Effect of AIV007 by Periocular Administration in Subjects With Macular Edema Secondary to nAMD and DME

Prior treatment

• 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 therapy
• The 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 prescription
• Any 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 Visit
• History of vitreous hemorrhage within 3 months before screening in the study eye
• Participation 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)

Other illness

• Uncontrolled systemic disease or any other condition or therapy that would make the participant unsuitable for the study
• History of allergy or hypersensitivity to constituents of the study treatment formulation, topical iodine, ocular antimicrobial solutions, or clinically relevant hypersensitivity to fluorescein

Lab values

• Poorly controlled diabetes mellitus defined as hemoglobin A1c (HbA1c) \>10% at screening visit

Other

• Uncontrolled intraocular pressure (IOP), defined as an IOP \> 25 mmHg

• General inclusion Criteria:
• Male or female subjects aged 21-90 years (inclusive) at screening
• BCVA 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 responsiveness
• Subject must provide written informed consent before any study-related procedures are performed
• Clear ocular media and adequate pupil dilation in both eyes to permit good-quality photographic imaging
  • nAMD subject
• The active choroidal neovascularization (CNV) is confirmed by fluorescein angiography (FA; evidence of leakage)
• Residual intraretinal or subretinal fluid based on SD-OCT
• CST ≥ 300 µm as assessed by SD-OCT
• Total lesion size \< 10 disc areas (25.4 mm2)
• Absence of geographic atrophy within 200 µm of the fovea
• If subretinal hemorrhage is present, it must be \< 50% of the total CNV lesion and/or not involve the fovea
• If fibrosis is present, it must be \<50% of the total lesion area
  • DME subject
• Diagnosis 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 DME