Retinal Disease
Conditions
Brief summary
This is a randomized, double-masked study to evaluate the tolerability and safety of IRX-101 versus 5% povidone-iodine (PI) in subjects receiving intravitreal anti-VEGF injections. The study will be conducted in up to 15 centers in the United States (US).
Interventions
DRUGIRX-101
IRX-101 is a novel ocular anti-septic
DRUGProvidone-Iodine
5% Providone-Iodine
Sponsors
iRenix Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Treatment assignment will be unknown (or masked) to the study subjects, the evaluating physician, the Sponsor and its agents (with the exception of personnel performing randomization, unmasked drug accountability study monitors, and corporate compliance staff). The treating physician will be unmasked.
Intervention model description
Subjects will be randomized to IRX-101 or Providone-Iodine
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of new drug | 1-hour and 1-week post-treatment | Safety will be measured via slit lamp and fundoscopic examinations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean corneal fluorescein staining scores | Immediately following intraviteral injection | Compare mean corneal fluorescein staining scores obtained after IVT in the IRX-101 and standard of care groups; corneal staining will be obtained using the validated Oxford Corneal Staining scale of 0 (no staining) to 5 (maximal staining) |
| Patient-reported post-injection pain scores | 1-hour post-administration | Compare mean patient-reported post-injection pain scores 1-hour post-administration; pain will be assessed using the visual analog pain scale, a validated patient-reported outcome measure (questionnaire) for assessing patient's subjective pain and discomfort |
Countries
United States
Contacts
STUDY_CHAIRStephen Smith, MD
Founder
Outcome results
None listed