Anti-VEGF Injection for Retinal Disease

(COMFORT Trial)

Overseen By Stephen Smith, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: iRenix Medical, Inc.

Must be taking: Anti-VEGF

Must not be taking: Intravitreal steroids, Viscous lidocaine

Disqualifiers: Endophthalmitis, Uveitis, Monocular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-injection

240 Participants Needed

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?

Research shows that anti-VEGF injections, like those used in IRX-101, are effective in treating retinal diseases such as macular edema and retinal vein occlusion, helping to improve vision and reduce swelling in the eye. ^{1 2 3 4 5}

Is anti-VEGF injection safe for humans?

Anti-VEGF injections, used for various eye conditions, can have side effects, including serious eye complications and systemic (whole-body) adverse events. While they are effective in treating certain eye diseases, their safety is still being studied, and some risks have been reported. ^{5 6 7 8 9}

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

Stated willingness to comply with all study procedures and availability for the duration of the study

I understand the study and can agree to participate.

I am 18 or older and get eye injections for my vision.

Exclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either IRX-101 or 5% povidone-iodine during intravitreal injections

Immediate post-injection

1 visit (in-person)

Follow-up

Participants are monitored for post-injection pain and corneal epitheliopathy

1 hour post-injection

Treatment Details

Interventions

• IRX-101
• Providone-Iodine

Trial Overview 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.

Participant Groups

Group I: IRX-101 Experimental Treatment 1 Intervention

Subjects randomized to IRX-101 will receive the investigational product, IRX-101.

Group II: 5% Povidone-iodine Active Control 1 Intervention

Subjects randomized to this arm will receive the standard of care, Providone-iodine, at a concentration of 5%.

Who Is Running the Clinical Trial?

iRenix Medical, Inc.

Lead Sponsor

Trials

3

Recruited

320+

Findings from Research

A systematic review of 21 studies found that intravitreal anti-VEGF treatments do not significantly increase the risk of systemic adverse events compared to control treatments, indicating their general safety for patients with conditions like age-related macular degeneration.

However, caution is advised for older patients receiving ranibizumab, as it may be associated with a higher risk of nonocular hemorrhage, particularly in those with age-related macular degeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of Systematic Reviews and Meta-analyses on Systemic Adverse Events Associated With Intravitreal Anti-Vascular Endothelial Growth Factor Medication Use. Thulliez, M., Angoulvant, D., Pisella, PJ., et al.[2019]

A global survey involving 70 centers and 7113 injections of intravitreal bevacizumab (Avastin) reported adverse events in only 0.21% of cases, indicating a low incidence of complications associated with this treatment.

The findings suggest that intravitreal bevacizumab is a safe option for treating neovascular and exudative ocular diseases, with no significant increase in drug-related ocular or systemic adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The International Intravitreal Bevacizumab Safety Survey: using the internet to assess drug safety worldwide. Fung, AE., Rosenfeld, PJ., Reichel, E.[2022]

A systematic review of 14,866 intravitreous injections showed that the risk of serious adverse events, particularly endophthalmitis, is low, with a prevalence of 0.3% per injection and 0.9% per eye.

Despite the low overall risk, careful injection technique and post-injection monitoring are crucial, as rare complications can lead to permanent vision loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risks of intravitreous injection: a comprehensive review. Jager, RD., Aiello, LP., Patel, SC., et al.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Anti-VEGF treatment of macular edema associated with retinal vein occlusion: patterns of use and effectiveness in clinical practice (ECHO study report 2). [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

The ideal intravitreal injection setting: office, ambulatory surgery room or operating theatre? A narrative review and international survey. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Outcomes in patients with retinal vein occlusion with good baseline visual acuity. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Combination intravitreal anti-vascular endothelial growth factor inhibitors and macular laser photocoagulation relative to intravitreal injection monotherapy in macular oedema secondary to retinal vein occlusion: a meta-analysis of randomized controlled trials. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Adverse events and complications associated with intravitreal injection of anti-VEGF agents: a review of literature. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Overview of Systematic Reviews and Meta-analyses on Systemic Adverse Events Associated With Intravitreal Anti-Vascular Endothelial Growth Factor Medication Use. [2019]

7. England pubmed.ncbi.nlm.nih.gov

The International Intravitreal Bevacizumab Safety Survey: using the internet to assess drug safety worldwide. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Issues with Intravitreal Administration of Anti-VEGF Drugs. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Risks of intravitreous injection: a comprehensive review. [2022]