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Study to Assess Safety and Tolerability of Multiple Doses of EO2002

Study to Assess Safety and Tolerability of Multiple Doses of EO2002

Recruiting
18 years and older
All
Phase 1

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Overview

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

Eligibility

Inclusion Criteria:

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

  1. Age ≥ 18 years.
  2. Subject is phakic or pseudophakic with a posterior chamber intraocular lens (lens in the bag or sulcus).
  3. 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.

  1. Other corneal disease
  2. Anterior chamber intraocular lens
  3. Sutured or scleral-fixated intraocular lens.
  4. Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.
  5. History of refractive surgery.
  6. History of Vitrectomy
  7. Descemet membrane detachment.
  8. History of uveitis or other ocular inflammatory disease.
  9. History of incisional glaucoma surgery (e.g.,trabeculectomy, glaucoma drainage implant).
  10. IOP >21 or <7 mm Hg
  11. Prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty.
  12. History of ocular neoplasm. 12. ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20/200).
  13. 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.
  14. 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.
  15. 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 details
    Corneal Edema
    Corneal Endothelial Dystrophy
    Endothelial Dysfunction
    Fuchs Dystrophy
    Fuchs' Endothelial Dystrophy
    Bullous Keratopathy
    Pseudophakic Bullous Keratopathy
    Corneal Edema Pseudophakic

NCT05636579

Asociación para Evitar la Ceguera en México

28 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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