Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Sponsored by Emmecell
About this trial
Last updated 4 months ago
Study ID
Status
Will Be RecruitingType
Phase
Placebo
Accepting
Not accepting
Trial Timing
Planned to start recruiting Sep 2026 · estimated completion Feb 2028
What is this trial about?
What are the Participation Requirements?
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).
