Study to Assess Safety and Tolerability of EO2002

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05587205
• Other study ID #: VSH-002
• Status: Recruiting
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Cataract
• Corneal Endothelial Cell Loss
• Endothelial Cell Loss, Corneal

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