RecruitingPhase 1NCT05636579

Study to Assess Safety and Tolerability of Multiple Doses of EO2002

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


Sponsor

Asociación para Evitar la Ceguera en México

Enrollment

12 participants

Start Date

Nov 8, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests the safety and tolerability of multiple doses of EO2002, a new eye drop treatment for corneal edema (swelling of the clear front part of the eye) caused by endothelial dysfunction — a condition where the inner layer of the cornea fails to pump out excess fluid. This can occur due to Fuchs' corneal dystrophy or as a complication after cataract surgery. You may be eligible if... - You are 18 or older - You have symptomatic corneal swelling due to Fuchs' dystrophy or pseudophakic bullous keratopathy - You have a lens implant (either natural or artificial in the posterior chamber) You may NOT be eligible if... - You have had refractive eye surgery (LASIK, PRK, etc.) or vitrectomy - You have other corneal disease, glaucoma drainage surgery, or a history of uveitis - You have had eye surgery within 3 months of the study - You are pregnant, nursing, or planning to become pregnant - You have macular disease that would limit the ability to measure vision improvement Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALEO2002

Intracameral injection of magnetic human corneal endothelial cells (EO2002)

DRUGRipasudil

Daily use of Ripasudil drops


Locations(1)

Asociacion para Evitar la Ceguera en Mexico

Mexico City, Mexico City, Mexico

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NCT05636579


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