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Cell Therapy

EO2002 at different doses for Corneal Edema

Phase 1
Waitlist Available
Research Sponsored by Emmecell
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights

Study Summary

This trial is testing a new treatment for corneal edema that may avoid surgery by injecting cultured human cells into the eye. The primary objective is to evaluate the safety and tolerability of the treatment in eyes with corneal edema.

Who is the study for?
This trial is for adults over 21 with corneal edema due to endothelial dysfunction, often from Fuchs' dystrophy or after cataract surgery. Participants must have symptoms not managed by topical treatments and qualify for corneal transplant surgery. Exclusions include other eye diseases, recent eye surgeries, certain vision impairments in the non-study eye, pregnancy, current participation in another drug trial, and conditions that may affect study results.Check my eligibility
What is being tested?
The study tests EO2002 at different doses as a potential treatment for corneal edema. It's an innovative therapy involving cultured human corneal endothelial cells combined with magnetic nanoparticles injected into the eye to restore function without full surgery. The safety and tolerability of three EO2002 doses will be evaluated alongside two surgical preparation methods.See study design
What are the potential side effects?
As this is a phase 1 trial primarily assessing safety and tolerability, specific side effects are being investigated but may include typical reactions related to ocular injections such as discomfort at the injection site, redness, swelling of the eyes or eyelids, increased tear production or possible visual disturbances.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of EO2002]
Secondary outcome measures
Effect of EO2002 (+/-EB or DS) on best corrected visual acuity (BCVA).
Effect of EO2002 (+/-EB or DS) on corneal thickness

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: EO2002 treatment - Group 1Experimental Treatment1 Intervention
Group II: EO2002 treatment - Group 2 - low doseActive Control1 Intervention
Group III: EO2002 treatment - Group 2 - mid doseActive Control1 Intervention
Group IV: EO2002 treatment - Group 2 - high doseActive Control1 Intervention

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Who is running the clinical trial?

EmmecellLead Sponsor
3 Previous Clinical Trials
79 Total Patients Enrolled
2 Trials studying Corneal Edema
47 Patients Enrolled for Corneal Edema
Noelia KunzevitzkyStudy DirectorEmmecell

Media Library

EO2002 (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04894110 — Phase 1
Corneal Edema Research Study Groups: EO2002 treatment - Group 1, EO2002 treatment - Group 2 - low dose, EO2002 treatment - Group 2 - mid dose, EO2002 treatment - Group 2 - high dose
Corneal Edema Clinical Trial 2023: EO2002 Highlights & Side Effects. Trial Name: NCT04894110 — Phase 1
EO2002 (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04894110 — Phase 1
Corneal Edema Patient Testimony for trial: Trial Name: NCT04894110 — Phase 1
~4 spots leftby Oct 2024
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