Brolucizumab for CNV Associated With Pathologic Myopia

Inclusion Criteria:

• Able to read (or, if unable to read due to visual impairment, be read to verbatim bythe person administering the informed consent form or a family member) and understandthe informed consent form and willing to sign the informed consent form.
• Signed informed consent form.
• Men and women ≥ 18 years of age.
• Willing, committed, and able to return for all clinic visits and complete allstudy-related procedures.
• Myopia of greater than or equal to -6 D OR axial length of greater than (if thespherical myopic equivalent is <6.0 diopters, then the patient should have myopicchanges in the macula: lacquer cracks, focal chorioretinal atrophy, posteriorstaphyloma) or equal to 26.5 mm.
• Active subfoveal or juxtafoveal (within 1 to 199 μm of the center of the fovea) CNVsecondary to pathologic myopia as defined by leakage on FA.
• Transparent optical media and possibility to mydriasis.
• Best corrected visual acuity at least 20/200 Equivalent of Snellen (ETDRS).

Exclusion Criteria:

• Ocular media of insufficient quality to obtain fundus and OCT images in the study eye
• Recurrent mCNV in the study eye
• History or presence of CNV with an origin other than pathologic myopia in the studyeye
• Ocular inflammation or external ocular inflammation in the study eye
• Concurrent disease in the study eye that would compromise BCVA or require medical orsurgical intervention during the study period
• Any ocular disorder in the study eye that, in the opinion of the investigator, mayconfound interpretation of the study results
• Significant scarring or atrophy in the fovea that indicates substantial irreversiblevision loss in the study eye
• History of idiopathic or autoimmune-associated uveitis in either eye
• Evidence at examination of infectious blepharitis, keratitis, scleritis, orconjunctivitis in either eye or current treatment for serious systemic infection
• Vitreomacular traction or traction retinal detachment, epiretinal membrane in eithereye
• Any iris neovascularization and/or vitreous hemorrhage in either eye
• Uncontrolled glaucoma, or previous filtration surgery in either eye
• Prior and concomitant treatments
• Any prior or concomitant treatment with another investigational agent for mCNV in thestudy eye.
• Any previous panretinal photocoagulation or subfoveal thermal laser therapy in thestudy eye.
• Any prior treatment with photodynamic therapy in the study eye.
• Cataract surgery within 3 months prior to Day 1 in the study eye.
• Yttrium-aluminum-garnet laser capsulotomy within 2 months prior to Day 1 in the studyeye.
• Any other intraocular surgery within 3 months prior to Day 1 in the study eye.
• History of vitreoretinal surgery and/or scleral buckle surgery in the study eye.
• Any prior treatment with anti-VEGF agents
• Previous use of intraocular or periocular corticosteroids in either eye within 3months prior to Day 1
• Previous assignment to treatment during this study
• Uncontrolled hypertension
• History of cerebrovascular disease or myocardial infarction within 6 months prior toBaseline/Day 1
• History of other disease, metabolic dysfunction, physical examination finding, orclinical laboratory finding giving reasonable suspicion of a disease or condition thatcontraindicates the use of an investigational drug, may affect interpretation of theresults of the study, or renders the subject at high risk from treatment complications
• Women of childbearing potential without contraception, women who intend to breastfeedduring the study. All subjects (both men and women) of childbearing potential who areunwilling to use adequate birth control measures during the course of the study.
• Renal failure requiring dialysis or renal transplant
• Participation in an investigational study within 30 days prior to Screening/Visit 1that involved treatment with any drug (excluding vitamins and minerals) or device
• Known serious allergy to the fluorescein sodium for injection in angiography orVerteporfin
• Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality