Safety and Tolerability of EO2002

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-30

Study Completion Date

2026-10-06

Brief Summary

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

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Detailed Description

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Conditions

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Cataract Endothelial Cell Loss, Corneal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

2 arms are masked as indicated and 2 arms are open label

Study Groups

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Treatment at time of surgery

EO2002 intracameral injection

Group Type EXPERIMENTAL

EO2002

Intervention Type BIOLOGICAL

Intracameral injection of a single dose of magnetic human corneal endothelial cells (EO2002) either at the time of cataract surgery or post-cataract surgery

Treatment post surgery

EO2002 intracameral injection

Group Type EXPERIMENTAL

EO2002

Intervention Type BIOLOGICAL

Intracameral injection of a single dose of magnetic human corneal endothelial cells (EO2002) either at the time of cataract surgery or post-cataract surgery

Treatment at time of or post surgery

EO2002 intracameral injection

Group Type ACTIVE_COMPARATOR

EO2002

Intervention Type BIOLOGICAL

Intracameral injection of a single dose of magnetic human corneal endothelial cells (EO2002) either at the time of cataract surgery or post-cataract surgery

Sham injection at time of or post surgery

Sham injection

Group Type SHAM_COMPARATOR

Sham injection

Intervention Type OTHER

Sham injection

Interventions

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EO2002

Intracameral injection of a single dose of magnetic human corneal endothelial cells (EO2002) either at the time of cataract surgery or post-cataract surgery

Intervention Type BIOLOGICAL

Sham injection

Intervention Type OTHER

Other Intervention Names

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Magnetic Human Corneal Endothelial Cells

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No