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 range18 Years

SexALL

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

What they're measuring

Assessment of post-intravitreal injection eye pain

Timeframe: Demonstrate a reduction in mean 1-hr post-injection pain scores

Trial details

NCT IDNCT05750589

SponsoriRenix Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01-31

Contact for this trial

Stephen Smith, MD

650-785-1316 stephen@irenix.com

View on ClinicalTrials.gov More Retinal Disease trials