Safety and Tolerability of EO2002
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAsociación para Evitar la Ceguera en México
About this trial
The goal of this clinical study is to assess the safety of intracameral injection of EO2002 in subjects post-cataract surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
EO2002
Biological/VaccineIntracameral 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
Other interventionSham injection
Treatment groups
32 Participants
are divided into 4 treatment groupsGroup A: Treatment at time of surgeryExperimental treatment 1 intervention
Group B: Treatment post surgeryExperimental treatment 1 intervention
Group C: Treatment at time of or post surgeryActive comparator 1 intervention
Group D: Sham injection at time of or post surgerySham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Safety and Tolerability of EO2002
Incidence of Treatment-Emergent Adverse Events
Time frame
26 weeksSecondary outcomes
1
Endothelial Cell Density
Changes in ECD compared to baseline
Time frame
26 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Asociación para Evitar la Ceguera en México
Lead sponsor
Emmecell
Collaborator
Source ClinicalTrials.gov