Trials Sponsors Conditions Drugs Pricing

Conditions

Cataract Endothelial 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

Interventions

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

Sham injectionOther

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.

Sponsors & Collaborators

Emmecell
Industrycollaborator
Asociación para Evitar la Ceguera en México
Otherlead

Study Sites (1)

Asociacion para Evitar la Ceguera en Mexico

Mexico City, Mexico City, 04030, Mexico

RECRUITING

Yara LunaCONTACT55 39 53 1225 reclutamiento.proyectos@apec.com.mx

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 25 reclutamiento.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

Actual (reported)

Primary Completion

October 6, 2026

Estimated (date passed)

Safety and Tolerability of EO2002

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (4)

Treatment at time of surgery

Treatment post surgery

Treatment at time of or post surgery

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Sham injection at time of or post surgery

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (4)

Treatment at time of surgery

Treatment post surgery

Treatment at time of or post surgery

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Sham injection at time of or post surgery

You may not qualify if:

Data Sharing

Source record

Locations