Safety and Tolerability of IRX-101 in Patients Receiving Intravitreal Injections
ConditionRetinal Disease
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsoriRenix Medical, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Capable of giving informed consent
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, ≥ 18 years of age and receiving intravitreal anti-VEGF injections in one or both eyes
Disqualifiers
Current or past diagnosis of endophthalmitis
Current diagnosis of uveitis
Monocular patients (vision 20/100 or worse in one eye) who are receiving injections in the better seeing eye
Current use of viscous lidocaine products for ocular anesthesia prior to IVT
Trial design
Treatments tested in this trial
- IRX-101
- Providone-Iodine
Treatment groups
240 Participants
are divided into 2 treatment groupsLocations
1R. Gary Lane, II MD78240, San AntonioTexas, United States
Sponsors and collaborators
iRenix Medical, Inc.
Lead sponsor
Source ClinicalTrials.gov