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RecruitingNCT07729137EMERALDUpdated Oct 9, 2026

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

A Phase 2 interventional study of 150K cells and 500K cells in Corneal Edema, Fuchs and Fuchs Dystrophy, sponsored by Emmecell. Recruiting at 10 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by Emmecell · Phase 2, Interventional, and Treatment

Updated Oct 9, 2026Now RecruitingStart date moved+2 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
121
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Corneal Edema
  • Fuchs
  • Fuchs Dystrophy
  • Fuchs' Endothelial Dystrophy
  • Endothelial Corneal Dystrophy
  • Corneal Endothelial Decompensation
  • Corneal Endothelial Cell Loss
  • Corneal Endothelial Disorder
  • Corneal Endothelial Dystrophy 1
  • Endothelial Cell Loss, Corneal
  • Pseudophakic Bullous Keratopathy
  • Pseudophakic Bullous Keratopathy (PBK)

Keywords

  • FECD
  • PBK
  • Corneal endothelial dysfunction
  • Fuchs Dystrophy
  • Fuchs
  • Corneal edema
03

In context

Corneal Edema

39 studies on the registry are indexed under Corneal Edema; 8 are open to participants now.

This study's planned enrollment of 121 is above the median of 52 across 31 interventional studies indexed under Corneal Edema.

Browse Corneal Edema studies →

Lead sponsor

Emmecell is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  1. 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.
  2. Early Treatment Diabetic Retinopathy Study (ETDRS)-best-corrected distance visual acuity between 20 and 65 letters inclusive (≥ 20 and ≤ 65 letters)
  3. Central corneal thickness ≥ 600 μm and ≤ 1,000 μm, OR Medical Monitor review and approval based on either:

    1. Historical CCT increased by ≥ 50 μm OR
    2. Findings of edema by corneal tomography or Anterior Segment Optical Coherence Tomography (AS-OCT).
  4. Participant is considered a surgical candidate for full-thickness corneal transplantation or endothelial (partial thickness) keratoplasty (EK) consistent with standard-of-care indications.

Key Exclusion Criteria:

  1. 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.
  2. Central corneal scarring from trauma, burns, or infection, or band keratopathy
  3. History of keratoconus or other corneal ectasia (e.g., keratoglobus and pellucid marginal degeneration).
  4. Visually significant cataract, that may limit the participant's ability to demonstrate treatment-related improvement in BCVA.
  5. Presence of an anterior chamber, sutured, or scleral-fixated intraocular lens.
  6. Presence of a multifocal or diffractive intraocular lens.
  7. Prior vitrectomy.
  8. Corneal refractive surgery.
  9. Descemet dettachment
  10. 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).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
121 participants (estimated)

Study arms

  • Experimental
    150K cells - EO2002

    Intracameral injection of 150K magnetic human corneal endothelial cells

    Biological: 150K cells

  • Experimental
    500K cells - EO2002

    Intracameral injection of 500K magnetic human corneal endothelial cells

    Biological: 500K cells

  • Placebo comparator
    Placebo

    Intracameral injection of vehicle (no cells)

    Procedure: Placebo

Interventions

  • Biological150K cells

    Intracameral injection - 150K dose

  • Biological500K cells

    Intracameral injection - 500K dose

  • ProcedurePlacebo

    Intracameral injection of vehicle

06

What researchers measure

Primary outcomes

  1. BCVA

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

    Time frame: 26 weeks

Secondary outcomes

  1. BCVA

    Mean change in BCVA compared to baseline

    Time frame: 26 weeks

  2. CCT

    Mean change in CCT compared to baseline

    Time frame: 26 weeks

  3. BCVA

    Proportion of subjects achieving ≥10-letter BCVA improvement from baseline

    Time frame: 26 weeks

  4. BCVA

    Proportion of subjects achieving ≥70 letters (ETDRS)

    Time frame: 26 weeks

07

Study locations

1 of 10 sites recruiting
  • Torrance, California
    Torrance, California 90505, United States
    Not yet recruiting
  • Largo, Florida
    Largo, Florida 33770, United States
    Not yet recruiting
  • Atlanta, Georgia
    Atlanta, Georgia 30339, United States
    Not yet recruiting
  • Chicago, Illinois
    Chicago, Illinois 60612, United States
    Not yet recruiting
  • Carmel, Indiana
    Carmel, Indiana 46032, United States
    Recruiting
  • Overland Park, Kansas
    Overland Park, Kansas 66204, United States
    Not yet recruiting
  • Minnetonka, Minnesota
    Minnetonka, Minnesota 55305, United States
    Not yet recruiting
  • Kansas City, Missouri
    Kansas City, Missouri 64133, United States
    Not yet recruiting
  • Garden City, NY
    Garden City, New York 11530, United States
    Not yet recruiting
  • Salt Lake City, Utah
    Salt Lake City, Utah 84107, United States
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Start is estimated for Oct 2026; primary completion for Aug 2027, 10 months later.

Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Oct 9, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jul 22, 2026
First posted
Jul 27, 2026
StartEst.
Oct 2026was Sep 2026
Primary completionEst.
Aug 2027
CompletionEst.
Feb 2028
Last update
Oct 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 9, 2026
Sites
10 sites added, 1 site removed
Show 10 added (10 United States)
  • Torrance, California · Torrance, United States
  • Largo, Florida · Largo, United States
  • Atlanta, Georgia · Atlanta, United States
  • Chicago, Illinois · Chicago, United States
  • Carmel, Indiana · Carmel, United States
  • Overland Park, Kansas · Overland Park, United States
  • Minnetonka, Minnesota · Minnetonka, United States
  • Kansas City, Missouri · Kansas City, United States
  • Garden City, NY · Garden City, United States
  • Salt Lake City, Utah · Salt Lake City, United States
Show 1 removed
  • Clinical Site 1 · Menlo Park, United States
Oct 9, 2026
Start date
Sep 2026→Oct 2026
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    Not yet recruiting→Recruiting
    10 sites added, 1 site removed
    Show 10 added (10 United States)
    • Torrance, California · Torrance, United States
    • Largo, Florida · Largo, United States
    • Atlanta, Georgia · Atlanta, United States
    • Chicago, Illinois · Chicago, United States
    • Carmel, Indiana · Carmel, United States
    • Overland Park, Kansas · Overland Park, United States
    • Minnetonka, Minnesota · Minnetonka, United States
    • Kansas City, Missouri · Kansas City, United States
    • Garden City, NY · Garden City, United States
    • Salt Lake City, Utah · Salt Lake City, United States
    Show 1 removed
    • Clinical Site 1 · Menlo Park, United States
    Start date Sep 2026→Oct 2026

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07729137
Lead sponsor
Emmecell
Responsible party
Sponsor
First posted
Jul 27, 2026
Start date
Oct 2026 (estimated)
Primary completion
Aug 2027 (estimated)
Completion
Feb 2028 (estimated)
Last update
Oct 9, 2026

Study contacts

Clinical Operations - Emmecell
Contact
clinicaltrials@emmecell.com
650-769-4232
Noelia Kunzevitzky, PhD
study director · Emmecell

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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