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Recruiting

NCT Number: NCT05587205

Safety and Tolerability of EO2002

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Asociacion para Evitar la Ceguera en Mexico

Mexico City, 04030, Mexico

Location status: Recruiting

Location contact

Yara Luna

CONTACT

[email protected]

55 39 53 1225

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Age ≥ 18 years.
  • Subject has uncomplicated history of cataract that has progressed to a level requiring standard cataract extraction with intraocular lens implant surgery.
  • Decreased endothelial cell count

Exclusion criteria

All ocular criteria apply to study eye unless otherwise noted.

  • Other corneal disease
  • Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.
  • Descemet membrane detachment.
  • History of uveitis or other ocular inflammatory disease.
  • History of incisional glaucoma surgery
  • Prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty.
  • History of ocular neoplasm.
  • ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20/200).
  • 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.
  • 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.
  • 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.

Treatment and study plan

EO2002

Biological

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 Injection

Other

Sham injection

Primary outcomes

  1. Safety and Tolerability of EO2002

    Time frame: 26 weeks

    Incidence of Treatment-Emergent Adverse Events

Secondary outcomes

  1. Endothelial Cell Density

    Time frame: 26 weeks

    Changes in ECD compared to baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Asociación para Evitar la Ceguera en México

Other

Collaborators

  • Emmecell

Registry information

Official study title

Phase 1, Randomized, Masked, Sham-Controlled Study to Assess the Safety and Tolerability of EO2002 in Subjects Undergoing Cataract Surgery

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 19, 2022
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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