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NCT07729137
Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Conditions: Corneal Edema, Fuchs, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy, Endothelial Corneal Dystrophy, Corneal Endothelial Decompensation, Corneal Endothelial Cell Loss, Corneal Endothelial Disorder, Corneal Endothelial Dystrophy 1, Endothelial Cell Loss, Corneal, Pseudophakic Bullous Keratopathy, Pseudophakic Bullous Keratopathy (PBK)
Sex: All
Ages: 21 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 121
Sponsor: Emmecell
Location: Clinical Site 1 Menlo Park California
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).
Source: ClinicalTrials.gov (NCT07729137). StuddyBuddy aggregates publicly available trial information.