Corneal EdemaPhase 1EscalonNCT05309135
A Safety and Efficacy Study of Corneal Injection for Endothelial Dysfunction Using Human Corneal Endothelial Cell Therapy in Subjects With Corneal Edema Secondary to Endothelial Dysfunction
A Phase 1 study testing HCEC-1 in people with Corneal Edema, run by Aurion Biotech at 1 site in El Salvador.
Trial summary
The purpose of this study is to assess the safety of a fixed dose of human corneal endothelial cells when administered with varying concentrations of Rho kinase inhibitor (Y-27632) in patients with corneal edema secondary to endothelial dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Edema
- What is being tested?
- HCEC-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEl Salvador
- Study dates
- 24 Mar 2022to 9 Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Must have given written informed consent (signed and dated by subject or legal guardian), and any authorizations required by local law and be able to comply with all study requirements
- Clinical diagnosis of corneal edema secondary to endothelial dysfunction
- Best Corrected Visual Acuity (BCVA) no worse than 20/800 ETDRS (1.6 LogMAR) or better than 20/63 (0.5 LogMAR) in the study eye
Who cannot join
- Keratoconus or other conditions of corneal thinning/ectasia
- Progressive stromal or anterior corneal dystrophies
- Pre-operative corneal epithelial, sub-epithelial or stromal staining, scarring or other opacity that is paracentral/central and visually significant, but not suspected to be secondary to corneal endothelial disease with the potential to improve from treatment with HCEC-1
- Prior ophthalmic surgery including cataract surgery except as noted above in Inclusion Criterion #4, corneal transplantation, glaucoma (MIGS, iridectomy, trabeculectomy, valve), or vitreo-retinal surgery, aphakia, anterior chamber-IOL or iris claw IOL, multifocal IOL.
- Relative Afferent Pupillary Defect (RAPD) in the study eye
- Uncontrolled glaucoma or an IOP greater than 24 mmHg that is not controlled with topical beta blockers alone at the time of the Screening Visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-Masked, Randomized, Safety and Efficacy, Single Center Clinical Evaluation of Corneal Injection for Endothelial Dysfunction Using Human Corneal Endothelial Cell Therapy (HCEC-1) in Adult Subjects With Corneal Edema Secondary to Endothelial Dysfunction
The purpose of this study is to assess the safety of a fixed dose of human corneal endothelial cells when administered with varying concentrations of Rho kinase inhibitor (Y-27632) in patients with corneal edema secondary to endothelial dysfunction.
- Conditions
- Corneal Edema
- Being tested
- HCEC-1
- Medical subject headings
- Corneal Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCEC-1Drug
HCEC-1 = human cultured corneal endothelial cells and Rho kinase Y-27632 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Low dose Rho kinase inhibitor Y-27632 | Active comparator | Low dose Rho kinase inhibitor Y-27632 Receives: Drug: HCEC-1 |
| Mid dose Rho kinase inhibitor Y-27632 | Active comparator | Mid dose Rho kinase inhibitor Y-27632 Receives: Drug: HCEC-1 |
| High dose Rho kinase inhibitor Y-27632 | Active comparator | High dose Rho kinase inhibitor Y-27632 Receives: Drug: HCEC-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Treatment Emergent Ocular Adverse Events (TEAEs)
Measured: 12 months
Incidence and severity of non-ocular TEAEs
Measured: 12 months
Secondary outcomes (2)
Change from baseline in Central Corneal Thickness (CCT) as measured by pachymetry
Measured: 12 months
Change from baseline in Best-Corrected Visual Acuity (BCVA) as measured by LogMAR score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start24 Mar 2022
- Primary completion9 Mar 2023
- Study completion9 Mar 2023
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurion Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309135
- Sponsor's protocol ID
- AB-HCEC-1-004
- Acronym
- Escalon
- Status last verified
- Aug 2024
- First submitted
- 16 Mar 2022
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study plan and protocol will be shared with the study center and other researchers per request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Masked, Randomized, Safety and Efficacy, Single Center Clinical Evaluation of Corneal Injection for Endothelial Dysfunction Using Human Corneal Endothelial Cell Therapy (HCEC-1) in Adult Subjects With Corneal Edema Secondary to Endothelial Dysfunction
