Cataract, Endothelial Cell Loss, Corneal
Conditions
Brief summary
The goal of this clinical study is to assess the safety of intracameral injection of EO2002 in subjects post-cataract surgery.
Interventions
BIOLOGICALEO2002
Intracameral injection of a single dose of magnetic human corneal endothelial cells (EO2002) either at the time of cataract surgery or post-cataract surgery
OTHERSham injection
Sham injection
Sponsors
Emmecell
Asociación para Evitar la Ceguera en México
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
2 arms are masked as indicated and 2 arms are open label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Age ≥ 18 years. 2. Subject has uncomplicated history of cataract that has progressed to a level requiring standard cataract extraction with intraocular lens implant surgery. 3. Decreased endothelial cell count
Exclusion criteria
All ocular criteria apply to study eye unless otherwise noted. 1. Other corneal disease 2. Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA. 3. Descemet membrane detachment. 4. History of uveitis or other ocular inflammatory disease. 5. History of incisional glaucoma surgery 6. Prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty. 7. History of ocular neoplasm. 8. ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20/200). 9. 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. 10. 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. 11. 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 EO2002 | 26 weeks | Incidence of Treatment-Emergent Adverse Events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial Cell Density | 26 weeks | Changes in ECD compared to baseline |
Countries
Mexico
Contacts
Primary ContactYara Luna
Outcome results
None listed