EO2002 for Corneal Edema
(EMERALD 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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intracameral injection of EO2002 or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Intracameral injection of 500K magnetic human corneal endothelial cells
Intracameral injection of 150K magnetic human corneal endothelial cells
Intracameral injection of vehicle (no cells)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emmecell
Lead Sponsor
Citations
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 ...
2.
ophthalmologybreakingnews.com
ophthalmologybreakingnews.com/emmetrope-ophthalmics-completes-dosing-in-key-corneal-edema-trialEmmecell 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.
3.
linkedin.com
linkedin.com/posts/ophthalmologytimes_fda-grants-rmat-designation-to-emmecells-activity-7480730577457840128-w9gdOphthalmology 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 ...
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