New eye solution to improve comfort during retinal injections
Randomized, Controlled, Double-Masked Study to Evaluate the Efficacy of IRX-101 in Reducing Post-Intravitreal Injection Pain and Corneal Epitheliopathy
PHASE2 · iRenix Medical, Inc. · NCT05747430
This study is testing a new eye solution to see if it can make retinal injection procedures more comfortable for patients.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | iRenix Medical, Inc. (industry) |
| Locations | 1 site (Round Rock, Texas) |
| Trial ID | NCT05747430 on ClinicalTrials.gov |
What this trial studies
This randomized, double-masked clinical trial evaluates the safety and tolerability of IRX-101 compared to 5% povidone-iodine in patients receiving intravitreal anti-VEGF injections for retinal disease. Conducted across up to 15 centers in the United States, the study aims to determine if IRX-101 can provide a more comfortable experience for patients undergoing these injections. Participants will be monitored for any adverse effects and overall comfort levels during the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are receiving intravitreal anti-VEGF injections.
Not a fit: Patients with a history of endophthalmitis, uveitis, or those who are monocular may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more comfortable and safer experience for patients receiving retinal injections.
How similar studies have performed: Other studies have explored similar interventions, but the specific use of IRX-101 in this context is novel.
Eligibility criteria
Show full inclusion / exclusion 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. Monocular patients (vision 20/100 or worse in one eye) who are receiving injections in the better seeing eye 4. Current use of viscous lidocaine products for ocular anesthesia prior to IVT 5. Currently receiving intravitreal steroid injections 6. Concurrent participation in another clinical trial 7. Females who are pregnant, planning to become pregnant or lactating
Where this trial is running
Round Rock, Texas
- Edward Wood, MD — Round Rock, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Stephen Smith, MD
- Email: stephen@irenix.com
- Phone: 650-785-1316
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Retinal Disease