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

NCT05750589 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: IRX-2022-001
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Disease

Outcome Measures

Primary Outcomes (1)

• Assessment of post-intravitreal injection eye pain

  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

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

Secondary Outcomes (1)

• Change in post-IVT corneal epitheliopathy as evaluated by corneal fluorescein staining scores

  Immediately following intraviteral injection

Study Arms (2)

IRX-101

EXPERIMENTAL

Subjects randomized to IRX-101 will receive the investigational product, IRX-101.

Drug: IRX-101

5% Povidone-iodine

ACTIVE COMPARATOR

Subjects randomized to this arm will receive the standard of care, Providone-iodine, at a concentration of 5%.

Drug: Providone-Iodine

Interventions

IRX-101 DRUG

IRX-101 is a novel ocular anti-septic

IRX-101

Providone-Iodine DRUG

5% Providone-Iodine

5% Povidone-iodine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• iRenix Medical, Inc.: lead

Study Sites (1)

R. Gary Lane, II MD

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Stephen Smith, MD

  Founder

  STUDY CHAIR

Central Study Contacts

Stephen Smith, MD

CONTACT

650-785-1316; stephen@irenix.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Treatment assignment will be unknown (or masked) to the study subjects, the evaluating physician, the Sponsor and its agents (with the exception of personnel performing randomization, unmasked drug accountability study monitors, and corporate compliance staff). The treating physician will be unmasked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to IRX-101 or Providone-Iodine

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 1, 2023
• Study Start: December 31, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

US (1)