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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 statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 150K cells

    Biological/Vaccine

    Intracameral injection - 150K dose

  • 500K cells

    Biological/Vaccine

    Intracameral injection - 500K dose

  • Placebo

    Procedure/Surgery

    Intracameral injection of vehicle

Treatment groups

121 Participants
are divided into 3 treatment groups
Group A: 150K cells - EO2002Experimental treatment 1 intervention
Group B: 500K cells - EO2002Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
26 weeks

Secondary outcomes

1

BCVA

Mean change in BCVA compared to baseline

Time frame
26 weeks
2

CCT

Mean change in CCT compared to baseline

Time frame
26 weeks
3

BCVA

Proportion of subjects achieving ≥10-letter BCVA improvement from baseline

Time frame
26 weeks
4

BCVA

Proportion of subjects achieving ≥70 letters (ETDRS)

Time frame
26 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emmecell

Lead sponsor

Source ClinicalTrials.gov
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