Study of Safety and Tolerability of EO2002 in the Treatment of Corneal Edema
Completed · Phase 1
Conditions studied: Corneal Edema, Corneal Endothelial Dysfunction, Corneal Endothelial Dystrophy, Fuchs Dystrophy, Fuchs Endothelial Corneal Dystrophy, Pseudophakic Bullous Keratopathy, Bullous Keratopathy, Endothelial Dysfunction, Moderate Corneal Endothelial Decompensation
In brief
Corneal edema is the most common indication for corneal transplantation, accounting for approximately 70% of penetrating keratoplasty (PK), and 100% of endothelial keratoplasty (EK) procedures annually. There is currently no disease-modifying treatment for corneal edema. Topical treatments like hypertonic saline are not effective on a long-term basis. For those with advanced disease, where edema and vision loss are not controlled by topical treatment, the only option is a corneal transplant. A potential approach to avoidance of the risks of corneal transplantation is to inject cultured human corneal endothelial cells (HCECs) into the anterior chamber of the eye. This approach may avoid surgery by re-populating the inner most aspect of the cornea with functioning endothelial cells. Emmecell has developed a treatment based on technology integrating biocompatible magnetic nanoparticles with cultured HCECs to treat corneal edema in a minimally invasive way. The primary objective of this phase 1, prospective, multi-center, open-label, dose-escalation study is to evaluate the safety and tolerability of 3 doses of EO2002 with and without endothelial brushing (EB) or Descemet Stripping (DS) in eyes with corneal edema secondary to corneal endothelial dysfunction that qualify for surgery involving full-thickness corneal transplantation or EK.
Key facts
- Study ID
- NCT04894110
- Run by
- Emmecell
- People needed
- 42
- Starts
- 2021-06-22
- Expected to finish
- 2024-10-03
- Last updated by the study team
- 2025-03-05
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All ocular criteria apply to study eye unless otherwise noted.
- Age ≥ 21 years.
- Phakic or Pseudophakic with a posterior chamber intraocular lens
- Symptomatic corneal edema associated with endothelial dysfunction which may be secondary to Fuchs corneal dystrophy or pseudophakic bullous keratopathy.
You may not qualify if…
- All ocular criteria apply to study eye unless otherwise noted.
- Other corneal disease
- Anterior chamber intraocular lens, Sutured or scleral-fixated intraocular lens.
- Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.
- History of refractive surgery.
- Descemet membrane detachment.
- History of uveitis or other ocular inflammatory disease.
- History of incisional glaucoma surgery (e.g.,trabeculectomy, glaucoma drainage implant).
- Intraocular pressure >21 or <7 mm Hg
- Prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty.
- History of ocular neoplasm.
- ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20/200).
- Female who is pregnant, nursing, or planning to become pregnant, or who is of childbearing potential and not using a reliable means of contraception during the study.
- Subject is currently participating in or has participated within the last 3 months in any other clinical trial of an investigational drug by ocular or systemic administration.
- Any concomitant medical or psychological condition that could interfere with study participation or is otherwise not suitable for entry into the study in the opinion of the investigator.
Where it is running
- Los Angeles Location — Greater Los Angeles, California, United States
- San Diego Location — San Diego, California, United States
- Miami Location — Miami, Florida, United States
- Palm Beach Gardens Location — Palm Beach Gardens, Florida, United States
- Atlanta Location — Atlanta, Georgia, United States
- Des Moines Location — Des Moines, Iowa, United States
- Kansas City Location — Overland Park, Kansas, United States
- Grand Rapids Location — Grand Rapids, Michigan, United States
Full record on ClinicalTrials.gov
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