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

Running, not enrolling · Phase 1

Conditions studied: Neovascular Age-related Macular Degeneration, Diabetic Macular Edema, Macular Edema

In brief

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).

Key facts

Study ID

NCT05698329

Run by

AiViva BioPharma, Inc.

People needed

19

Starts

2023-03-02

Expected to finish

2025-04-01

Last updated by the study team

2025-03-06

Who can join

Age: 21 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 CNV is confirmed by 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

You may not qualify if…

• 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
• Uncontrolled IOP, defined as an IOP > 25 mmHg
• Poorly controlled diabetes mellitus defined as hemoglobin A1c (HbA1c) >10% at screening visit
• 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
• Uncontrolled systemic disease or any other condition or therapy that would make the participant unsuitable for the study
• 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)
• History of allergy or hypersensitivity to constituents of the study treatment formulation, topical iodine, ocular antimicrobial solutions, or clinically relevant hypersensitivity to fluorescein

Where it is running

• Retina-Vitreous Associates — Beverly Hills, California, United States
• Orange County Retina — Santa Ana, California, United States
• Verum Research — Eugene, Oregon, United States
• Valley Retina Institute — McAllen, Texas, United States
• Texas Retina Associates — Plano, Texas, United States
• Medical Center Ophthalmology — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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