EffiCacy, Safety and ToLErability of a Novel Ocular ANtiseptic for Ocular Use (CLEAN)

Irenix Medical

Status and phase: Terminated; Phase 3

Conditions: Diabetic Macular Edema; Glaucoma/Closed Angle Glaucoma; Branch Retinal Vein Occlusion

Treatments: Drug: Control; Drug: IRX-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT05127525

IRX-2021-001

Details and patient eligibility

About

This is a randomized, double-masked, multicenter, study to evaluate the efficacy, safety, and tolerability of IRX-101 versus 5% povidone-iodine (PI) in subjects receiving intravitreal anti-VEGF injections. The study will be conducted in up to 30 centers in the United States (US).

Full description

Intravitreal injection therapy (IVT) of anti-vascular endothelial growth factor (VEGF) agents has transformed the treatment landscape of several retinal diseases, including exudative (wet) macular degeneration, retinal vein occlusion, diabetic macular edema, and choroidal neovascularization. The most common adverse effects of IVT occur due to the side effects of Povidone-Iodine 5% (PI; brand name: Betadine® 5%; Alcon, Fort Worth, TX), the antiseptic placed on the ocular surface prior to each injection. PI is nearly universally used to prevent ocular infection (endophthalmitis). PI leads to marked corneal epithelial toxicity in humans,6, 7 resulting in debilitating side effects including decreased visual acuity and pain that can last more than 3 days post-IVT. Post-IVT pain is severe enough to require oral analgesics in up to 30% of patients and is a frequent cause of treatment discontinuation. Therefore, there is an unmet need in ophthalmology for a potent ocular antiseptic with a superior safety profile.

Enrollment: 5 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. Current use of viscous lidocaine products for ocular anesthesia prior to IVT
4. Currently receiving intravitreal steroid injections
5. Concurrent participation in another clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5 participants in 2 patient groups

Test Drug

Experimental group

Description:

IRX-101 drops instilled prior to intravitreal injection

Treatment:

Drug: IRX-101

Control

Active Comparator group

Description:

Povidone-Iodine/Betadine drops instilled prior to intravitreal injection

Treatment:

Drug: Control