Corneal EdemaPhase 2EMERALDNCT07729137
Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
A Phase 2 study testing 150K cells and 500K cells in people with Corneal Edema and Fuchs, run by Emmecell at 10 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Corneal Edema, Fuchs, Fuchs Dystrophy
- What is being tested?
- 150K cells and 500K cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2026to Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- Central corneal thickness ≥ 600 μm and ≤ 1,000 μm, OR Medical Monitor review and approval based on either:
- Historical CCT increased by ≥ 50 μm OR
- Findings of edema by corneal tomography or Anterior Segment Optical Coherence Tomography (AS-OCT).
- Participant is considered a surgical candidate for full-thickness corneal transplantation or endothelial (partial thickness) keratoplasty (EK) consistent with standard-of-care indications.
Who cannot join
- 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.
- Presence of an anterior chamber, sutured, or scleral-fixated intraocular lens.
- Presence of a multifocal or diffractive intraocular lens.
Show all 10Show fewer
- Prior vitrectomy.
- Corneal refractive surgery.
- Descemet dettachment
- 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).
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Not yet recruiting
Atlanta, Georgia
Atlanta, Georgia, 30339
Atlanta, Georgia Location, 650-769-4232, clinicaltrials@emmecell.com
- Recruiting
Carmel, Indiana
Carmel, Indiana, 46032
Carmel, Indiana Location, 650-769-4232, clinicaltrials@emmecell.com
- Not yet recruiting
Chicago, Illinois
Chicago, Illinois, 60612
Chicago, Illinois Location, 650-769-4232, clinicaltrials@emmecell.com
- Not yet recruiting
Garden City, NY
Garden City, New York, 11530
Garden City, NY Location, 650-769-4232, clinicaltrials@emmecell.com
- Not yet recruiting
Kansas City, Missouri
Kansas City, Missouri, 64133
Kansas City, Missouri Location, 650-769-4232, clinicaltrials@emmecell.com
- Not yet recruiting
Largo, Florida
Largo, Florida, 33770
Largo, Florida Location, 650-769-4232, clinicaltrials@emmecell.com
- Not yet recruiting
Minnetonka, Minnesota
Minnetonka, Minnesota, 55305
Minnetonka, Minnesota Location, 650-769-4232, clinicaltrials@emmecell.com
- Not yet recruiting
Overland Park, Kansas
Overland Park, Kansas, 66204
Overland Park, Kansas Location, 650-769-4232, clinicaltrials@emmecell.com
- Not yet recruiting
Salt Lake City, Utah
Salt Lake City, Utah, 84107
Salt Lake City, Utah Location, 650-769-4232, clinicaltrials@emmecell.com
- Not yet recruiting
Torrance, California
Torrance, California, 90505
Torrance, CA Location, 650-769-4232, clinicaltrials@emmecell.com
About this study
Official title: A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 2 Study of EO2002 in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction (EMERALD)
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.
Read the detailed description
This study is designed to evaluate the safety and efficacy of EO2002, an investigational magnetic human corneal endothelial cell (mHCEC) therapy, in adults with corneal edema secondary to corneal endothelial dysfunction. Participants will be randomized to receive a single intracameral injection of one of two doses of EO2002 (150,000 or 500,000 cells) or placebo.
The study will compare the effects of EO2002 on visual acuity and corneal thickness, while also evaluating safety over a 52-week follow-up period. Approximately 105 participants will be treated at multiple sites in the United States.
