subretinal fluid affecting the central subfield of the study eye at Screening/Baseline.
• BCVA between 83 and 23 letters, inclusive, in the study eye at Screening/Baseline using early treatment diabetic retinopathy study (ETDRS) at an initial testing distance of 4 meters.

EXCLUSION Criteria

Ocular conditions:

• Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis) in either eye at Screening/Baseline.
• Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA 25 mmHg on medication or according to the investigator's judgment at Screening/Baseline.
• Aphakia and/or absence of the posterior capsule in the study eye at Screening/Baseline.

Ocular treatments (study eye):

• Patient has received any approved or investigational treatment for nAMD (other than vitamin supplements) in the study eye at any time.
• Intraocular or periocular use of corticosteroids in the study eye during the 6-month period prior to Screening/Baseline.
• Previous penetrating keratoplasty or vitrectomy at any time prior to Screening/Baseline.
• History or evidence of the following in the study eye within the 90-day period prior to Screening/Baseline:
• Intraocular or refractive surgery.
• Previous panretinal photocoagulation.
• Previous submacular surgery, other surgical intervention or laser treatment for nAMD including photodynamic therapy (PDT).

Systemic conditions or treatments:

• End stage renal disease requiring dialysis or renal transplant.
• Systemic medications known to be toxic to the lens, retina or optic nerve (e.g. deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines and ethambutol) used during the 6-month period prior to Screening/Baseline except temporary use for COVID-19 treatment.
• Participation in an investigational drug, biologic, or device study within 30 days or the duration of 5 half-lives of the investigational product (whichever is longer) prior to Screening/Baseline. Note: observational clinical studies solely involving over-the-counter vitamins, supplements, or diets are not exclusionary.
• Systemic anti-VEGF therapy at any time.
• Stroke or myocardial infarction in the 6-month period prior to Screening/Baseline.
• Uncontrolled blood pressure defined as a systolic value ≥ 160 mmHg or diastolic value ≥ 100 mmHg at Screening/Baseline. (In case there is an elevated blood pressure measurement, it should be repeated after 20 minutes. If the repeat measurement is elevated, then the patient is not eligible to be enrolled into the study).
• History of a medical condition (disease, metabolic dysfunction with exception of type 1 or 2 diabetes mellitus, physical examination finding, or clinical laboratory finding) that, in the judgment of the investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product.
• History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
• History of hypersensitivity to any component of the test article, control article, or clinically relevant sensitivit