Clinical trial NCT04191629: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Corneal Edema
Fuchs Dystrophy
Fuchs' Endothelial Dystrophy
Pseudophakic Bullous Keratopathy
Corneal Endothelial Dystrophy
Corneal Transplant Failure
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
Collaborators: name: Emmecell
First posted: 2019-12-10
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: BVCA
timeFrame: 12 months
measure: Corneal thickness
timeFrame: 12 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Asociación Para Evitar la Ceguera en México, IAP, Hospital "Dr. Luis Sánchez Bulnes"
Study officials:
affiliation: Asociacion Para Evitar la Ceguera
name: Valeria Sanchez-Huerta, MD
role: PRINCIPAL_INVESTIGATOR
References: