Bullous Keratopathy, Corneal Edema, Corneal Edema Pseudophakic, Corneal Endothelial Dystrophy, Endothelial Dysfunction, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy, Pseudophakic Bullous Keratopathy
Conditions
Brief summary
The goal of this clinical study is to assess the safety of multiple intracameral injections of EO2002 with and without topical Ripasudil.
Interventions
Sponsors
Emmecell
Asociación para Evitar la Ceguera en México
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All ocular criteria apply to the study eye unless otherwise noted. 1. Age ≥ 18 years. 2. Subject is phakic or pseudophakic with a posterior chamber intraocular lens (lens in the bag or sulcus). 3. 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. 1. Other corneal disease 2. Anterior chamber intraocular lens 3. Sutured or scleral-fixated intraocular lens. 4. Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA. 5. History of refractive surgery. 6. History of Vitrectomy 7. Descemet membrane detachment. 8. History of uveitis or other ocular inflammatory disease. 9. History of incisional glaucoma surgery (e.g.,trabeculectomy, glaucoma drainage implant). 10. IOP \>21 or \<7 mm Hg 11. Prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty. 11\. History of ocular neoplasm. 12. ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20/200). 13\. 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. 14\. 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. 15\. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of multiple doses of EO2002 | 32 weeks | Incidence of Treatment-Emergent Adverse Events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central Corneal Thickness | 32 weeks | Changes in CCT compared to baseline |
| Best Corrected Visual Acuity | 32 weeks | Changes in BCVA compared to baseline |
Countries
Mexico
Contacts
Primary ContactYara Luna
Outcome results
None listed