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

Phase 3

Not yet recruiting

• Conditions: Retinal Disease
• Interventions: Drug: Providone-Iodine; Drug: IRX-101

• Registration Number: NCT05750589
• Lead Sponsor: iRenix Medical, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-17
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-13
• Study Start: 2025-12-31
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5% Povidone-iodine	Providone-Iodine	Subjects randomized to this arm will receive the standard of care, Providone-iodine, at a concentration of 5%.
IRX-101	IRX-101	Subjects randomized to IRX-101 will receive the investigational product, IRX-101.

Primary Outcome Measures

Name	Time	Method
Assessment of post-intravitreal injection eye pain	Demonstrate a reduction in mean 1-hr post-injection pain scores	Demonstrate the superiority of IRX-101 compared to PI in terms of reducing patient-reported post-intravitreal injection eye pain; pain will be assessed using the visual analog pain scale, a validated patient-reported outcome measure (questionnaire) for assessing patient's subjective pain and discomfort

Secondary Outcome Measures

Name	Time	Method
Change in post-IVT corneal epitheliopathy as evaluated by corneal fluorescein staining scores	Immediately following intraviteral injection	Demonstrate the superiority of IRX-101 compared to PI in terms of reducing corneal epitheliopathy / corneal fluorescein staining post-intravitreal injection; corneal staining will be obtained using validated Oxford Corneal Staining scale of 0 (no staining) to 5 (maximal corneal staining)

Trial Locations

Locations (1)

R. Gary Lane, II MD; 🇺🇸 San Antonio, Texas, United States