EO2002 therapy for corneal edema due to endothelial dysfunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, randomized, placebo-controlled study to evaluate the safety and effectiveness of two EO2002 dose levels (150,000 or 500,000 mHCECs) given as a single eye injection. Participants with corneal edema from endothelial dysfunction, such as Fuchs dystrophy, are assigned to one of the two EO2002 doses or placebo and followed for 52 weeks. Outcomes include changes in visual acuity and central corneal thickness, along with safety assessments. Approximately 105 participants will be enrolled at multiple US sites.

Why it matters

Who can join: the full rules

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).

Where it's running

• Carmel, Indiana
  Carmel, Indiana, United States Recruiting
• Torrance, California
  Torrance, California, United States Not yet recruiting
• Largo, Florida
  Largo, Florida, United States Not yet recruiting
• Atlanta, Georgia
  Atlanta, Georgia, United States Not yet recruiting
• Chicago, Illinois
  Chicago, Illinois, United States Not yet recruiting
• Overland Park, Kansas
  Overland Park, Kansas, United States Not yet recruiting

Study contacts

• Study coordinator: Clinical Operations - Emmecell
• Email: clinicaltrials@emmecell.com
• Phone: 650-769-4232

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using OCT to assess corneal health in Fuchs' Dystrophy

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.