EO2002 for Corneal Edema

(EMERALD Trial)

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 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 endothelial cells \[mHCECs\]), compared with a placebo injection, in participants with corneal edema caused by corneal endothelial dysfunction.

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

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+