Corneal EdemaPhase 2EMERALDNCT07729137

Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction

A Phase 2 study testing 150K cells and 500K cells in people with Corneal Edema and Fuchs, run by Emmecell at 10 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Corneal Edema, Fuchs, Fuchs Dystrophy
What is being tested?: 150K cells and 500K cells
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 121 participants
Where: 10 sitesUnited States
Study dates: Oct 2026to Feb 2028
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Symptomatic central corneal edema that is primarily responsible for loss of vision associated with endothelial dysfunction which may be secondary to Fuchs corneal dystrophy or pseudophakic bullous keratopathy.
Early Treatment Diabetic Retinopathy Study (ETDRS)-best-corrected distance visual acuity between 20 and 65 letters inclusive (≥ 20 and ≤ 65 letters)
Central corneal thickness ≥ 600 μm and ≤ 1,000 μm, OR Medical Monitor review and approval based on either:
Historical CCT increased by ≥ 50 μm OR
Findings of edema by corneal tomography or Anterior Segment Optical Coherence Tomography (AS-OCT).
Participant is considered a surgical candidate for full-thickness corneal transplantation or endothelial (partial thickness) keratoplasty (EK) consistent with standard-of-care indications.

Who cannot join

Corneal disease in either eye (other than corneal endothelial dysfunction secondary to Fuchs dystrophy or pseudophakic bullous keratopathy) including active or prior herpetic ocular infection, severe dry eye disease (e.g., Sjogren's), or active inflammation.
Central corneal scarring from trauma, burns, or infection, or band keratopathy
History of keratoconus or other corneal ectasia (e.g., keratoglobus and pellucid marginal degeneration).
Visually significant cataract, that may limit the participant's ability to demonstrate treatment-related improvement in BCVA.
Presence of an anterior chamber, sutured, or scleral-fixated intraocular lens.
Presence of a multifocal or diffractive intraocular lens.

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Prior vitrectomy.
Corneal refractive surgery.
Descemet dettachment
Minimally invasive glaucoma surgery (MIGS), intraocular pressure (IOP)- lowering implant (e.g., Durysta® or iDose®), or any incisional glaucoma surgery (e.g., trabeculectomy, glaucoma drainage implant).

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Operations - Emmecell contact

650-769-4232

clinicaltrials@emmecell.com

City, postcode or hospital

Sites recruiting now only

10 sites in 1 country

United States10 sites, 10 recruiting

Atlanta, Georgia
Atlanta, Georgia, 30339
Atlanta, Georgia Location, 650-769-4232, clinicaltrials@emmecell.com
Not yet recruiting
Carmel, Indiana
Carmel, Indiana, 46032
Carmel, Indiana Location, 650-769-4232, clinicaltrials@emmecell.com
Recruiting
Chicago, Illinois
Chicago, Illinois, 60612
Chicago, Illinois Location, 650-769-4232, clinicaltrials@emmecell.com
Not yet recruiting
Garden City, NY
Garden City, New York, 11530
Garden City, NY Location, 650-769-4232, clinicaltrials@emmecell.com
Not yet recruiting
Kansas City, Missouri
Kansas City, Missouri, 64133
Kansas City, Missouri Location, 650-769-4232, clinicaltrials@emmecell.com
Not yet recruiting
Largo, Florida
Largo, Florida, 33770
Largo, Florida Location, 650-769-4232, clinicaltrials@emmecell.com
Not yet recruiting
Minnetonka, Minnesota
Minnetonka, Minnesota, 55305
Minnetonka, Minnesota Location, 650-769-4232, clinicaltrials@emmecell.com
Not yet recruiting
Overland Park, Kansas
Overland Park, Kansas, 66204
Overland Park, Kansas Location, 650-769-4232, clinicaltrials@emmecell.com
Not yet recruiting
Salt Lake City, Utah
Salt Lake City, Utah, 84107
Salt Lake City, Utah Location, 650-769-4232, clinicaltrials@emmecell.com
Not yet recruiting
Torrance, California
Torrance, California, 90505
Torrance, CA Location, 650-769-4232, clinicaltrials@emmecell.com
Not yet recruiting

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 2 Study of EO2002 in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction (EMERALD)

Read the detailed description

This study is designed to evaluate the safety and efficacy of EO2002, an investigational magnetic human corneal endothelial cell (mHCEC) therapy, in adults with corneal edema secondary to corneal endothelial dysfunction. Participants will be randomized to receive a single intracameral injection of one of two doses of EO2002 (150,000 or 500,000 cells) or placebo.

The study will compare the effects of EO2002 on visual acuity and corneal thickness, while also evaluating safety over a 52-week follow-up period. Approximately 105 participants will be treated at multiple sites in the United States.

Conditions: Corneal Edema, Fuchs, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy, Endothelial Corneal Dystrophy, Corneal Endothelial Decompensation
Being tested: 150K cells, 500K cells, Placebo
Keywords: FECD, PBK, Corneal endothelial dysfunction, Fuchs Dystrophy, Fuchs, Corneal edema
Medical subject headings: Corneal Edema, Fuchs' Endothelial Dystrophy, Corneal endothelial dystrophy type 2, Corneal Endothelial Cell Loss, Corneal Endothelial Dystrophy 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

150K cellsBiological
Intracameral injection - 150K dose
500K cellsBiological
Intracameral injection - 500K dose
PlaceboProcedure or surgery
Intracameral injection of vehicle

Study groups in NCT07729137
Study group	Role	What they receive
150K cells - EO2002	Experimental	Intracameral injection of 150K magnetic human corneal endothelial cells Receives: Biological: 150K cells
500K cells - EO2002	Experimental	Intracameral injection of 500K magnetic human corneal endothelial cells Receives: Biological: 500K cells
Placebo	Placebo comparator	Intracameral injection of vehicle (no cells) Receives: Procedure: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

BCVA
Proportion of study eyes achieving ≥ 15-letter best-corrected visual acuity (BCVA) improvement at 26 weeks post-treatment as compared to baseline.
Measured: 26 weeks

Secondary outcomes (4)

BCVA
Mean change in BCVA compared to baseline
Measured: 26 weeks
CCT
Mean change in CCT compared to baseline
Measured: 26 weeks
BCVA
Proportion of subjects achieving ≥10-letter BCVA improvement from baseline
Measured: 26 weeks
BCVA
Proportion of subjects achieving ≥70 letters (ETDRS)
Measured: 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2026Feb 2028

First posted27 Jul 2026
Study startOct 2026 (estimated)
Primary completionAug 2027 (estimated)
Study completionFeb 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Corneal EdemaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 121 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07729137
Sponsor's protocol ID: EMME-002
Acronym: EMERALD
Status last verified: Jul 2026
First submitted: 22 Jul 2026
Last updated: 9 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Clinical Operations - Emmecell

650-769-4232

clinicaltrials@emmecell.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction
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The Belgian Endothelial Surgical Transplant of the Cornea
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The Effect of Topical Rho-kinase Inhibitors on Corneas of Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy, Cataract
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Plasma Rich in Growth Factors in Corneal Endothelial Transplantation
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EndoArt® Implantation in Subjects With Chronic Corneal Edema - US Study
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