[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07729137":3,"trial-entities:NCT07729137":110,"trial-summary:NCT07729137":116},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":31,"study_type":36,"primary_purpose":37,"phases":38,"enrollment_info":40,"interventions":43,"primary_outcomes":60,"secondary_outcomes":65,"sex":75,"minimum_age":76,"maximum_age":77,"healthy_volunteers":78,"eligibility_criteria":79,"std_ages":83,"locations":86,"central_contacts":101,"overall_officials":104,"references":108,"see_also_links":109},"NCT07729137","EMME-002","Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction","A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 2 Study of EO2002 in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction (EMERALD)","NOT_YET_RECRUITING","2028-02","2026-07","2026-07-29","2026-09","Emmecell","INDUSTRY",true,"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.","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.\n\nThe 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.",[19,20,21,22,23,24,25,26,27,28,29,30],"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)",[32,33,34,21,20,35],"FECD","PBK","Corneal endothelial dysfunction","Corneal edema","INTERVENTIONAL","TREATMENT",[39],"PHASE2",{"count":41,"type":42},121,"ESTIMATED",[44,50,55],{"type":45,"name":46,"description":47,"armGroupLabels":48},"BIOLOGICAL","150K cells","Intracameral injection - 150K dose",[49],"150K cells - EO2002",{"type":45,"name":51,"description":52,"armGroupLabels":53},"500K cells","Intracameral injection - 500K dose",[54],"500K cells - EO2002",{"type":56,"name":57,"description":58,"armGroupLabels":59},"PROCEDURE","Placebo","Intracameral injection of vehicle",[57],[61],{"measure":62,"description":63,"timeFrame":64},"BCVA","Proportion of study eyes achieving ≥ 15-letter best-corrected visual acuity (BCVA) improvement at 26 weeks post-treatment as compared to baseline.","26 weeks",[66,68,71,73],{"measure":62,"description":67,"timeFrame":64},"Mean change in BCVA compared to baseline",{"measure":69,"description":70,"timeFrame":64},"CCT","Mean change in CCT compared to baseline",{"measure":62,"description":72,"timeFrame":64},"Proportion of subjects achieving ≥10-letter BCVA improvement from baseline",{"measure":62,"description":74,"timeFrame":64},"Proportion of subjects achieving ≥70 letters (ETDRS)","ALL","21 Years",null,false,{"inclusion":80,"exclusion":81,"raw_text":82},[],[],"Key Inclusion Criteria:\n\n1. 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.\n2. Early Treatment Diabetic Retinopathy Study (ETDRS)-best-corrected distance visual acuity between 20 and 65 letters inclusive (≥ 20 and ≤ 65 letters)\n3. Central corneal thickness ≥ 600 μm and ≤ 1,000 μm, OR Medical Monitor review and approval based on either:\n\n   1. Historical CCT increased by ≥ 50 μm OR\n   2. Findings of edema by corneal tomography or Anterior Segment Optical Coherence Tomography (AS-OCT).\n4. Participant is considered a surgical candidate for full-thickness corneal transplantation or endothelial (partial thickness) keratoplasty (EK) consistent with standard-of-care indications.\n\nKey Exclusion Criteria:\n\n1. 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.\n2. Central corneal scarring from trauma, burns, or infection, or band keratopathy\n3. History of keratoconus or other corneal ectasia (e.g., keratoglobus and pellucid marginal degeneration).\n4. Visually significant cataract, that may limit the participant's ability to demonstrate treatment-related improvement in BCVA.\n5. Presence of an anterior chamber, sutured, or scleral-fixated intraocular lens.\n6. Presence of a multifocal or diffractive intraocular lens.\n7. Prior vitrectomy.\n8. Corneal refractive surgery.\n9. Descemet dettachment\n10. 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).",[84,85],"ADULT","OLDER_ADULT",[87],{"facility":88,"city":89,"state":90,"zip":91,"country":92,"contacts":93,"geoPoint":98},"Clinical Site 1","Menlo Park","California","94025","United States",[94],{"name":88,"role":95,"phone":96,"email":97},"CONTACT","650-769-4232","clinicaltrials@emmecell.com",{"lat":99,"lon":100},37.45383,-122.18219,[102],{"name":103,"role":95,"phone":96,"email":97},"Clinical Operations - Emmecell",[105],{"name":106,"affiliation":13,"role":107},"Noelia Kunzevitzky, PhD","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":111,"biomarkers":115},[19,112,113,114],"Endothelial dysfunction","Fuchs Endothelial Dystrophy","Pseudophakic corneal edema",[],{"nct_id":4,"found":15,"summary":117,"prompt_version":127},{"design":118,"status":119,"heading":120,"summary":121,"follow_up":122,"word_count":123,"commitments":124,"compensation":125,"drugs_mentioned":126},"This study is an interventional trial that will randomly assign participants to receive one of two doses of EO2002 or a placebo. Approximately 121 participants are planned to be enrolled.","completed","Study of EO2002 for Corneal Edema","This study is testing a new treatment called EO2002 for people with corneal edema (swelling of the clear front part of your eye) caused by problems with the corneal endothelium (the inner layer of cells in your cornea). This condition can be due to Fuchs dystrophy or other causes. Researchers want to see if a single injection of EO2002, at one of two different doses, can improve your vision and is safe, compared to a placebo (an inactive injection). You may be able to join if you have symptomatic central corneal edema affecting your vision, and your vision is within a specific range. The study aims to enroll about 121 participants.","Participants will be followed for 52 weeks after treatment.",111,"Participants will receive a single injection and will be followed for 52 weeks to evaluate safety and efficacy.","Not stated in the trial record.",[57],"v2"]