121 Participants NeededMy employer runs this trial

EO2002 for Corneal Edema

(EMERALD Trial)

Recruiting at 10 trial locations
CO
Overseen ByClinical Operations - Emmecell
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Emmecell
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called EO2002 for individuals with corneal edema, a condition where the cornea swells due to issues with corneal cells. The study compares different doses of EO2002, which uses special cells, to a placebo to evaluate its effectiveness and safety. It suits those experiencing vision loss from corneal edema related to conditions like Fuchs corneal dystrophy or pseudophakic bullous keratopathy and who are considering corneal surgery. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in corneal edema treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that EO2002, a treatment for corneal swelling, has been tested for safety and tolerability. In earlier studies, patients received a single injection of EO2002. This treatment uses magnetic human corneal endothelial cells (mHCECs) to enhance eye health.

Results from these studies suggest that EO2002 is generally well-tolerated. The use of magnets to deliver the cells does not appear to harm the cells or patients. Unwanted side effects were not commonly reported, indicating that EO2002 might be a safe option for those with corneal swelling.

It is important to note that EO2002 is still under investigation, so not all risks may be known yet. However, current evidence appears promising for its safety and tolerability.12345

Why do researchers think this study treatment might be promising for corneal edema?

Unlike the standard treatments for corneal edema, which often involve eye drops or surgery, EO2002 is an innovative approach using magnetic human corneal endothelial cells. This treatment involves an intracameral injection, directly introducing 150K or 500K cells into the eye, aiming to repair and regenerate the damaged corneal tissue. Researchers are excited because this method could potentially restore vision by directly addressing the underlying cell loss, offering a more direct and regenerative solution compared to current options.

What evidence suggests that EO2002 might be an effective treatment for corneal edema?

Research has shown that EO2002 may help treat corneal edema, a condition involving swelling in the eye due to issues with the eye's inner layer. In this trial, participants will receive different doses of EO2002; some will receive an intracameral injection of 150K magnetic human corneal endothelial cells, while others will receive 500K cells. Earlier studies demonstrated that patients treated with special magnetic cells, like those in EO2002, experienced significant vision improvements. Specifically, nine out of 21 patients could see three lines better on an eye chart, indicating clearer vision. Importantly, no safety issues emerged after 12 months. The magnetic cells help direct the treatment to the correct part of the eye, potentially enhancing its effectiveness. These findings suggest that EO2002 could improve vision for people with corneal edema.24678

Who Is on the Research Team?

NK

Noelia Kunzevitzky, PhD

Principal Investigator

Emmecell

Are You a Good Fit for This Trial?

This trial is for people with corneal swelling (edema) due to problems with the inner layer of their cornea, such as Fuchs' dystrophy or pseudophakic bullous keratopathy. Participants must meet specific medical criteria set by the study and not have other eye conditions that could interfere.

Inclusion Criteria

ETDRS-best-corrected distance visual acuity between 20 and 65 letters inclusive (≥ 20 and ≤ 65 letters)
I am eligible for a corneal transplant surgery based on standard medical guidelines.
I have vision loss from corneal swelling due to Fuchs dystrophy or prior cataract surgery.
See 1 more

Exclusion Criteria

I have had a vitrectomy surgery on my eye.
Presence of an anterior chamber, sutured, or scleral-fixated intraocular lens
Presence of a multifocal or diffractive intraocular lens
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intracameral injection of EO2002 or placebo

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks
Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • EO2002

Trial Overview

The study tests a single injection of EO2002—magnetic human corneal endothelial cells—at two different doses (150,000 or 500,000 cells), compared to a placebo injection. The goal is to see if EO2002 can safely reduce corneal swelling.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: 500K cells - EO2002Experimental Treatment1 Intervention
Group II: 150K cells - EO2002Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emmecell

Lead Sponsor

Trials
4
Recruited
120+

Citations

1.

dev-multi-sponsor-trials.xogene.com

dev-multi-sponsor-trials.xogene.com/trials/7729137

Study of EO2002 in Subjects With Corneal Edema Secondary ...

This study will evaluate the safety and effectiveness of a single injection of EO2002 at one of two dose levels (150,000 or 500,000 magnetic human corneal ...

Emmecell Completes Dosing in Key Corneal Edema Trial

The trial, a randomized, double-masked, multi-center study, is set to reveal its topline results in the second half of 2024.

Ophthalmology Times' Post

EO2002, its investigational magnetic human corneal endothelial cell therapy for corneal edema secondary to endothelial dysfunction.

Magnetic Cell Therapy for Corneal Disease

Even though the patients had long-term scarring, nine out of 21 gained three lines or more of vision, and there were no safety issues after 12 ...

Human Corneal Endothelial Cell Transplantation in a Human ...

HCEC transplantation into the eyes of human recipients was investigated by subjecting anterior segments in organ culture to an external magnetic field. Light ...

Emmecell is developing an investigational, in‑office cell ...

Emmecell is developing an investigational, in‑office cell therapy (E02002) for corneal endothelial disease like Fuchs' dystrophy.

Engineering of Human Corneal Endothelial Cells In Vitro - PMC

Human corneal endothelial cells are responsible for controlling corneal transparency, however they are notorious for their limited proliferative capability.

Emmecell Completes Last Patient Last Visit for Proof-of- ...

EO2002 was studied in EMME-001 as a treatment for corneal edema without the need for invasive and high-risk surgical procedures, such as corneal ...