Corneal Edema, Corneal Endothelial Cell Loss, Corneal Endothelial Decompensation, Corneal Endothelial Disorder, Corneal Endothelial Dystrophy 1, Endothelial Cell Loss, Corneal, Endothelial Corneal Dystrophy, Fuchs, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy, Pseudophakic Bullous Keratopathy, Pseudophakic Bullous Keratopathy (PBK)
Conditions
Keywords
FECD, PBK, Corneal endothelial dysfunction, Fuchs Dystrophy, Fuchs, Corneal edema
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.
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.
Interventions
BIOLOGICAL150K cells
Intracameral injection - 150K dose
BIOLOGICAL500K cells
Intracameral injection - 500K dose
PROCEDUREPlacebo
Intracameral injection of vehicle
Sponsors
Emmecell
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BCVA | 26 weeks | Proportion of study eyes achieving ≥ 15-letter best-corrected visual acuity (BCVA) improvement at 26 weeks post-treatment as compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BCVA | 26 weeks | Mean change in BCVA compared to baseline |
| CCT | 26 weeks | Mean change in CCT compared to baseline |
Countries
United States
Contacts
CONTACTClinical Operations - Emmecell
STUDY_DIRECTORNoelia Kunzevitzky, PhD
Emmecell
Outcome results
None listed