Study to Assess Safety and Tolerability of Multiple Doses of EO2002

Endothelial Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05636579
• Other study ID #: VSH-003
• Status: Recruiting
• Phase: Phase 1
• Start date: December 1, 2022
• Est. completion date: March 2024

Study information

• Verified date: December 2022
• Source: Asociación para Evitar la Ceguera en México
• Contact: Yara Luna
• Phone: 55 39 53 12 25
• Email: reclutamiento.proyectos[@]apec.com.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: March 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Biological:
• EO2002
Intracameral injection of magnetic human corneal endothelial cells (EO2002)

Drug:
• Ripasudil
Daily use of Ripasudil drops

Locations

Country	Name	City	State
Mexico	Asociacion para Evitar la Ceguera en Mexico	Mexico City	Cdmx

Sponsors (2)

Lead Sponsor	Collaborator
Asociación para Evitar la Ceguera en México	Emmecell

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability of multiple doses of EO2002	Incidence of Treatment-Emergent Adverse Events	32 weeks
Secondary	Central Corneal Thickness	Changes in CCT compared to baseline	32 weeks
Secondary	Best Corrected Visual Acuity	Changes in BCVA compared to baseline	32 weeks