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

Part of paid clinical trials in San Antonio, Texas.

Sponsor
iRenix Medical, Inc.
Study ID
NCT05750589
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Retinal Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • IRX-101 — DRUG
    IRX-101 is a novel ocular anti-septic
  • Providone-Iodine — DRUG
    5% Providone-Iodine

Study Details

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.

Key Dates

Start date
Sep 1, 2026
Status verified
Mar 2026
Primary completion
Jan 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IRX-101
    Subjects randomized to IRX-101 will receive the investigational product, IRX-101.
  • Active Comparator: 5% Povidone-iodine
    Subjects randomized to this arm will receive the standard of care, Providone-iodine, at a concentration of 5%.

Primary Outcome Measure

Assessment of post-intravitreal injection eye pain [ Time Frame: Demonstrate a reduction in mean 1-hr post-injection pain scores ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
R. Gary Lane, II MDSan AntonioTexas78240
Francisco Angueira
800-833-5921

Find similar trials in San Antonio, TX

By research site
R. Gary Lane, II MD· San Antonio, TX

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