Recruiting
Phase 2

EO2002

Sponsor:

Emmecell

Code:

NCT07729137

Conditions

Corneal Edema

Fuchs

Fuchs Dystrophy

Fuchs' Endothelial Dystrophy

Endothelial Corneal Dystrophy

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

150K cells

500K cells

Placebo

Study Details

Brief 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.

Conditions

Corneal Edema

Fuchs

Fuchs Dystrophy

Fuchs' Endothelial Dystrophy

Endothelial Corneal Dystrophy

Study ID

NCT07729137

Start date

Oct, 2026

Status verified date

Jul, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

121 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 150K cells - EO2002

Intracameral injection of 150K magnetic human corneal endothelial cells

experimental: 500K cells - EO2002

Intracameral injection of 500K magnetic human corneal endothelial cells

placebo comparator: Placebo

Intracameral injection of vehicle (no cells)

Interventions

150K cells

Intracameral injection - 150K dose

500K cells

Intracameral injection - 500K dose

Placebo

Intracameral injection of vehicle

Primary outcome measure

  • BCVA [ Time Frame: 26 weeks ]

Central Contacts and Locations

Central contacts

Clinical Operations - Emmecell

650-769-4232clinicaltrials@emmecell.com

Locations

Carmel, Indiana

Recruiting

Carmel, Indiana, United States, 46032

Contacts

More Information

Sponsor

Emmecell

Last update posted

Oct 9, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Emmecell on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.