Health Trials

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

ConditionsCorneal EdemaFuchsFuchs DystrophyFuchs' Endothelial DystrophyEndothelial Corneal DystrophyCorneal Endothelial DecompensationCorneal Endothelial Cell LossCorneal Endothelial DisorderCorneal Endothelial Dystrophy 1Endothelial Cell Loss, CornealPseudophakic Bullous KeratopathyPseudophakic Bullous Keratopathy (PBK)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorEmmecell

About this trial

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.

Eligibility criteria

Qualifiers

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)

Historical CCT increased by ≥ 50 μm OR

Findings of edema by corneal tomography or Anterior Segment Optical Coherence Tomography (AS-OCT).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • 150K cells
  • 500K cells
  • Placebo

Treatment groups

121 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Emmecell

Lead sponsor

Source ClinicalTrials.gov