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

Last updated: May 17, 2022
Sponsor: iRenix Medical, Inc.
Overall Status: Terminated

Phase

3

Condition

Diabetic Retinopathy

Glaucoma

Diabetic Macular Edema

Treatment

N/A

Clinical Study ID

NCT05127525
IRX-2021-001
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Capable of giving informed consent
  2. Stated willingness to comply with all study procedures and availability for theduration of the study
  3. Male or female, ≥ 18 years of age and receiving intravitreal anti-VEGF injections inone or both eyes

Exclusion

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

Total Participants: 5
Study Start date:
November 15, 2021
Estimated Completion Date:
January 31, 2022

Study 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.

Connect with a study center

  • Florida

    Tampa, Florida 33609-4614
    United States

    Site Not Available

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