Corneal EdemaPhase 1NCT05636579
Study to Assess Safety and Tolerability of Multiple Doses of EO2002
A Phase 1 study testing EO2002 and Ripasudil in people with Corneal Edema and Corneal Endothelial Dystrophy, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
Trial summary
The goal of this clinical study is to assess the safety of multiple intracameral injections of EO2002 with and without topical Ripasudil. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Edema, Corneal Endothelial Dystrophy, Endothelial Dysfunction
- What is being tested?
- EO2002 and Ripasudil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteMexico
- Study dates
- 8 Nov 2022to 9 Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All ocular criteria apply to the study eye unless otherwise noted.
- Age ≥ 18 years.
- Subject is phakic or pseudophakic with a posterior chamber intraocular lens (lens in the bag or sulcus).
- Symptomatic corneal edema associated with endothelial dysfunction which may be secondary to Fuchs' corneal dystrophy or pseudophakic bullous keratopathy.
Who cannot join
- All ocular criteria apply to the study eye unless otherwise noted.
- Other corneal disease
- Anterior chamber intraocular lens
- Sutured or scleral-fixated intraocular lens.
- Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.
- History of refractive surgery.
Show all 16Show fewer
- History of Vitrectomy
- Descemet membrane detachment.
- History of uveitis or other ocular inflammatory disease.
- History of incisional glaucoma surgery (e.g.,trabeculectomy, glaucoma drainage implant).
- IOP >21 or <7 mm Hg
- 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 childbearing potential and not using a reliable means of contraception during the study.
- 14. 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Asociacion para Evitar la Ceguera en Mexico
Mexico City, Mexico City, 04030
Yara Luna, 55 39 53 1225, reclutamiento.proyectos@apec.com.mx
Valeria Sanchez Huerta, MD
About this study
Official title: Phase 1, Multiple Dose, Open-Label Study to Assess the Safety and Tolerability of EO2002 Intracameral Injections With or Without Topical Ripasudil in the Treatment of Corneal Edema
The goal of this clinical study is to assess the safety of multiple intracameral injections of EO2002 with and without topical Ripasudil.
- Conditions
- Corneal Edema, Corneal Endothelial Dystrophy, Endothelial Dysfunction, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy, Bullous Keratopathy
- Being tested
- EO2002, Ripasudil
- Medical subject headings
- Corneal Edema, Corneal Dystrophy, Posterior Polymorphous, 1, Fuchs' Endothelial Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EO2002Biological
Intracameral injection of magnetic human corneal endothelial cells (EO2002)
RipasudilDrug
Daily use of Ripasudil drops
| Study group | Role | What they receive |
|---|---|---|
| EO2002 with Ripasudil | Experimental | EO2002 + topical Ripasudil daily, then reinjection at week 6 + topical Ripasudil daily Receives: Biological: EO2002; Drug: Ripasudil |
| EO2002 without Ripasudil | Experimental | EO2002 injection at Day 0 and re-injection at Week 6 Receives: Biological: EO2002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of multiple doses of EO2002
Incidence of Treatment-Emergent Adverse Events
Measured: 32 weeks
Secondary outcomes (2)
Central Corneal Thickness
Changes in CCT compared to baseline
Measured: 32 weeks
Best Corrected Visual Acuity
Changes in BCVA compared to baseline
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start8 Nov 2022
- Primary completion9 Dec 2025 (estimated)
- Study completion9 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asociación para Evitar la Ceguera en México
- Sponsor type
- University, hospital or other
- Collaborators
- Emmecell
- Responsible party
- Sponsor
- Investigators
- Valeria Sanchez Huerta, MD, Principal investigator, Asociacion para Evitar la Ceguera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636579
- Sponsor's protocol ID
- VSH-003
- Status last verified
- Jan 2025
- First submitted
- 8 Nov 2022
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Multiple Dose, Open-Label Study to Assess the Safety and Tolerability of EO2002 Intracameral Injections With or Without Topical Ripasudil in the Treatment of Corneal Edema
- ClinicalTrials.gov ID
- NCT05636579
- Acronym / sponsor ID
- VSH-003
- Conditions
- Corneal Edema, Corneal Endothelial Dystrophy, Endothelial Dysfunction, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy, Bullous Keratopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Collaborators
- Emmecell
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 9 Dec 2025 (estimated)
- Study completion
- 9 Dec 2025 (estimated)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical study is to assess the safety of multiple intracameral injections of EO2002 with and without topical Ripasudil.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EO2002 with Ripasudil | Experimental | Biological: EO2002, Drug: RipasudilEO2002 + topical Ripasudil daily, then reinjection at week 6 + topical Ripasudil daily |
| EO2002 without Ripasudil | Experimental | Biological: EO2002EO2002 injection at Day 0 and re-injection at Week 6 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All ocular criteria apply to the study eye unless otherwise noted.
- Age ≥ 18 years.
- Subject is phakic or pseudophakic with a posterior chamber intraocular lens (lens in the bag or sulcus).
- Symptomatic corneal edema associated with endothelial dysfunction which may be secondary to Fuchs' corneal dystrophy or pseudophakic bullous keratopathy.
Key exclusion criteria (16 listed)
- All ocular criteria apply to the study eye unless otherwise noted.
- Other corneal disease
- Anterior chamber intraocular lens
- Sutured or scleral-fixated intraocular lens.
- Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EO2002Intracameral injection of magnetic human corneal endothelial cells (EO2002) | Biological | EO2002 with Ripasudil, EO2002 without Ripasudil |
| RipasudilDaily use of Ripasudil drops | Drug | EO2002 with Ripasudil |
Primary outcome
Safety and Tolerability of multiple doses of EO2002
Time frame: 32 weeks
Incidence of Treatment-Emergent Adverse Events
2 secondary outcomes
Central Corneal Thickness
Time frame: 32 weeks
Best Corrected Visual Acuity
Time frame: 32 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Corneal Edema
RecruitingPhase 2
Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Corneal Edema, Fuchs
Active, not recruitingPhase 3
AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Corneal Edema, Corneal Endothelial Dysfunction
Active, not recruiting
The Belgian Endothelial Surgical Transplant of the Cornea
Corneal Edema, Corneal Endothelial Disorder
Enrolling by invitationObservational study
The Effect of Topical Rho-kinase Inhibitors on Corneas of Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy, Cataract
Recruiting
Plasma Rich in Growth Factors in Corneal Endothelial Transplantation
Fuchs' Endothelial Dystrophy, Corneal Edema
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valeria Sanchez Huerta, MD principal investigator
Asociacion para Evitar la Ceguera
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EO2002 and Ripasudil in people with Corneal Edema and Corneal Endothelial Dystrophy, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yara Luna (55 39 53 12 25, reclutamiento.proyectos@apec.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of multiple doses of EO2002 (time frame: 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.