Study to Assess Safety and Tolerability of Multiple Doses of EO2002

Phase 1

Recruiting

• Conditions: Pseudophakic Bullous Keratopathy; Corneal Edema; Corneal Endothelial Dystrophy; Fuchs Dystrophy; Fuchs' Endothelial Dystrophy; Endothelial Dysfunction; Bullous Keratopathy; Corneal Edema Pseudophakic
• Interventions: Biological: EO2002; Drug: Ripasudil

• Registration Number: NCT05636579
• Lead Sponsor: Asociación para Evitar la Ceguera en México

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-08
• Study First Submitted: 2022-11-08
• Study First Submitted QC: 2022-12-01
• Study First Posted: 2022-12-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02
• Primary Completion: 2025-07-30
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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.

12. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EO2002 with Ripasudil	Ripasudil	EO2002 + topical Ripasudil daily, then reinjection at week 6 + topical Ripasudil daily
EO2002 with Ripasudil	EO2002	EO2002 + topical Ripasudil daily, then reinjection at week 6 + topical Ripasudil daily
EO2002 without Ripasudil	EO2002	EO2002 injection at Day 0 and re-injection at Week 6

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of multiple doses of EO2002	32 weeks	Incidence of Treatment-Emergent Adverse Events

Secondary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity	32 weeks	Changes in BCVA compared to baseline
Central Corneal Thickness	32 weeks	Changes in CCT compared to baseline

Trial Locations

Locations (1)

Asociacion para Evitar la Ceguera en Mexico; 🇲🇽 Mexico City, Cdmx, Mexico