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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05587205
Other study ID # VSH-002
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date December 1, 2022
Est. completion date June 1, 2024

Study information

Verified date October 2022
Source Asociación para Evitar la Ceguera en México
Contact Yara Luna
Phone 55 39 53 12 25
Email reclutamiento.proyectos@apec.com.mx
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical study is to assess the safety of intracameral injection of EO2002 in subjects post-cataract surgery.


Recruitment information / eligibility

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.

Study Design


Intervention

Biological:
EO2002
Intracameral injection of a single dose of magnetic human corneal endothelial cells (EO2002) either at the time of cataract surgery or post-cataract surgery
Other:
Sham injection
Sham injection

Locations

Country Name City State
Mexico Asociacion para Evitar la Ceguera en Mexico Mexico City Cdmx

Sponsors (2)

Lead Sponsor Collaborator
Asociación para Evitar la Ceguera en México Emmecell

Country where clinical trial is conducted

Mexico, 

Outcome

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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