- ClinicalTrials.gov ID
- NCT05309135
- Acronym / sponsor ID
- Escalon / AB-HCEC-1-004
- Conditions
- Corneal Edema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Aurion BiotechIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 4 Apr 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 purpose of this study is to assess the safety of a fixed dose of human corneal endothelial cells when administered with varying concentrations of Rho kinase inhibitor (Y-27632) in patients with corneal edema secondary to endothelial dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose Rho kinase inhibitor Y-27632 | Active comparator | Drug: HCEC-1Low dose Rho kinase inhibitor Y-27632 |
| Mid dose Rho kinase inhibitor Y-27632 | Active comparator | Drug: HCEC-1Mid dose Rho kinase inhibitor Y-27632 |
| High dose Rho kinase inhibitor Y-27632 | Active comparator | Drug: HCEC-1High dose Rho kinase inhibitor Y-27632 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must have given written informed consent (signed and dated by subject or legal guardian), and any authorizations required by local law and be able to comply with all study requirements
- Clinical diagnosis of corneal edema secondary to endothelial dysfunction
- Best Corrected Visual Acuity (BCVA) no worse than 20/800 ETDRS (1.6 LogMAR) or better than 20/63 (0.5 LogMAR) in the study eye
Key exclusion criteria (6 listed)
- Keratoconus or other conditions of corneal thinning/ectasia
- Progressive stromal or anterior corneal dystrophies
- Pre-operative corneal epithelial, sub-epithelial or stromal staining, scarring or other opacity that is paracentral/central and visually significant, but not suspected to be secondary to corneal endothelial disease with the potential to improve from treatment with HCEC-1
- Prior ophthalmic surgery including cataract surgery except as noted above in Inclusion Criterion #4, corneal transplantation, glaucoma (MIGS, iridectomy, trabeculectomy, valve), or vitreo-retinal surgery, aphakia, anterior chamber-IOL or iris claw IOL, multifocal IOL.
- Relative Afferent Pupillary Defect (RAPD) in the study eye
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 |
|---|---|---|
| HCEC-1HCEC-1 = human cultured corneal endothelial cells and Rho kinase Y-27632 inhibitor | Drug | High dose Rho kinase inhibitor Y-27632, Low dose Rho kinase inhibitor Y-27632, Mid dose Rho kinase inhibitor Y-27632 |
Primary outcome
Incidence and severity of Treatment Emergent Ocular Adverse Events (TEAEs)
Time frame: 12 months
Incidence and severity of non-ocular TEAEs
Time frame: 12 months
2 secondary outcomes
Change from baseline in Central Corneal Thickness (CCT) as measured by pachymetry
Time frame: 12 months
Change from baseline in Best-Corrected Visual Acuity (BCVA) as measured by LogMAR score
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Individual participant dataSharing planned: No. The study plan and protocol will be shared with the study center and other researchers per request.
Related trials for Corneal Edema
RecruitingPhase 2
Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
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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
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Enrolling by invitationObservational study
The Effect of Topical Rho-kinase Inhibitors on Corneas of Patients With Fuchs Endothelial Corneal Dystrophy
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Recruiting
Plasma Rich in Growth Factors in Corneal Endothelial Transplantation
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 HCEC-1 in people with Corneal Edema, run by Aurion Biotech at 1 site in El Salvador.
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 6 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: finished, as of the sponsor's last update on 19 Aug 2024. 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 El Salvador. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of Treatment Emergent Ocular Adverse Events (TEAEs) (time frame: 12 months). The study lists 2 primary outcomes in all. 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 19 Aug 2024.