IRX-101 for Retinal Disease

Edward Wood, MD, Round Rock, TX
Retinal DiseaseIRX-101 - Drug
Eligibility
18+
All Sexes

Study Summary

This trial will compare the safety and tolerability of a new antiseptic (IRX-101) vs. standard antiseptic (PI) for eye injections in up to 15 US centers.

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Similar Trials

1
BMS-986403
1
SYNCAR-001 + STK-009
1
Treatment Group A (ACE1831)

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 1-hour post-administration

1-hour post-administration
Patient-reported post-injection pain scores
Immediately following intraviteral injection
Mean corneal fluorescein staining scores

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
BMS-986403
1
SYNCAR-001 + STK-009
1
Treatment Group A (ACE1831)

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2 Treatment Groups

5% Povidone-iodine
1 of 2
IRX-101
1 of 2

Active Control

Experimental Treatment

240 Total Participants · 2 Treatment Groups

Primary Treatment: IRX-101 · No Placebo Group · Phase 3

IRX-101
Drug
Experimental Group · 1 Intervention: IRX-101 · Intervention Types: Drug
5% Povidone-iodine
Drug
ActiveComparator Group · 1 Intervention: Providone-Iodine · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1-hour post-administration

Who is running the clinical trial?

iRenix Medical, Inc.Lead Sponsor
2 Previous Clinical Trials
245 Total Patients Enrolled
Stephen Smith, MDStudy ChairFounder
3 Previous Clinical Trials
305 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are 18 years or older and receiving injections in one or both eyes to treat a condition related to abnormal blood vessel growth.
References

Frequently Asked Questions

Has the Food & Drug Administration sanctioned IRX-101 for clinical use?

"IRX-101's safety record is highly reliable, and thus it merited a 3 on our team at Power's scale of 1 to 3. This medication has been subject to data collection in multiple trials that suggest efficacy as well as numerous rounds of testing which point towards its security profile." - Anonymous Online Contributor

Unverified Answer

Is this experiment currently recruiting participants?

"This clinical trial is open for recruitment, with the initial post date having been February 22nd 2023 and a recent edit on March 1st of the same year." - Anonymous Online Contributor

Unverified Answer

How many research participants are currently engaging in this experiment?

"Indeed, the clinicaltrials.gov page for this study confirms that it is actively enlisting participants. The experiment was first posted on February 22nd 2023 and has been updated as recently as March 1st of the same year. 240 patients are being sought from a single research centre." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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