Safety and Tolerability of EO2002

Asociación para Evitar la Ceguera en México

Status and phase: Enrolling; Phase 1

Conditions: Cataract; Endothelial Cell Loss, Corneal

Treatments: Other: Sham injection; Biological: EO2002

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05587205

VSH-002

Details and patient eligibility

About

The goal of this clinical study is to assess the safety of intracameral injection of EO2002 in subjects post-cataract surgery.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Age ≥ 18 years.
2. Subject has uncomplicated history of cataract that has progressed to a level requiring standard cataract extraction with intraocular lens implant surgery.
3. Decreased endothelial cell count

Exclusion Criteria:

All ocular criteria apply to study eye unless otherwise noted.

1. Other corneal disease
2. Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.
3. Descemet membrane detachment.
4. History of uveitis or other ocular inflammatory disease.
5. History of incisional glaucoma surgery
6. Prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty.
7. History of ocular neoplasm.
8. ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20/200).
9. 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.
10. 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.
11. 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: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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32 participants in 4 patient groups

Treatment at time of surgery

Experimental group

Description:

EO2002 intracameral injection

Treatment:

Biological: EO2002

Treatment post surgery

Experimental group

Description:

EO2002 intracameral injection

Treatment:

Biological: EO2002

Treatment at time of or post surgery

Active Comparator group

Description:

EO2002 intracameral injection

Treatment:

Biological: EO2002

Sham injection at time of or post surgery

Sham Comparator group

Description:

Sham injection

Treatment:

Other: Sham injection