- Conditions
- Corneal Edema, Fuchs, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy, Endothelial Corneal Dystrophy, Corneal Endothelial Decompensation
- Being tested
- 150K cells, 500K cells, Placebo
- Keywords
- FECD, PBK, Corneal endothelial dysfunction, Fuchs Dystrophy, Fuchs, Corneal edema
- Medical subject headings
- Corneal Edema, Fuchs' Endothelial Dystrophy, Corneal endothelial dystrophy type 2, Corneal Endothelial Cell Loss, Corneal Endothelial Dystrophy 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
150K cellsBiological
Intracameral injection - 150K dose
500K cellsBiological
Intracameral injection - 500K dose
PlaceboProcedure or surgery
Intracameral injection of vehicle
| Study group | Role | What they receive |
|---|---|---|
| 150K cells - EO2002 | Experimental | Intracameral injection of 150K magnetic human corneal endothelial cells Receives: Biological: 150K cells |
| 500K cells - EO2002 | Experimental | Intracameral injection of 500K magnetic human corneal endothelial cells Receives: Biological: 500K cells |
| Placebo | Placebo comparator | Intracameral injection of vehicle (no cells) Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA
Proportion of study eyes achieving ≥ 15-letter best-corrected visual acuity (BCVA) improvement at 26 weeks post-treatment as compared to baseline.
Measured: 26 weeks
Secondary outcomes (4)
BCVA
Mean change in BCVA compared to baseline
Measured: 26 weeks
CCT
Mean change in CCT compared to baseline
Measured: 26 weeks
BCVA
Proportion of subjects achieving ≥10-letter BCVA improvement from baseline
Measured: 26 weeks
BCVA
Proportion of subjects achieving ≥70 letters (ETDRS)
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emmecell
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Noelia Kunzevitzky, PhD, Study director, Emmecell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729137
- Sponsor's protocol ID
- EMME-002
- Acronym
- EMERALD
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 2 Study of EO2002 in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction (EMERALD)
- ClinicalTrials.gov ID
- NCT07729137
- Acronym / sponsor ID
- EMERALD / EMME-002
- Conditions
- Corneal Edema, Fuchs, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy, Endothelial Corneal Dystrophy, Corneal Endothelial Decompensation
- Keywords
- FECD, PBK, Corneal endothelial dysfunction, Fuchs Dystrophy, Fuchs, Corneal edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- EmmecellIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is designed to evaluate the safety and efficacy of EO2002, an investigational magnetic human corneal endothelial cell (mHCEC) therapy, in adults with corneal edema secondary to corneal endothelial dysfunction. Participants will be randomized to receive a single intracameral injection of one of two doses of EO2002 (150,000 or 500,000 cells) or placebo.
The study will compare the effects of EO2002 on visual acuity and corneal thickness, while also evaluating safety over a 52-week follow-up period. Approximately 105 participants will be treated at multiple sites in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 150K cells - EO2002 | Experimental | Biological: 150K cellsIntracameral injection of 150K magnetic human corneal endothelial cells |
| 500K cells - EO2002 | Experimental | Biological: 500K cellsIntracameral injection of 500K magnetic human corneal endothelial cells |
| Placebo | Placebo comparator | Procedure: PlaceboIntracameral injection of vehicle (no cells) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
- Central corneal thickness ≥ 600 μm and ≤ 1,000 μm, OR Medical Monitor review and approval based on either:
- 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 (10 listed)
- 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.
- Presence of an anterior chamber, sutured, or scleral-fixated intraocular lens.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 150K cellsIntracameral injection - 150K dose | Biological | 150K cells - EO2002 |
| 500K cellsIntracameral injection - 500K dose | Biological | 500K cells - EO2002 |
| PlaceboIntracameral injection of vehicle | Procedure or surgery | Placebo |
Primary outcome
BCVA
Time frame: 26 weeks
Proportion of study eyes achieving ≥ 15-letter best-corrected visual acuity (BCVA) improvement at 26 weeks post-treatment as compared to baseline.
4 secondary outcomes
BCVA
Time frame: 26 weeks
CCT
Time frame: 26 weeks
BCVA
Time frame: 26 weeks
BCVA
Time frame: 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Noelia Kunzevitzky, PhD study director
Emmecell
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 150K cells and 500K cells in people with Corneal Edema and Fuchs, run by Emmecell at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Operations - Emmecell (650-769-4232, clinicaltrials@emmecell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCVA (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.