Study to Assess Safety and Tolerability of EO2002

Phase 1

Recruiting

• Conditions: Cataract; Endothelial Cell Loss, Corneal
• Interventions: Other: Sham injection; Biological: EO2002

• Registration Number: NCT05587205
• Lead Sponsor: Asociación para Evitar la Ceguera en México

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-30
• Study First Submitted: 2022-10-17
• Study First Submitted QC: 2022-10-17
• Study First Posted: 2022-10-19
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02
• Primary Completion: 2025-07-30
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Sham injection at time of or post surgery	Sham injection	Sham injection
Treatment at time of surgery	EO2002	EO2002 intracameral injection
Treatment at time of or post surgery	EO2002	EO2002 intracameral injection
Treatment post surgery	EO2002	EO2002 intracameral injection

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of EO2002	26 weeks	Incidence of Treatment-Emergent Adverse Events

Secondary Outcome Measures

Name	Time	Method
Endothelial Cell Density	26 weeks	Changes in ECD compared to baseline

Trial Locations

Locations (1)

Asociacion para Evitar la Ceguera en Mexico; 🇲🇽 Mexico City, Cdmx, Mexico