CataractPhase 1NCT05587205
Safety and Tolerability of EO2002
A Phase 1 study testing EO2002 in people with Cataract and Endothelial Cell Loss, Corneal, 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 intracameral injection of EO2002 in subjects post-cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Endothelial Cell Loss, Corneal
- What is being tested?
- EO2002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteMexico
- Study dates
- 30 Aug 2022to 6 Oct 2026
- 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
- 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
Who cannot join
- All ocular criteria apply to study eye unless otherwise noted.
- 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.
- History of incisional glaucoma surgery
Show all 12Show fewer
- Prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty.
- History of ocular neoplasm.
- ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20/200).
- 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.
- 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.
- 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
About this study
Official title: Phase 1, Randomized, Masked, Sham-Controlled Study to Assess the Safety and Tolerability of EO2002 in Subjects Undergoing Cataract Surgery
The goal of this clinical study is to assess the safety of intracameral injection of EO2002 in subjects post-cataract surgery.
- Conditions
- Cataract, Endothelial Cell Loss, Corneal
- Being tested
- EO2002, Sham injection
- Medical subject headings
- Cataract, Corneal Endothelial Cell Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EO2002Biological
Also called Magnetic Human Corneal Endothelial Cells
Intracameral injection of a single dose of magnetic human corneal endothelial cells (EO2002) either at the time of cataract surgery or post-cataract surgery
Sham injectionOther
Sham injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment at time of surgery | Experimental | EO2002 intracameral injection Receives: Biological: EO2002 |
| Treatment post surgery | Experimental | EO2002 intracameral injection Receives: Biological: EO2002 |
| Treatment at time of or post surgery | Active comparator | EO2002 intracameral injection Receives: Biological: EO2002 |
| Sham injection at time of or post surgery | Sham comparator | Sham injection Receives: Other: Sham injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of EO2002
Incidence of Treatment-Emergent Adverse Events
Measured: 26 weeks
Secondary outcomes (1)
Endothelial Cell Density
Changes in ECD compared to baseline
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start30 Aug 2022
- Primary completion6 Oct 2026 (estimated)
- Study completion6 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 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
- NCT05587205
- Sponsor's protocol ID
- VSH-002
- Status last verified
- Oct 2025
- First submitted
- 17 Oct 2022
- Last updated
- 8 Dec 2025
- Results posted
- 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, Randomized, Masked, Sham-Controlled Study to Assess the Safety and Tolerability of EO2002 in Subjects Undergoing Cataract Surgery
- ClinicalTrials.gov ID
- NCT05587205
- Acronym / sponsor ID
- VSH-002
- Conditions
- Cataract, Endothelial Cell Loss, Corneal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Collaborators
- Emmecell
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 6 Oct 2026 (estimated)
- Study completion
- 6 Oct 2026 (estimated)
- First posted
- 19 Oct 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 intracameral injection of EO2002 in subjects post-cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment at time of surgery | Experimental | Biological: EO2002EO2002 intracameral injection |
| Treatment post surgery | Experimental | Biological: EO2002EO2002 intracameral injection |
| Treatment at time of or post surgery | Active comparator | Biological: EO2002EO2002 intracameral injection |
| Sham injection at time of or post surgery | Sham comparator | Other: Sham injectionSham injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- All ocular criteria apply to study eye unless otherwise noted.
- 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.
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 |
|---|---|---|
| EO2002Also: Magnetic Human Corneal Endothelial CellsIntracameral injection of a single dose of magnetic human corneal endothelial cells (EO2002) either at the time of cataract surgery or post-cataract surgery | Biological | Treatment at time of or post surgery, Treatment at time of surgery, Treatment post surgery |
| Sham injectionSham injection | Other | Sham injection at time of or post surgery |
Primary outcome
Safety and Tolerability of EO2002
Time frame: 26 weeks
Incidence of Treatment-Emergent Adverse Events
1 secondary outcome
Endothelial Cell Density
Time frame: 26 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
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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 in people with Cataract and Endothelial Cell Loss, Corneal, 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 3 inclusion and 12 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. Some participants in this study may receive a placebo. 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 EO2002 (time frame: 26 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.