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Study to Assess Safety and Tolerability of Multiple Doses of EO2002

Primary Purpose

Corneal Edema, Corneal Endothelial Dystrophy, Endothelial Dysfunction

Status
Recruiting
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
EO2002
Ripasudil
Sponsored by
Asociación para Evitar la Ceguera en México
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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: 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. 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.

Sites / Locations

  • Asociacion para Evitar la Ceguera en MexicoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

EO2002 with Ripasudil

EO2002 without Ripasudil

Arm Description

EO2002 + topical Ripasudil daily, then reinjection at week 6 + topical Ripasudil daily

EO2002 injection at Day 0 and re-injection at Week 6

Outcomes

Primary Outcome Measures

Safety and Tolerability of multiple doses of EO2002
Incidence of Treatment-Emergent Adverse Events

Secondary Outcome Measures

Central Corneal Thickness
Changes in CCT compared to baseline
Best Corrected Visual Acuity
Changes in BCVA compared to baseline

Full Information

First Posted
November 8, 2022
Last Updated
December 1, 2022
Sponsor
Asociación para Evitar la Ceguera en México
Collaborators
Emmecell
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1. Study Identification

Unique Protocol Identification Number
NCT05636579
Brief Title
Study to Assess Safety and Tolerability of Multiple Doses of EO2002
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
March 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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical study is to assess the safety of multiple intracameral injections of EO2002 with and without topical Ripasudil.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Edema, Corneal Endothelial Dystrophy, Endothelial Dysfunction, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy, Bullous Keratopathy, Pseudophakic Bullous Keratopathy, Corneal Edema Pseudophakic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EO2002 with Ripasudil
Arm Type
Experimental
Arm Description
EO2002 + topical Ripasudil daily, then reinjection at week 6 + topical Ripasudil daily
Arm Title
EO2002 without Ripasudil
Arm Type
Experimental
Arm Description
EO2002 injection at Day 0 and re-injection at Week 6
Intervention Type
Biological
Intervention Name(s)
EO2002
Intervention Description
Intracameral injection of magnetic human corneal endothelial cells (EO2002)
Intervention Type
Drug
Intervention Name(s)
Ripasudil
Intervention Description
Daily use of Ripasudil drops
Primary Outcome Measure Information:
Title
Safety and Tolerability of multiple doses of EO2002
Description
Incidence of Treatment-Emergent Adverse Events
Time Frame
32 weeks
Secondary Outcome Measure Information:
Title
Central Corneal Thickness
Description
Changes in CCT compared to baseline
Time Frame
32 weeks
Title
Best Corrected Visual Acuity
Description
Changes in BCVA compared to baseline
Time Frame
32 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: 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. 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.
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
First Name & Middle Initial & Last Name & Degree
Valeria Sanchez Huerta, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study to Assess Safety and Tolerability of Multiple Doses of EO2002

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