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

NCT07729137 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: EMME-002
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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; 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

Outcome Measures

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.

  26 weeks

Secondary Outcomes (4)

• BCVA

  26 weeks

• CCT

  26 weeks

• BCVA

  26 weeks

• BCVA

  26 weeks

Study Arms (3)

150K cells - EO2002

EXPERIMENTAL

Intracameral injection of 150K magnetic human corneal endothelial cells

Biological: 150K cells

500K cells - EO2002

EXPERIMENTAL

Intracameral injection of 500K magnetic human corneal endothelial cells

Biological: 500K cells

Placebo

PLACEBO COMPARATOR

Intracameral injection of vehicle (no cells)

Procedure: Placebo

Interventions

150K cells BIOLOGICAL

Intracameral injection - 150K dose

150K cells - EO2002

500K cells BIOLOGICAL

Intracameral injection - 500K dose

500K cells - EO2002

Placebo PROCEDURE

Intracameral injection of vehicle

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Emmecell: lead

Study Sites (1)

Clinical Site 1

Menlo Park, California, 94025, United States

Location

MeSH Terms

Conditions

Corneal Edema; Fuchs' Endothelial Dystrophy; Corneal endothelial dystrophy type 2; Corneal Endothelial Cell Loss; Corneal Endothelial Dystrophy 1

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Corneal Dystrophies, Hereditary; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Eye Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Noelia Kunzevitzky, PhD

  Emmecell

  STUDY DIRECTOR

Central Study Contacts

Clinical Operations - Emmecell

CONTACT

650-769-4232; clinicaltrials@emmecell.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)