Study to Assess Safety and Tolerability of Multiple Doses of EO2002

Asociación para Evitar la Ceguera en México

Status and phase: Enrolling; Phase 1

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

Treatments: Biological: EO2002; Drug: Ripasudil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05636579

VSH-003

Details and patient eligibility

About

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

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

EO2002 with Ripasudil

Experimental group

Description:

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

Treatment:

Drug: Ripasudil

Biological: EO2002

EO2002 without Ripasudil

Experimental group

Description:

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

Treatment:

Biological: EO2002