Anti-VEGF Injection for Retinal Disease
(COMFORT Trial)
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using viscous lidocaine products for eye anesthesia or receiving intravitreal steroid injections.
What data supports the effectiveness of the drug IRX-101 for retinal disease?
Is anti-VEGF injection safe for humans?
Research Team
Stephen Smith, MD
Principal Investigator
Founder
Eligibility Criteria
This trial is for men and women over 18 who are getting eye injections (anti-VEGF) for retinal disease. They must be willing to follow the study rules and be available throughout the study. People can't join if they're in another trial, have very poor vision in one eye, use certain anesthetics, get steroid eye injections, are pregnant or breastfeeding, or have specific eye infections.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either IRX-101 or 5% povidone-iodine during intravitreal injections
Follow-up
Participants are monitored for post-injection pain and corneal epitheliopathy
Treatment Details
Interventions
- IRX-101
- Providone-Iodine
Find a Clinic Near You
Who Is Running the Clinical Trial?
iRenix Medical, Inc.
Lead Sponsor