Effect of AIV007 by Periocular Administration in Subjects with Macular Edema Secondary to Neovascular Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME)

Launched by AIVIVA BIOPHARMA, INC. · Jan 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called AIV007, which is given as a gel around the eye to see if it is safe and how well it works for people with certain eye conditions, specifically neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). These conditions can cause vision loss, and the trial aims to find out how long the medication lasts and how it affects those who receive it.

To participate, individuals must be between 21 and 90 years old and have already received specific treatments for their eye conditions in the past. Eligible participants should have a certain level of vision in their affected eye and must not have had other recent treatments that could interfere with the study. During the trial, participants will receive the AIV007 gel and will be monitored to ensure their safety and to track how well the treatment is working. This study is currently looking for volunteers, so if someone meets the criteria and is interested, they could help contribute to important research in eye health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• General inclusion Criteria:
• • 1. Male or female subjects aged 21-90 years (inclusive) at screening
• • 2. BCVA in the study eye at screening and baseline/Day 1: ETDRS letter score ≤ 75 and ≥ 24 (20/32 to 20/330 Snellen equivalent)
• • 3. 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.
• • 4. Subject has documentation of anti-VEGF responsiveness
• • 5. Subject must provide written informed consent before any study-related procedures are performed
• • 6. Clear ocular media and adequate pupil dilation in both eyes to permit good-quality photographic imaging
• • nAMD subject
• • 1. The active CNV is confirmed by FA (evidence of leakage)
• • 2. Residual intraretinal or subretinal fluid based on SD-OCT
• • 3. CST ≥ 300 µm as assessed by SD-OCT
• • 4. Total lesion size \< 10 disc areas (25.4 mm2)
• • 5. Absence of geographic atrophy within 200 µm of the fovea
• • 6. If subretinal hemorrhage is present, it must be \< 50% of the total CNV lesion and/or not involve the fovea
• • 7. If fibrosis is present, it must be \<50% of the total lesion area
• • DME subject
• • 1. Diagnosis of diabetes mellitus (Type 1 or Type 2)
• • 2. Subject has clinically significant DME with central involvement (CST≥300 μm by OCT)
• • 3. The decrease in vision in the study eye was determined by the investigator to be primarily the result of DME
• Exclusion Criteria:
• • 1. 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
• • 2. Uncontrolled IOP, defined as an IOP \> 25 mmHg
• • 3. Poorly controlled diabetes mellitus defined as hemoglobin A1c (HbA1c) \>10% at screening visit
• • 4. 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
• • 5. 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
• • 6. History of vitreous hemorrhage within 3 months before screening in the study eye
• • 7. Uncontrolled systemic disease or any other condition or therapy that would make the participant unsuitable for the study
• • 8. 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)
• • 9. History of allergy or hypersensitivity to constituents of the study treatment formulation, topical iodine, ocular antimicrobial solutions, or clinically relevant hypersensitivity to fluorescein