Assessing the safety of EO2002 after cataract surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study evaluates the safety and tolerability of EO2002, administered through an intracameral injection, in patients who have undergone cataract surgery. The trial focuses on individuals with a history of uncomplicated cataracts and decreased endothelial cell counts. Participants will receive either the EO2002 treatment or a sham injection to compare outcomes. The study aims to gather data on the safety profile of EO2002 in this specific patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Asociacion para Evitar la Ceguera en Mexico
  Mexico City, Mexico City, Mexico Recruiting

Study contacts

• Principal investigator: Valeria Sanchez Huerta, MD — Asociacion para Evitar la Ceguera
• Study coordinator: Yara Luna
• Email: reclutamiento.proyectos@apec.com.mx
• Phone: 55 39 53 12 25

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• EO2002 therapy for corneal edema due to endothelial dysfunction

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.