NCT07729137 Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
| NCT ID | NCT07729137 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Emmecell |
| Condition | Corneal Edema |
| Study Type | INTERVENTIONAL |
| Enrollment | 121 participants |
| Start Date | 2026-10 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 121 participants in total. It began in 2026-10 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Key Inclusion Criteria: 1. 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. 2. Early Treatment Diabetic Retinopathy Study (ETDRS)-best-corrected distance visual acuity between 20 and 65 letters inclusive (≥ 20 and ≤ 65 letters) 3. Central corneal thickness ≥ 600 μm and ≤ 1,000 μm, OR Medical Monitor review and approval based on either: 1. Historical CCT increased by ≥ 50 μm OR 2. Findings of edema by corneal tomography or Anterior Segment Optical Coherence Tomography (AS-OCT). 4. 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: 1. 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. 2. Central corneal scarring from trauma, burns, or infection, or band keratopathy 3. History of keratoconus or other corneal ectasia (e.g., keratoglobus and pellucid marginal degeneration). 4. Visually significant cataract, that may limit the participant's ability to demonstrate treatment-related improvement in BCVA. 5. Presence of an anterior chamber, sutured, or scleral-fixated intraocular lens. 6. Presence of a multifocal or diffractive intraocular lens. 7. Prior vitrectomy. 8. Corneal refractive surgery. 9. Descemet dettachment 10. 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).
Contact & Investigator
Noelia Kunzevitzky, PhD
STUDY DIRECTOR
Emmecell
Frequently Asked Questions
Who can join the NCT07729137 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Corneal Edema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07729137 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07729137 currently recruiting?
Yes, NCT07729137 is actively recruiting participants. Contact the research team at clinicaltrials@emmecell.com for enrollment information.
Where is the NCT07729137 trial being conducted?
This trial is being conducted at Torrance, United States, Largo, United States, Atlanta, United States, Chicago, United States and 6 additional locations.
Who is sponsoring the NCT07729137 clinical trial?
NCT07729137 is sponsored by Emmecell. The principal investigator is Noelia Kunzevitzky, PhD at Emmecell. The trial plans to enroll 121 participants.