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NCT05750589 | NOT YET RECRUITING | Retinal Disease

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

Condition or disease

Retinal Disease

Intervention/treatment

IRX-101

Providone-Iodine

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 240 participants
Masking : DOUBLE
Masking Description : 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.
Primary Purpose : TREATMENT
Official Title : Randomized, Controlled, Double-Masked Study to Evaluate the Efficacy of IRX-101 in Reducing Post-Intravitreal Pain and Corneal Epitheliopathy
Actual Study Start Date : 2025-12-31
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2027-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
Safety and Tolerability of IRX-101 in Patients Receiving Intravitreal Injections

Location Details

NCT05750589

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How to Participate

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Locations

Not yet recruiting

United States, Texas

R. Gary Lane, II MD

San Antonio, Texas, United States, 78240