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

Diabetic Macular Edema Clinical Trial

— CLEAN  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05127525
• Other study ID #: IRX-2021-001
• Status: Terminated
• Phase: Phase 3
• Start date: November 15, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: May 2022
• Source: iRenix Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Branch Retinal Vein Occlusion
• Diabetic Macular Edema
• Glaucoma
• Glaucoma, Angle-Closure
• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• IRX-101
IRX-101 to prevent infectious endophthalmitis following intravitreal injection therapy (IVT)
• Control
Providone-Iodine Betadine to prevent infectious endophthalmitis following intravitreal injection therapy (IVT)

Locations

Country	Name	City	State
United States	Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
iRenix Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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