Your session is about to expire
← Back to Search
Other
Anti-VEGF Injection for Retinal Disease (COMFORT Trial)
Phase 3
Recruiting
Research Sponsored by iRenix Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately following intraviteral injection
Awards & highlights
COMFORT Trial Summary
This trial tests the safety and effectiveness of a new anti-VEGF injection compared to a standard one.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests IRX-101's safety compared to a common antiseptic (5% povidone-iodine) used before anti-VEGF injections into the eyes. Participants will randomly receive either IRX-101 or povidone-iodine to see which is better tolerated.See study design
What are the potential side effects?
Possible side effects of IRX-101 aren't detailed but may include discomfort similar to those from standard antiseptics like povidone-iodine: irritation at injection site, allergic reactions, and possibly temporary visual disturbances.
COMFORT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ demonstrate a reduction in mean 1-hr post-injection pain scores
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~demonstrate a reduction in mean 1-hr post-injection pain scores
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of post-intravitreal injection eye pain
Secondary outcome measures
Change in post-IVT corneal epitheliopathy as evaluated by corneal fluorescein staining scores
COMFORT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: IRX-101Experimental Treatment1 Intervention
Subjects randomized to IRX-101 will receive the investigational product, IRX-101.
Group II: 5% Povidone-iodineActive Control1 Intervention
Subjects randomized to this arm will receive the standard of care, Providone-iodine, at a concentration of 5%.
Find a Location
Who is running the clinical trial?
iRenix Medical, Inc.Lead Sponsor
2 Previous Clinical Trials
80 Total Patients Enrolled
Stephen Smith, MDStudy ChairFounder
3 Previous Clinical Trials
140 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, planning to become pregnant, or breastfeeding.I am currently getting steroid shots in my eye.I have been diagnosed with uveitis.I have had or currently have an eye infection inside the eyeball.I understand the study and can agree to participate.I am 18 or older and get eye injections for my vision.I have poor vision in one eye and receive injections in my better eye.I am using viscous lidocaine eye drops before eye injections.
Research Study Groups:
This trial has the following groups:- Group 1: IRX-101
- Group 2: 5% Povidone-iodine
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Federal Drug Administration sanctioned the use of IRX-101?
"IRX-101 is perceived to be highly safe, as evidenced by its 3 score on the Power scale. This reflects multiple rounds of data that validate efficacy and safety within Phase 3 trials."
Answered by AI
Are there any opportunities to take part in this clinical experiment currently?
"Affirmative. Documentation available on clinicaltrials.gov reveals that this study, which was advertised since February 22nd 2023, is open to enrollment. The trial necessitates the recruitment of 240 volunteers from a single site."
Answered by AI
How many individuals are being selected to partake in this research?
"Affirmative. According to the information on clinicaltrials.gov, this medical experiment began recruiting patients on February 22nd 2023 and was recently updated March 1st 2023. It is currently looking for 240 people from a single research site."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger