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

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)

Overview

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.

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.

Interventions

• Biological 150K cells
  Intracameral injection - 150K dose
• Biological 500K cells
  Intracameral injection - 500K dose
• Procedure Placebo
  Intracameral injection of vehicle

Primary outcome measures

• BCVA [Time frame: 26 weeks]

Secondary outcome measures (4)

• BCVA [Time frame: 26 weeks]
• CCT [Time frame: 26 weeks]
• BCVA [Time frame: 26 weeks]
• BCVA [Time frame: 26 weeks]

Eligibility criteria

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.

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Clinical Site 1 — Menlo Park

Identifiers

NCT: NCT07729137 · EMME-002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