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 range
21 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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)