Safety and Tolerability of EO2002

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.

Study Overview

• Status: Recruiting
• Conditions: Cataract; Endothelial Cell Loss, Corneal
• Intervention / Treatment: Biological: EO2002; Other: Sham injection

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yara Luna; Phone Number: 55 39 53 12 25; Email: reclutamiento.proyectos@apec.com.mx

Study Locations

• Mexico
  • Mexico City
    • Mexico City, Mexico City, Mexico, 04030
      • Recruiting
      • Asociación Para Evitar la Ceguera en México
      • Contact: Yara Luna; Phone Number: 55 39 53 1225; Email: reclutamiento.proyectos@apec.com.mx

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment at time of surgery; EO2002 intracameral injection	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 Names: Magnetic Human Corneal Endothelial Cells
Experimental: Treatment post surgery; EO2002 intracameral injection	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 Names: Magnetic Human Corneal Endothelial Cells
Active Comparator: Treatment at time of or post surgery; EO2002 intracameral injection	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 Names: Magnetic Human Corneal Endothelial Cells
Sham Comparator: Sham injection at time of or post surgery; Sham injection	Other: Sham injection; Sham injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability of EO2002	Incidence of Treatment-Emergent Adverse Events	26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial Cell Density	Changes in ECD compared to baseline	26 weeks

Collaborators and Investigators

• Sponsor: Asociación para Evitar la Ceguera en México
• Collaborators: Emmecell
• Investigators: Principal Investigator: Valeria Sanchez Huerta, MD, Asociacion para Evitar la Ceguera

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2022
• Primary Completion (Estimated): October 6, 2026
• Study Completion (Estimated): October 6, 2026

Study Registration Dates

• First Submitted: October 17, 2022
• First Submitted That Met QC Criteria: October 17, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Eye Diseases; Corneal Diseases; Lens Diseases; Eye Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cataract; Corneal Endothelial Cell Loss; salicylhydroxamic acid
• Other Study ID Numbers: VSH-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No