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

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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

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.

Concurrent participation in another clinical trial

I have had or currently have an eye infection inside the eyeball.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

vumedi.com

vumedi.com/video/asrs-2025-insights-phase-2b3-multicenter-randomized-double-masked-active-comparator-controlled-study/

ASRS 2025 Insights: Phase 2b/3 Multicenter, Randomized ...

... 101 in Reducing Post-Intravitreal Injection Pain and Corneal Toxicity - RELIEF Trial Results ... Diabetic Retinopathy on the Rise. Washington ...

2.

asrs.org

asrs.org/content/documents/detailed-schedule-june-27r.pdf

July 30-August 2, 2025 | Long Beach, California

Longitudinal Quantitative Ultra-Widefield Retinal Leakage Assessment in Diabetic Retinopathy Following a. Single Axitinib Hydrogel (OTX-TKI) ...

3.

synapse.patsnap.com

synapse.patsnap.com/disease/cccdb6765c4e49e3b0434bc18da695e7

Retinal Diseases - Drugs, Targets, Patents

Randomized, Controlled, Double-Masked Study to Evaluate the Efficacy of IRX-101 in Reducing Post-Intravitreal Pain and Corneal Epitheliopathy. NCT06879301.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10863998/

Efficacy and safety of intravitreal anti-VEGF therapy in diabetic ...

Laser treatment has been the gold standard treatment for diabetic macular edema (DME) and proliferative diabetic retinopathy (PDR) for many years. Recently, the ...

5.

retinalphysician.com

retinalphysician.com/issues/2022/may/clinical-trial-update/

Clinical Trial Update May 2022

DRY AMD. NEW: Study: A Masked, Placebo-controlled Study to Assess Iptacopan in Age-related Macular Degeneration.

6.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT05127525/efficacy-safety-and-tolerability-of-a-novel-ocular-antiseptic-for-ocular-use-clean

EffiCacy, Safety and ToLErability of a Novel Ocular ...

Sponsor: iRenix Medical, Inc. Overall Status: Terminated. Phase. 3. Condition. Diabetic Retinopathy. Glaucoma. Diabetic Macular Edema ... safety ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11641122/

Long term efficacy and safety profile of dexamethasone ...

Impact of injection therapy on retinal patients with diabetic macular edema or retinal vein occlusion. Clin Ophthalmol. (2016) 10:939–46. 10.2147/OPTH ...

8.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/nda/2024/761350Orig1s000MultidisciplineR.pdf

761350Orig1s000 - accessdata.fda.gov

Neovascular (Wet) Age-Related Macular Degeneration. • Macular Edema Following Retinal Vein Occlusion. • Diabetic Macular Edema. • Diabetic Retinopathy.

9.

sciencedirect.com

sciencedirect.com/science/article/pii/S1818087624000862

Revamping anti-cGAS-STING therapy via an injectable ...

Retinal vein occlusion, diabetic retinopathy, and retinopathy of prematurity ... retinal microglia and aggravate neovascular age-related macular degeneration in ...

10.

asrs.org

asrs.org/content/documents/detailed-schedule-with-running-changes_july-29.pdf

July 30-August 2, 2025 | Long Beach, California

Longitudinal Quantitative Ultra-Widefield Retinal Leakage Assessment in Diabetic Retinopathy Following a. Single Axitinib Hydrogel (OTX-TKI) ...