Clincosm LogoSign in Get a demo

Study to Assess Safety and Tolerability of EO2002

Sponsor
Asociación para Evitar la Ceguera en México (Other)
Overall Status
Recruiting
CT.gov ID
NCT05587205
Collaborator
Emmecell (Industry)
32
Enrollment
1
Location
4
Arms
18
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: EO2002
  • Other: Sham injection
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
2 arms are masked as indicated and 2 arms are open label
Primary Purpose:
Treatment
Official Title:
Phase 1, Randomized, Masked, Sham-Controlled Study to Assess the Safety and Tolerability of EO2002 in Subjects Undergoing Cataract Surgery
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment at time of surgery

EO2002 intracameral injection

Biological: EO2002
Intracameral injection of a single dose of magnetic human corneal endothelial cells (EO2002) either at the time of cataract surgery or post-cataract surgery
Other Names:
  • Magnetic Human Corneal Endothelial Cells

    		•
    Experimental: Treatment post surgery

    EO2002 intracameral injection

    Biological: EO2002
    Intracameral injection of a single dose of magnetic human corneal endothelial cells (EO2002) either at the time of cataract surgery or post-cataract surgery
    Other Names:
  • Magnetic Human Corneal Endothelial Cells

    		•
    Active Comparator: Treatment at time of or post surgery

    EO2002 intracameral injection

    Biological: EO2002
    Intracameral injection of a single dose of magnetic human corneal endothelial cells (EO2002) either at the time of cataract surgery or post-cataract surgery
    Other Names:
  • Magnetic Human Corneal Endothelial Cells

    		•
    Sham Comparator: Sham injection at time of or post surgery

    Sham injection

    Other: Sham injection
    Sham injection

    Outcome Measures

    Primary Outcome Measures

    1. Safety and Tolerability of EO2002 [26 weeks]

      Incidence of Treatment-Emergent Adverse Events

    Secondary Outcome Measures

    1. Endothelial Cell Density [26 weeks]

      Changes in ECD compared to baseline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    1. Age ≥ 18 years.

    2. Subject has uncomplicated history of cataract that has progressed to a level requiring standard cataract extraction with intraocular lens implant surgery.

    3. Decreased endothelial cell count

    Exclusion Criteria:

    All ocular criteria apply to study eye unless otherwise noted.

    1. Other corneal disease

    2. Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.

    3. Descemet membrane detachment.

    4. History of uveitis or other ocular inflammatory disease.

    5. History of incisional glaucoma surgery

    6. Prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty.

    7. History of ocular neoplasm.

    8. ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20/200).

    9. 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.

    10. 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.

    11. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asociacion para Evitar la Ceguera en Mexico Mexico City Cdmx Mexico 04030

    Sponsors and Collaborators

    • Asociación para Evitar la Ceguera en México
    • Emmecell

    Investigators

    • Principal Investigator: Valeria Sanchez Huerta, MD, Asociacion para Evitar la Ceguera

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Asociación para Evitar la Ceguera en México
    ClinicalTrials.gov Identifier:
    NCT05587205
    Other Study ID Numbers:
    • VSH-002
    First Posted:
    Oct 19, 2022
    Last Update Posted:
    Dec 2, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cataract
    Corneal Endothelial Cell Loss

    Study Results

    No Results Posted as of Dec 2, 2022