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

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

Study Overview

• Status: Recruiting
• Conditions: Endothelial Dysfunction; Corneal Edema; Fuchs' Endothelial Dystrophy; Fuchs Dystrophy; Corneal Endothelial Dystrophy; Bullous Keratopathy; Pseudophakic Bullous Keratopathy; Corneal Edema Pseudophakic
• Intervention / Treatment: Biological: EO2002; Drug: Ripasudil

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yara Luna; Phone Number: 55 39 53 12 25; Email: reclutamiento.proyectos@apec.com.mx

Study Locations

• Mexico
  • Cdmx
    • Mexico City, Cdmx, Mexico, 04030
      • Recruiting
      • Asociación Para Evitar la Ceguera en México
      • Contact: Yara Luna; Phone Number: 55 39 53 1225; Email: reclutamiento.proyectos@apec.com.mx
      • Principal Investigator: Valeria Sanchez Huerta, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

All ocular criteria apply to the study eye unless otherwise noted.

1. Age ≥ 18 years.
2. Subject is phakic or pseudophakic with a posterior chamber intraocular lens (lens in the bag or sulcus).
3. Symptomatic corneal edema associated with endothelial dysfunction which may be secondary to Fuchs' corneal dystrophy or pseudophakic bullous keratopathy.

Key Exclusion Criteria:

All ocular criteria apply to the study eye unless otherwise noted.

1. Other corneal disease
2. Anterior chamber intraocular lens
3. Sutured or scleral-fixated intraocular lens.
4. Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.
5. History of refractive surgery.
6. History of Vitrectomy
7. Descemet membrane detachment.
8. History of uveitis or other ocular inflammatory disease.
9. History of incisional glaucoma surgery (e.g.,trabeculectomy, glaucoma drainage implant).
10. IOP >21 or <7 mm Hg
11. Prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty.

11. History of ocular neoplasm. 12. ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20/200).

13. 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.

14. 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.

15. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EO2002 with Ripasudil; EO2002 + topical Ripasudil daily, then reinjection at week 6 + topical Ripasudil daily	Biological: EO2002; Intracameral injection of magnetic human corneal endothelial cells (EO2002); Drug: Ripasudil; Daily use of Ripasudil drops
Experimental: EO2002 without Ripasudil; EO2002 injection at Day 0 and re-injection at Week 6	Biological: EO2002; Intracameral injection of magnetic human corneal endothelial cells (EO2002)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability of multiple doses of EO2002	Incidence of Treatment-Emergent Adverse Events	32 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central Corneal Thickness	Changes in CCT compared to baseline	32 weeks
Best Corrected Visual Acuity	Changes in BCVA compared to baseline	32 weeks

Collaborators and Investigators

• Sponsor: Asociación para Evitar la Ceguera en México
• Collaborators: Emmecell
• Investigators: Principal Investigator: Valeria Sanchez Huerta, MD, Asociación para Evitar la Ceguera

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): December 5, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Corneal Diseases; Corneal Dystrophies, Hereditary; Edema; Corneal Edema; Fuchs' Endothelial Dystrophy
• Other Study ID Numbers: VSH-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No