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

Phase 3

Terminated

• Conditions: Diabetic Macular Edema; Glaucoma/Closed Angle Glaucoma; Branch Retinal Vein Occlusion
• Interventions: Drug: IRX-101; Drug: Control

• Registration Number: NCT05127525
• Lead Sponsor: iRenix Medical, Inc.

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-10-19
• Study Start: 2021-11-15
• Study First Submitted QC: 2021-11-18
• Study First Posted: 2021-11-19
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Drug	IRX-101	IRX-101 drops instilled prior to intravitreal injection
Control	Control	Povidone-Iodine/Betadine drops instilled prior to intravitreal injection

Primary Outcome Measures

Name	Time	Method
Incidence of infectious endophthalmitis after topical use of IRX-101 combined with IVT	2 hours post-injection	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)

Secondary Outcome Measures

Name	Time	Method
Telephone questionnaire regarding patient-reported post-injection pain	2 hours post-injection	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)

Trial Locations

Locations (1)

Florida; 🇺🇸 Tampa, Florida, United States