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

Irenix Medical

Status and phase: Not yet enrolling; Phase 3

Conditions: Retinal Disease

Treatments: Drug: IRX-101; Drug: Providone-Iodine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05750589

IRX-2022-001

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups

IRX-101

Experimental group

Description:

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

Treatment:

Drug: IRX-101

5% Povidone-iodine

Active Comparator group

Description:

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

Treatment:

Drug: Providone-Iodine