Effect of AIV007 by Periocular Administration in Subjects with Macular Edema Secondary to Neovasc… (NCT05698329) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Effect of AIV007 by Periocular Administration in Subjects with Macular Edema Secondary to Neovascular Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME)
United States19 participantsStarted 2023-03-02
Plain-language summary
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).
Who can participate
Age range21 Years – 90 Years
SexALL
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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
✓. The active CNV is confirmed by FA (evidence of leakage)
✓. Residual intraretinal or subretinal fluid based on SD-OCT
Exclusion 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 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)