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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Randomized, Double-Masked, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of IRX-101 Versus 5% Povidone-Iodine as an Ocular Surface Sterilizer

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

Intervention / Treatment
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* Drug: IRX-101
* Drug: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Capable of giving informed consent Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, ≥ 18 years of age and receiving intravitreal anti-VEGF injections in one or both eyes Exclusion Criteria: Current or past diagnosis of endophthalmitis Current diagnosis of uveitis Current use of viscous lidocaine products for ocular anesthesia prior to IVT Currently receiving intravitreal steroid injections Concurrent participation in another clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Drug<br>IRX-101 drops instilled prior to intravitreal injection | Drug: IRX-101<br>* IRX-101 to prevent infectious endophthalmitis following intravitreal injection therapy (IVT)<br>* Other names: Test Arm 1;|
| Active Comparator: Control<br>Povidone-Iodine/Betadine drops instilled prior to intravitreal injection | Drug: Control<br>* Providone-Iodine Betadine to prevent infectious endophthalmitis following intravitreal injection therapy (IVT)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of infectious endophthalmitis after topical use of IRX-101 combined with IVT | To evaluate the rate of infectious endophthalmitis after topical use of IRX-101 following intravitreal injection therapy (IVT) (% occurrence or rate of population randomized to IRX-101 test arm) | 2 hours post-injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Telephone questionnaire regarding patient-reported post-injection pain | Telephone questionnaire with questions asked of patients regarding patient-reported post-injection pain compared to Providone-Iodine Betadine control group (three questions asked scale of 0 to 10, 0 being no pain to 10 being worst pain) | 2 hours post-injection |