Safety and Tolerability of IRX-101 in Patients Receiving Intravitreal Injections

Launched by IRENIX MEDICAL, INC. · Feb 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called IRX-101 to see how safe and tolerable it is for patients who are receiving eye injections for retinal diseases. The trial compares IRX-101 to a standard cleaning solution (5% povidone-iodine) used during these injections. It is currently looking for participants aged 18 and older who are willing to follow the study procedures and are receiving these eye injections in one or both eyes.

To be eligible for this trial, participants should not have certain eye conditions, such as endophthalmitis (an eye infection) or uveitis (inflammation of the eye). They also cannot be currently pregnant or breastfeeding. If you decide to participate, you will be part of a study that aims to improve the treatment experience for others with retinal diseases, and you will receive close monitoring throughout the process to ensure your safety.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Capable of giving informed consent
• • 2. Stated willingness to comply with all study procedures and availability for the duration of the study
• • 3. Male or female, ≥ 18 years of age and receiving intravitreal anti-VEGF injections in one or both eyes
• Exclusion Criteria:
• • 1. Current or past diagnosis of endophthalmitis
• • 2. Current diagnosis of uveitis
• • 3. Monocular patients (vision 20/100 or worse in one eye) who are receiving injections in the better seeing eye
• • 4. Current use of viscous lidocaine products for ocular anesthesia prior to IVT
• • 5. Currently receiving intravitreal steroid injections
• • 6. Concurrent participation in another clinical trial
• • 7. Females who are pregnant, planning to become pregnant or lactating