Study to Assess Safety and Tolerability of Multiple Doses of EO2002

NCT05636579 | Recruiting Phase 1 FDA Drug

• 1 other identifier: VSH-003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of multiple doses of EO2002

  Incidence of Treatment-Emergent Adverse Events

  32 weeks

Secondary Outcomes (2)

• Central Corneal Thickness

  32 weeks

• Best Corrected Visual Acuity

  32 weeks

Study Arms (2)

EO2002 with Ripasudil

EXPERIMENTAL

EO2002 + topical Ripasudil daily, then reinjection at week 6 + topical Ripasudil daily

Biological: EO2002; Drug: Ripasudil

EO2002 without Ripasudil

EXPERIMENTAL

EO2002 injection at Day 0 and re-injection at Week 6

Biological: EO2002

Interventions

EO2002 BIOLOGICAL

Intracameral injection of magnetic human corneal endothelial cells (EO2002)

EO2002 with Ripasudil; EO2002 without Ripasudil

Ripasudil DRUG

Daily use of Ripasudil drops

EO2002 with Ripasudil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asociación para Evitar la Ceguera en México: lead
• Emmecell: collaborator

Study Sites (1)

Asociacion para Evitar la Ceguera en Mexico

Mexico City, Mexico City, 04030, Mexico

RECRUITING

MeSH Terms

Conditions

Corneal Edema; Corneal Dystrophy, Posterior Polymorphous, 1; Fuchs' Endothelial Dystrophy

Interventions

K-115

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Corneal Dystrophies, Hereditary; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Valeria Sanchez Huerta, MD

  Asociacion para Evitar la Ceguera

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yara Luna

CONTACT

55 39 53 12 25; reclutamiento.proyectos@apec.com.mx

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: December 5, 2022
• Study Start: November 8, 2022
• Primary Completion: December 9, 2025
• Study Completion: December 9, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)