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

Phase 3Not Yet RecruitingNCT05750589

iRenix Medical, Inc.240 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

240

Conditions

Retinal Disease

Interventions

IRX-101DRUG

IRX-101 is a novel ocular anti-septic

Providone-IodineDRUG

5% Providone-Iodine

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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

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)

Time frame: Immediately following intraviteral injection

Central Contacts

Stephen Smith, MD

CONTACT

650-785-1316 stephen@irenix.com

Data from ClinicalTrials.gov

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