Cataract Clinical Trial
Official title:
Phase 1, Randomized, Masked, Sham-Controlled Study to Assess the Safety and Tolerability of EO2002 in Subjects Undergoing Cataract Surgery
The goal of this clinical study is to assess the safety of intracameral injection of EO2002 in subjects post-cataract surgery.
Status | Recruiting |
Enrollment | 32 |
Est. completion date | June 1, 2024 |
Est. primary completion date | November 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Mexico | Asociacion para Evitar la Ceguera en Mexico | Mexico City | Cdmx |
Lead Sponsor | Collaborator |
---|---|
Asociación para Evitar la Ceguera en México | Emmecell |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and Tolerability of EO2002 | Incidence of Treatment-Emergent Adverse Events | 26 weeks | |
Secondary | Endothelial Cell Density | Changes in ECD compared to baseline | 26 weeks |
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