Back to resultsA 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 (Escalon)
Primary Purpose
Corneal Edema
Status
Completed
Phase
Phase 1
Locations
El Salvador
Study Type
Interventional
Intervention
HCEC-1
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Edema
Eligibility Criteria
Key Inclusion Criteria:
- 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:
- 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.
Sites / Locations
- Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Low dose Rho kinase inhibitor Y-27632
Mid dose Rho kinase inhibitor Y-27632
High dose Rho kinase inhibitor Y-27632
Arm Description
Low dose Rho kinase inhibitor Y-27632
Mid dose Rho kinase inhibitor Y-27632
High dose Rho kinase inhibitor Y-27632
Outcomes
Primary Outcome Measures
Incidence and severity of Treatment Emergent Ocular Adverse Events (TEAEs)
Incidence and severity of non-ocular TEAEs
Secondary Outcome Measures
Change from baseline in Central Corneal Thickness (CCT) as measured by pachymetry
Change from baseline in Best-Corrected Visual Acuity (BCVA) as measured by LogMAR score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05309135
Brief Title
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
Acronym
Escalon
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 24, 2022 (Actual)
Primary Completion Date
March 9, 2023 (Actual)
Study Completion Date
March 9, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aurion Biotech
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Within the treated groups, the sponsor, investigator, assessor, and subject will be masked to the assigned dose.
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dose Rho kinase inhibitor Y-27632
Arm Type
Active Comparator
Arm Description
Low dose Rho kinase inhibitor Y-27632
Arm Title
Mid dose Rho kinase inhibitor Y-27632
Arm Type
Active Comparator
Arm Description
Mid dose Rho kinase inhibitor Y-27632
Arm Title
High dose Rho kinase inhibitor Y-27632
Arm Type
Active Comparator
Arm Description
High dose Rho kinase inhibitor Y-27632
Intervention Type
Drug
Intervention Name(s)
HCEC-1
Intervention Description
HCEC-1 = human cultured corneal endothelial cells and Rho kinase Y-27632 inhibitor
Primary Outcome Measure Information:
Title
Incidence and severity of Treatment Emergent Ocular Adverse Events (TEAEs)
Time Frame
12 months
Title
Incidence and severity of non-ocular TEAEs
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change from baseline in Central Corneal Thickness (CCT) as measured by pachymetry
Time Frame
12 months
Title
Change from baseline in Best-Corrected Visual Acuity (BCVA) as measured by LogMAR score
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
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:
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.
Facility Information:
Facility Name
Site
City
San Salvador
Country
El Salvador
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The study plan and protocol will be shared with the study center and other researchers per request.
Learn more about this trial
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
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