ClinicalTrials.gg
RecruitingNCT05636579Updated Dec 8, 2025

Study to Assess Safety and Tolerability of Multiple Doses of EO2002

A Phase 1 interventional study of EO2002 and Ripasudil in Corneal Edema, Corneal Endothelial Dystrophy and Endothelial Dysfunction, 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

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Nov 2022; still recruiting 4 years later.
Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this clinical study is to assess the safety of multiple intracameral injections of EO2002 with and without topical Ripasudil.

02

Conditions studied

  • Corneal Edema
  • Corneal Endothelial Dystrophy
  • Endothelial Dysfunction
  • Fuchs Dystrophy
  • Fuchs' Endothelial Dystrophy
  • Bullous Keratopathy
  • Pseudophakic Bullous Keratopathy
  • Corneal Edema Pseudophakic
03

In context

Corneal Edema

39 studies on the registry are indexed under Corneal Edema; 8 are open to participants now.

This study's planned enrollment of 12 is below the median of 52 across 31 interventional studies indexed under Corneal Edema.

Browse Corneal Edema studies →

Lead sponsor

Asociación para Evitar la Ceguera en México is the lead sponsor of 60 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Eligibility criteria

Inclusion Criteria:

All ocular criteria apply to the study eye unless otherwise noted.

  1. Age ≥ 18 years.
  2. Subject is phakic or pseudophakic with a posterior chamber intraocular lens (lens in the bag or sulcus).
  3. Symptomatic corneal edema associated with endothelial dysfunction which may be secondary to Fuchs' corneal dystrophy or pseudophakic bullous keratopathy.

Key Exclusion Criteria:

All ocular criteria apply to the study eye unless otherwise noted.

  1. Other corneal disease
  2. Anterior chamber intraocular lens
  3. Sutured or scleral-fixated intraocular lens.
  4. Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.
  5. History of refractive surgery.
  6. History of Vitrectomy
  7. Descemet membrane detachment.
  8. History of uveitis or other ocular inflammatory disease.
  9. History of incisional glaucoma surgery (e.g.,trabeculectomy, glaucoma drainage implant).
  10. IOP >21 or \<7 mm Hg
  11. Prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty.

11. History of ocular neoplasm. 12. ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20/200).

13. Female who is pregnant, nursing, or planning to become pregnant, or who is of and not using a reliable means of during the study.

14. Subject is currently participating in or has participated within the last 3 months in any other clinical trial of an drug by ocular or systemic administration.

15. 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.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    EO2002 with Ripasudil

    EO2002 + topical Ripasudil daily, then reinjection at week 6 + topical Ripasudil daily

    Biological: EO2002 · Drug: Ripasudil

  • Experimental
    EO2002 without Ripasudil

    EO2002 injection at Day 0 and re-injection at Week 6

    Biological: EO2002

Interventions

  • BiologicalEO2002

    Intracameral injection of magnetic human corneal endothelial cells (EO2002)

  • Daily use of Ripasudil drops

06

What researchers measure

Primary outcomes

  1. Safety and Tolerability of multiple doses of EO2002

    Incidence of Treatment-Emergent Adverse Events

    Time frame: 32 weeks

Secondary outcomes

  1. Central Corneal Thickness

    Changes in CCT compared to baseline

    Time frame: 32 weeks

  2. Best Corrected Visual Acuity

    Changes in BCVA compared to baseline

    Time frame: 32 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05636579
Lead sponsor
Asociación para Evitar la Ceguera en México
Collaborators
Emmecell
Responsible party
Sponsor
First posted
Dec 5, 2022
Start date
Nov 8, 2022
Primary completion
Dec 9, 2025 (estimated)
Completion
Dec 9, 2025 (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

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

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