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Cell Therapy
EO2002 at different doses for Corneal Edema
Phase 1
Recruiting
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 26 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
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
Find a Location
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a detached layer in my eye's cornea.I have had surgery for glaucoma.I have not had eye surgery in the last 3 months.I have a disease affecting my cornea.I have had surgery to correct my vision.I have had uveitis or another eye inflammation before.I have had eye cancer in the past.My eye condition may prevent me from showing improvement in vision tests.I am 21 years old or older.I have swelling in my eye's cornea due to a condition like Fuchs dystrophy.I am not pregnant, nursing, or planning to become pregnant and I use reliable contraception.
Research Study Groups:
This trial has the following groups:- Group 1: EO2002 treatment - Group 1
- Group 2: EO2002 treatment - Group 2 - low dose
- Group 3: EO2002 treatment - Group 2 - mid dose
- Group 4: EO2002 treatment - Group 2 - high dose
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Corneal Edema Patient Testimony for trial: Trial Name: NCT04894110 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA granted authorization for EO2002?
"The safety profile of EO2002 is ranked at 1 on our scale, indicating that there is limited evidence supporting its efficacy and minimal data available to verify the drug's safety."
Answered by AI
How many participants are being accepted for this medical trial?
"This medical trial necessitates the participation of 21 eligible patients, who can join from either San Diego Location in California or Miami Location in Florida."
Answered by AI
What is the geographical breadth of this trial's operations?
"This study is currently accepting participants at 7 different sites, including San Diego Location in California, Miami Location in Florida, and Des Moines Location in Iowa. There are also an additional 4 locations participating."
Answered by AI
Are there any openings left to participate in this clinical inquiry?
"Affirmative. The information on clinicaltrials.gov states that this scientific experiment is actively looking for participants, and was first posted June 22nd 2021 with the most recent update happening September 1st 2022. In total, 21 patients will be sourced from 7 different locations."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
San Diego Location
Atlanta Location
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
0
Why did patients apply to this trial?
I have Fuchs Dystrophy and my near vision is continually diminishing. I would like to slow the progression.
PatientReceived 2+ prior treatments
I'm interested in this study because medication alone hasn't resolved my cornela edema and my doctor has begun discussing the option of partial thickness cornea transplant, which I'd rather not do unless absolutely necessary.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long is the trial? Is it a paid trial?
PatientReceived 2+ prior treatments
How responsive is this trial?
Most responsive sites:
- Atlanta Location: < 48 hours
Typically responds via
Phone Call
Average response time
- < 2 Days
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