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NCT Number: NCT07729137

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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).

Treatment and study plan

150K cells

Biological

Intracameral injection - 150K dose

500K cells

Biological

Intracameral injection - 500K dose

Placebo

Procedure

Intracameral injection of vehicle

Primary outcomes

  1. BCVA

    Time frame: 26 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Operations - Emmecell

CONTACT

[email protected]

650-769-4232

Sponsors and collaborators

Lead sponsor

Emmecell

Industry

Registry information

Official study title

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

Acronym: EMERALD

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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