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Phase 1 Study to Evaluate the Safety and Tolerability of EO1404 in the Treatment of Corneal Edema

Primary Purpose

Corneal Edema, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy

Status
Unknown status
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
EO1404
Endothelial brushing or Descemet stripping
Sponsored by
Valeria Sanchez-Huerta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Edema

Eligibility Criteria

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

Inclusion Criteria:

  1. Age ≥ 21 years
  2. Pseudophakic with a posterior chamber intraocular lens.
  3. Symptomatic corneal edema associated with endothelial dysfunction which may be secondary to Fuchs corneal dystrophy or pseudophakic bullous keratopathy.

    a Symptoms including reduced vision and/or glare, and/or pain; subject may or may not have been on topical therapies such as 5% sodium chloride drops or prednisolone acetate 1% drops.

    b ETDRS-best corrected visual acuity worse than 20/63 on Snellen. c Central corneal thickness < 2 mm by ultrasound pachymetry or OCT. d Subject must have progressed far enough in their clinical course to be considered a surgical candidate for full-thickness corneal transplantation or endothelial keratoplasty.

  4. Subject must understand and sign the informed consent. If the subject's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the subject in their maternal language.
  5. Subject must be medically able and willing to undergo the protocol-required procedures.

Exclusion Criteria:

All ocular criteria apply to study eye unless otherwise noted.

  1. Other corneal disease, including active or prior herpetic ocular infection; active inflammation; corneal scarring from trauma, burns, or infection; or band keratopathy.
  2. Visual acuity in the fellow eye is worse than 20/200.
  3. Anterior chamber intraocular lens.
  4. Subject requires topical, intravenous or oral acyclovir and/or related products during study duration
  5. History of vitrectomy.
  6. History of refractive surgery.
  7. Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.
  8. Prior incisional eye surgery within 3 months prior to study treatment.
  9. Subject is receiving systemic steroids or other systemic immunosuppressive medications.
  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. History of uveitis or other ocular inflammatory disease.
  12. History of glaucoma, or peripheral anterior synechiae on gonioscopy.
  13. History of incisional glaucoma surgery (e.g., trabeculectomy, glaucoma drainage implant).
  14. Female subject 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.
  15. Subject is immunodeficient, or tested positive for HIV.
  16. Subject is on chemotherapy.
  17. History of malignancy other than basal cell carcinoma, UNLESS the malignancy was treated successfully 5 years prior to inclusion in the study.
  18. History of ocular neoplasm.

Sites / Locations

  • Asociación Para Evitar la Ceguera en México, IAP, Hospital "Dr. Luis Sánchez Bulnes"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

50K to 200K cells

50K to 200K cells with endothelial brushing

500K cells

500K cells with endothelial brushing

Arm Description

Outcomes

Primary Outcome Measures

Evaluation of Adverse Events
Evaluation of safety adverse events including worsening of corneal edema and increase in intraocular pressure

Secondary Outcome Measures

BVCA
Best corrected visual acuity
Corneal thickness
Decrease in corneal thickness

Full Information

First Posted
December 4, 2019
Last Updated
December 5, 2019
Sponsor
Valeria Sanchez-Huerta
Collaborators
Emmecell
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1. Study Identification

Unique Protocol Identification Number
NCT04191629
Brief Title
Phase 1 Study to Evaluate the Safety and Tolerability of EO1404 in the Treatment of Corneal Edema
Official Title
Phase 1 Clinical Study to Evaluate Safety and Tolerability of Magnetic Human Corneal Endothelial Cells in the Treatment of Corneal Edema
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 4, 2016 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
February 28, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Valeria Sanchez-Huerta
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
Yes

5. Study Description

Brief Summary
Single center, phase 1 study to evaluate the safety and tolerability of EO1404 in subjects with corneal edema secondary to pseudophakic bullous keratopathy or Fuch's endothelial dystrophy.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
50K to 200K cells
Arm Type
Experimental
Arm Title
50K to 200K cells with endothelial brushing
Arm Type
Experimental
Arm Title
500K cells
Arm Type
Experimental
Arm Title
500K cells with endothelial brushing
Arm Type
Experimental
Intervention Type
Combination Product
Intervention Name(s)
EO1404
Other Intervention Name(s)
Magnetic Human Corneal Endothelial Cells
Intervention Type
Procedure
Intervention Name(s)
Endothelial brushing or Descemet stripping
Primary Outcome Measure Information:
Title
Evaluation of Adverse Events
Description
Evaluation of safety adverse events including worsening of corneal edema and increase in intraocular pressure
Time Frame
12 months
Secondary Outcome Measure Information:
Title
BVCA
Description
Best corrected visual acuity
Time Frame
12 months
Title
Corneal thickness
Description
Decrease in corneal thickness
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 21 years Pseudophakic with a posterior chamber intraocular lens. Symptomatic corneal edema associated with endothelial dysfunction which may be secondary to Fuchs corneal dystrophy or pseudophakic bullous keratopathy. a Symptoms including reduced vision and/or glare, and/or pain; subject may or may not have been on topical therapies such as 5% sodium chloride drops or prednisolone acetate 1% drops. b ETDRS-best corrected visual acuity worse than 20/63 on Snellen. c Central corneal thickness < 2 mm by ultrasound pachymetry or OCT. d Subject must have progressed far enough in their clinical course to be considered a surgical candidate for full-thickness corneal transplantation or endothelial keratoplasty. Subject must understand and sign the informed consent. If the subject's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the subject in their maternal language. Subject must be medically able and willing to undergo the protocol-required procedures. Exclusion Criteria: All ocular criteria apply to study eye unless otherwise noted. Other corneal disease, including active or prior herpetic ocular infection; active inflammation; corneal scarring from trauma, burns, or infection; or band keratopathy. Visual acuity in the fellow eye is worse than 20/200. Anterior chamber intraocular lens. Subject requires topical, intravenous or oral acyclovir and/or related products during study duration History of vitrectomy. History of refractive surgery. Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA. Prior incisional eye surgery within 3 months prior to study treatment. Subject is receiving systemic steroids or other systemic immunosuppressive medications. 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. History of uveitis or other ocular inflammatory disease. History of glaucoma, or peripheral anterior synechiae on gonioscopy. History of incisional glaucoma surgery (e.g., trabeculectomy, glaucoma drainage implant). Female subject 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 immunodeficient, or tested positive for HIV. Subject is on chemotherapy. History of malignancy other than basal cell carcinoma, UNLESS the malignancy was treated successfully 5 years prior to inclusion in the study. History of ocular neoplasm.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valeria Sanchez-Huerta, MD
Phone
+5210841400
Ext
1234
Email
valeriash@gmail.com
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
Asociación Para Evitar la Ceguera en México, IAP, Hospital "Dr. Luis Sánchez Bulnes"
City
Mexico City
ZIP/Postal Code
04030
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanchez-Huerta Valeria, MD
Phone
10841400
Ext
1043
First Name & Middle Initial & Last Name & Degree
Sanchez-Huerta Valeria, MD
First Name & Middle Initial & Last Name & Degree
De Wit Carter Guillermo, MD
First Name & Middle Initial & Last Name & Degree
Hernandez-Chavarria Cesar, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Phase 1 Study to Evaluate the Safety and Tolerability of EO1404 in the Treatment of Corneal Edema

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