Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
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.
Phase
Phase 1
Funding Agency/Sponsor
Industry
Disease
Cornea
Enrollment Eligibility
Inclusion Criteria:
All ocular criteria apply to study eye unless otherwise noted.
1. Age ≥ 21 years.
2. Phakic or Pseudophakic with a posterior chamber intraocular lens
3. Symptomatic corneal edema associated with endothelial dysfunction which may be
secondary to Fuchs corneal dystrophy or pseudophakic bullous keratopathy.
Exclusion Criteria:
All ocular criteria apply to study eye unless otherwise noted.
1. Other corneal disease
2. Anterior chamber intraocular lens, Sutured or scleral-fixated intraocular lens.
3. Macular disease that in the investigator and/or sponsor's opinion would limit the
ability of the subject to demonstrate improvement in BCVA.
4. History of refractive surgery.
5. Descemet membrane detachment.
6. History of uveitis or other ocular inflammatory disease.
7. History of incisional glaucoma surgery (e.g.,trabeculectomy, glaucoma drainage
implant).
8. Intraocular pressure >21 or <7 mm Hg
9. Prior incisional eye surgery within 3 months prior to study treatment or penetrating
or endothelial keratoplasty.
10. History of ocular neoplasm.
11. ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20/200).
12. 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.
13. 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.
14. 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.