Status:
COMPLETED
Study of Safety and Tolerability of EO2002 in the Treatment of Corneal Edema
Lead Sponsor:
Emmecell
Conditions:
Corneal Edema
Corneal Endothelial Dysfunction
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief 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 annuall...
Detailed Description
The study is designed to occur in 2 groups. The objective with the first group is to preliminarily evaluate the safety of 4 escalating doses. The purpose of the second group is to gather additional sa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04894110
Start Date
June 22 2021
End Date
October 3 2024
Last Update
March 5 2025
Active Locations (8)
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1
Los Angeles Location
Greater Los Angeles, California, United States, 91208
2
San Diego Location
San Diego, California, United States, 92122
3
Miami Location
Miami, Florida, United States, 33136
4
Palm Beach Gardens Location
Palm Beach Gardens, Florida, United States, 33410