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

NCT ID: NCT05127525

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-15
• Study Completion Date: 2022-01-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Test Drug

IRX-101 drops instilled prior to intravitreal injection

Group Type: EXPERIMENTAL

IRX-101

Intervention Type: DRUG

IRX-101 to prevent infectious endophthalmitis following intravitreal injection therapy (IVT)

Control

Povidone-Iodine/Betadine drops instilled prior to intravitreal injection

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: DRUG

Providone-Iodine Betadine to prevent infectious endophthalmitis following intravitreal injection therapy (IVT)

Interventions

IRX-101

IRX-101 to prevent infectious endophthalmitis following intravitreal injection therapy (IVT)

Intervention Type: DRUG

Control

Providone-Iodine Betadine to prevent infectious endophthalmitis following intravitreal injection therapy (IVT)

Intervention Type: DRUG

Other Intervention Names

Test Arm 1

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

iRenix Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Smith, MD, MS

Role: STUDY_CHAIR

iRenix Medical

Locations

Florida

Tampa, Florida, United States

Countries

United States

Other Identifiers

IRX-2021-001

Identifier Type: -

Identifier Source: org_study_id