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Safety and Tolerability of IRX-101 in Patients Receiving Intravitreal Injections | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE3

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

Randomized, Controlled, Double-Masked Study to Evaluate the Efficacy of IRX-101 in Reducing Post-Intravitreal Pain and Corneal Epitheliopathy

NCT05750589•iRenix Medical, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (1)

R. Gary Lane, II MD

San Antonio, Texas, United States

Key Dates

Start Date

December 31, 2025

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2027

Last Updated

January 13, 2025

Enrollment

240

ESTIMATED participants

Conditions

Retinal Disease

Interventions

IRX-101

DRUG

Providone-Iodine

DRUG

Contacts

Stephen Smith, MD

CONTACT

650-785-1316 stephen@irenix.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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