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

Endothelial Dysfunction Pseudophakic Bullous Keratopathy Fuchs' Endothelial Dystrophy Corneal Edema Fuchs Dystrophy Bullous Keratopathy Corneal Endothelial Dystrophy Corneal Edema Pseudophakic

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

Inclusion Criteria4

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.

Exclusion Criteria16

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.