NCT05587205

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
5mo left

Started Aug 2022

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Aug 2022Oct 2026

Study Start

First participant enrolled

August 30, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2026

Last Updated

December 8, 2025

Status Verified

October 1, 2025

Enrollment Period

4.1 years

First QC Date

October 17, 2022

Last Update Submit

December 2, 2025

Conditions

CataractEndothelial Cell Loss, Corneal

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability of EO2002

    Incidence of Treatment-Emergent Adverse Events

    26 weeks

Secondary Outcomes (1)

  • Endothelial Cell Density

    26 weeks

Study Arms (4)

Treatment at time of surgery

EXPERIMENTAL

EO2002 intracameral injection

Biological: EO2002

Treatment post surgery

EXPERIMENTAL

EO2002 intracameral injection

Biological: EO2002

Treatment at time of or post surgery

ACTIVE COMPARATOR

EO2002 intracameral injection

Biological: EO2002

Sham injection at time of or post surgery

SHAM COMPARATOR

Sham injection

Other: Sham injection

Interventions

Sham injectionOTHER

Sham injection

Sham injection at time of or post surgery
EO2002BIOLOGICAL

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

Also known as: Magnetic Human Corneal Endothelial Cells
Treatment at time of or post surgeryTreatment at time of surgeryTreatment post surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • All ocular criteria apply to study eye unless otherwise noted.
  • Other corneal disease
  • Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.
  • Descemet membrane detachment.
  • History of uveitis or other ocular inflammatory disease.
  • History of incisional glaucoma surgery
  • Prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty.
  • History of ocular neoplasm.
  • ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20/200).
  • 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.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asociacion para Evitar la Ceguera en Mexico

Mexico City, Mexico City, 04030, Mexico

RECRUITING

MeSH Terms

Conditions

CataractCorneal Endothelial Cell Loss

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesCorneal DiseasesEye ManifestationsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Valeria Sanchez Huerta, MD

    Asociacion para Evitar la Ceguera

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yara Luna

CONTACT

55 39 53 12 25reclutamiento.proyectos@apec.com.mx

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
2 arms are masked as indicated and 2 arms are open label
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2022

First Posted

October 19, 2022

Study Start

August 30, 2022

Primary Completion (Estimated)

October 6, 2026

Study Completion (Estimated)

October 6, 2026

Last Updated

December 8, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)