Overview
The goal of this clinical study is to assess the safety of multiple intracameral injections of EO2002 with and without topical Ripasudil.
Eligibility
Inclusion Criteria:
All ocular criteria apply to the study eye unless otherwise noted.
- Age ≥ 18 years.
- Subject is phakic or pseudophakic with a posterior chamber intraocular lens (lens in the bag or sulcus).
- Symptomatic corneal edema associated with endothelial dysfunction which may be secondary to Fuchs' corneal dystrophy or pseudophakic bullous keratopathy.
Key Exclusion Criteria:
All ocular criteria apply to the 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.
- History of Vitrectomy
- Descemet membrane detachment.
- History of uveitis or other ocular inflammatory disease.
- History of incisional glaucoma surgery (e.g.,trabeculectomy, glaucoma drainage implant).
- IOP >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. 12. 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.