Effect of AIV007 by Periocular Administration in Subjects With nAMD or DME

To determine safety, pharmacokinetics, and duration of effect of periocularly administered AIV007 gel suspension in subjects with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME).

Inclusion Criteria:General inclusion Criteria:Male or female subjects aged 21-90 years (inclusive) at screeningBCVA in the study eye at screening and baseline/Day 1: ETDRS letter score ≤ 75 and ≥ 24 (20/32 to 20/330 Snellen equivalent)Subject must have received treatment within the 24 months before screening with intravitreal (IVT) injections of an anti-VEGF agent with the last anti-VEGF injection in the study eye being at least 6 weeks (42 days) before baseline/Day 1.Subject has documentation of anti-VEGF responsivenessSubject must provide written informed consent before any study-related procedures are performedClear ocular media and adequate pupil dilation in both eyes to permit good-quality photographic imagingnAMD subjectThe active CNV is confirmed by FA (evidence of leakage)Residual intraretinal or subretinal fluid based on SD-OCTCST ≥ 300 µm as assessed by SD-OCTTotal lesion size < 10 disc areas (25.4 mm2)Absence of geographic atrophy within 200 µm of the foveaIf subretinal hemorrhage is present, it must be < 50% of the total CNV lesion and/or not involve the foveaIf fibrosis is present, it must be <50% of the total lesion areaDME subjectDiagnosis of diabetes mellitus (Type 1 or Type 2)Subject has clinically significant DME with central involvement (CST≥300 μm by OCT)The decrease in vision in the study eye was determined by the investigator to be primarily the result of DMEExclusion Criteria:Previous treatment for nAMD or DME in the study eye other than standard-of-care anti-VEGF IVT injection, e.g., cell therapy, brachytherapy, gene therapyUncontrolled IOP, defined as an IOP > 25 mmHgPoorly controlled diabetes mellitus defined as hemoglobin A1c (HbA1c) >10% at screening visitThe spherical equivalent for refractive error in the study eye of worse than 8.0 diopters of myopia (before cataract or refractive surgery) per the current prescriptionAny history of active bacterial, viral, fungal, or parasitic ocular or periocular infection, or intraocular inflammation in either eye within the 30 days before the screening VisitHistory of vitreous hemorrhage within 3 months before screening in the study eyeUncontrolled systemic disease or any other condition or therapy that would make the participant unsuitable for the studyParticipation in any investigational study within 60 days before the screening visit, or planned use of an investigational product or device during the study; any exposure to a prior investigational drug product must be fully washed out (at least 5 half-lives)History of allergy or hypersensitivity to constituents of the study treatment formulation, topical iodine, ocular antimicrobial solutions, or clinically relevant hypersensitivity to fluorescein