Recruiting NCT05587205

Safety and Tolerability of EO2002

Phase I Interventional Cataract Endothelial Cell Loss, Corneal

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: EO2002, Sham injection.
Who it may be relevant to: Registry conditions: Cataract, Endothelial Cell Loss, Corneal. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Mexico
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

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

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

Biological EO2002
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 Sham injection
Sham injection

Secondary outcome measures (1)

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Mexico · 1 center

NCT: NCT05587205 · VSH-002