CClinicalTrials.gg
RecruitingNCT05587205Updated Dec 8, 2025

Safety and Tolerability of EO2002

A Phase 1 interventional study of EO2002 and Sham injection in Cataract and Endothelial Cell Loss, Corneal, sponsored by Asociación para Evitar la Ceguera en México. Recruiting at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-08.

Sponsored by Asociación para Evitar la Ceguera en México · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Cataract
  • Endothelial Cell Loss, Corneal
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    Treatment at time of surgery

    EO2002 intracameral injection

    Biological: EO2002

  • Experimental
    Treatment post surgery

    EO2002 intracameral injection

    Biological: EO2002

  • Active comparator
    Treatment at time of or post surgery

    EO2002 intracameral injection

    Biological: EO2002

  • Sham comparator
    Sham injection at time of or post surgery

    Sham injection

    Other: Sham injection

Interventions

  • BiologicalEO2002

    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

  • OtherSham injection

    Sham injection

05

What researchers measure

Primary outcomes

  1. Safety and Tolerability of EO2002

    Incidence of Treatment-Emergent Adverse Events

    Time frame: 26 weeks

Secondary outcomes

  1. Endothelial Cell Density

    Changes in ECD compared to baseline

    Time frame: 26 weeks

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05587205
Lead sponsor
Asociación para Evitar la Ceguera en México
Collaborators
Emmecell
Responsible party
Sponsor
First posted
Oct 19, 2022
Start date
Aug 30, 2022
Primary completion
Oct 6, 2026 (estimated)
Completion
Oct 6, 2026 (estimated)
Last update
Dec 8, 2025

Study contacts

Yara Luna
Contact
reclutamiento.proyectos@apec.com.mx
55 39 53 12 25
Valeria Sanchez Huerta, MD
principal investigator · Asociacion para Evitar la Ceguera

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion