Safety and Tolerability of IRX-101 in Patients Receiving Intravitreal Injections (NCT05750589) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Safety and Tolerability of IRX-101 in Patients Receiving Intravitreal Injections
United States240 participantsStarted 2026-09-01
Plain-language summary
This is a randomized, double-masked study to evaluate the tolerability and safety of IRX-101 versus 5% povidone-iodine (PI) in subjects receiving intravitreal anti-VEGF injections.
Who can participate
Age range
18 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
. Capable of giving informed consent
. Stated willingness to comply with all study procedures and availability for the duration of the study
. Male or female, ≥ 18 years of age and receiving intravitreal anti-VEGF injections in one or both eyes
Exclusion criteria
. Current or past diagnosis of endophthalmitis
. Current diagnosis of uveitis
. Monocular patients (vision 20/100 or worse in one eye) who are receiving injections in the better seeing eye
. Current use of viscous lidocaine products for ocular anesthesia prior to IVT
. Currently receiving intravitreal steroid injections
. Concurrent participation in another clinical trial
. Females who are pregnant, planning to become pregnant or lactating
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.
1This is a Phase 3 trial focused on eye pain after intravitreal injections — does that mean the main goal is improving comfort rather than treating my underlying retinal disease, and if so, how might that affect whether it's the right fit for me?
2Since the trial is listed as 'not yet recruiting,' do you know when it might open, and would it make sense for me to continue with my current injection regimen in the meantime rather than waiting?
3IRX-101 appears to be aimed at reducing pain during or after the injection procedure — can you explain what it actually is, how it would be used, and whether it would replace or just add to what you already do to manage my discomfort?
4Because this is a Phase 3 trial, there should be earlier-phase safety data already available — what is known so far about any side effects or risks of IRX-101 that I should weigh before deciding whether to participate?
5If I were to join this trial, would it change anything about how my retinal disease itself is managed, or would I still receive my standard treatment for the underlying condition at the same time?
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.
What they're measuring
1
Assessment of post-intravitreal injection eye pain
Timeframe: Demonstrate a reduction in mean 1-hr post-injection pain scores