Anti-VEGF Injection for Retinal Disease
(COMFORT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to assess the safety and tolerability of a new treatment, IRX-101, for individuals receiving injections for retinal diseases (eye conditions affecting the retina). Participants will be randomly assigned to receive either the new treatment or a standard care solution, 5% povidone-iodine. The study targets those already receiving anti-VEGF eye injections, a common treatment for certain retinal diseases. Ideal candidates for this trial are individuals who regularly receive these injections in one or both eyes. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment option.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the safety of IRX-101 has been studied in individuals with eye conditions such as diabetic retinopathy and macular edema. These studies assess treatment tolerance and monitor side effects. Results so far suggest that participants generally tolerate IRX-101 well, with few serious side effects reported. However, these findings are based on past research. The current trial will provide more information on the safety and tolerability of IRX-101 when used with anti-VEGF injections for retinal diseases.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for retinal diseases, which typically involve injections of anti-VEGF drugs like bevacizumab or ranibizumab, IRX-101 is an investigational product that may offer a new approach. Most treatments work by blocking VEGF, a protein that promotes abnormal blood vessel growth in the retina. However, researchers are excited about IRX-101 because it might provide enhanced efficacy or improved delivery, potentially leading to better outcomes or fewer side effects. This novel approach could be a game-changer for patients, offering a fresh option for managing retinal diseases.
What evidence suggests that this trial's treatments could be effective for retinal disease?
Research has shown that IRX-101, which participants in this trial may receive, may help reduce pain and damage to the eye's surface after eye injections. One study found that patients experienced less discomfort and fewer eye surface problems with IRX-101 compared to other treatments. This suggests that IRX-101 could make eye treatments more comfortable for people with retinal diseases. Although more information is needed, these early results offer promise for those considering this treatment.678910
Who Is on the Research Team?
Stephen Smith, MD
Principal Investigator
Founder
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- IRX-101
- Providone-Iodine
Find a Clinic Near You
Who Is Running the Clinical Trial?
iRenix Medical, Inc.
Lead Sponsor