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NCT Number: NCT05636579

Study to Assess Safety and Tolerability of Multiple Doses of EO2002

The goal of this clinical study is to assess the safety of multiple intracameral injections of EO2002 with and without topical Ripasudil.

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

Valeria Sanchez Huerta, MD

PRINCIPAL_INVESTIGATOR

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.

Inclusion criteria

All ocular criteria apply to the study eye unless otherwise noted.

  • Age ≥ 18 years.
  • Subject is phakic or pseudophakic with a posterior chamber intraocular lens (lens in the bag or sulcus).
  • Symptomatic corneal edema associated with endothelial dysfunction which may be secondary to Fuchs' corneal dystrophy or pseudophakic bullous keratopathy.

Key Exclusion Criteria:

All ocular criteria apply to the study eye unless otherwise noted.

  • Other corneal disease
  • Anterior chamber intraocular lens
  • Sutured or scleral-fixated intraocular lens.
  • Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.
  • History of refractive surgery.
  • History of Vitrectomy
  • Descemet membrane detachment.
  • History of uveitis or other ocular inflammatory disease.
  • History of incisional glaucoma surgery (e.g.,trabeculectomy, glaucoma drainage implant).
  • IOP >21 or <7 mm Hg
  • Prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty.
  • History of ocular neoplasm. 12. 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 magnetic human corneal endothelial cells (EO2002)

Ripasudil

Drug

Daily use of Ripasudil drops

Primary outcomes

  1. Safety and Tolerability of multiple doses of EO2002

    Time frame: 32 weeks

    Incidence of Treatment-Emergent Adverse Events

Secondary outcomes

  1. Central Corneal Thickness

    Time frame: 32 weeks

    Changes in CCT compared to baseline

  2. Best Corrected Visual Acuity

    Time frame: 32 weeks

    Changes in BCVA 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, Multiple Dose, Open-Label Study to Assess the Safety and Tolerability of EO2002 Intracameral Injections With or Without Topical Ripasudil in the Treatment of Corneal Edema

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 5, 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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