Study to Assess Safety and Tolerability of EO2002
Primary Purpose
Cataract, Endothelial Cell Loss, Corneal
Status
Recruiting
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
EO2002
Sham injection
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility Criteria
Key Inclusion Criteria:
- 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
Exclusion Criteria:
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
- 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.
Sites / Locations
- Asociacion para Evitar la Ceguera en MexicoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Sham Comparator
Arm Label
Treatment at time of surgery
Treatment post surgery
Treatment at time of or post surgery
Sham injection at time of or post surgery
Arm Description
EO2002 intracameral injection
EO2002 intracameral injection
EO2002 intracameral injection
Sham injection
Outcomes
Primary Outcome Measures
Safety and Tolerability of EO2002
Incidence of Treatment-Emergent Adverse Events
Secondary Outcome Measures
Endothelial Cell Density
Changes in ECD compared to baseline
Full Information
NCT ID
NCT05587205
First Posted
October 17, 2022
Last Updated
December 1, 2022
Sponsor
Asociación para Evitar la Ceguera en México
Collaborators
Emmecell
1. Study Identification
Unique Protocol Identification Number
NCT05587205
Brief Title
Study to Assess Safety and Tolerability of EO2002
Official Title
Phase 1, Randomized, Masked, Sham-Controlled Study to Assess the Safety and Tolerability of EO2002 in Subjects Undergoing Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asociación para Evitar la Ceguera en México
Collaborators
Emmecell
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The goal of this clinical study is to assess the safety of intracameral injection of EO2002 in subjects post-cataract surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Endothelial Cell Loss, Corneal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
2 arms are masked as indicated and 2 arms are open label
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment at time of surgery
Arm Type
Experimental
Arm Description
EO2002 intracameral injection
Arm Title
Treatment post surgery
Arm Type
Experimental
Arm Description
EO2002 intracameral injection
Arm Title
Treatment at time of or post surgery
Arm Type
Active Comparator
Arm Description
EO2002 intracameral injection
Arm Title
Sham injection at time of or post surgery
Arm Type
Sham Comparator
Arm Description
Sham injection
Intervention Type
Biological
Intervention Name(s)
EO2002
Other Intervention Name(s)
Magnetic Human Corneal Endothelial Cells
Intervention Description
Intracameral injection of a single dose of magnetic human corneal endothelial cells (EO2002) either at the time of cataract surgery or post-cataract surgery
Intervention Type
Other
Intervention Name(s)
Sham injection
Intervention Description
Sham injection
Primary Outcome Measure Information:
Title
Safety and Tolerability of EO2002
Description
Incidence of Treatment-Emergent Adverse Events
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Endothelial Cell Density
Description
Changes in ECD compared to baseline
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
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
Exclusion Criteria:
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
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yara Luna
Phone
55 39 53 12 25
Email
reclutamiento.proyectos@apec.com.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valeria Sanchez Huerta, MD
Organizational Affiliation
Asociacion para Evitar la Ceguera
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asociacion para Evitar la Ceguera en Mexico
City
Mexico City
State/Province
Cdmx
ZIP/Postal Code
04030
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yara Luna
Phone
55 39 53 1225
Email
reclutamiento.proyectos@apec.com.mx
12. IPD Sharing Statement
Plan to Share IPD
No
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Study to Assess Safety and Tolerability of EO2002
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