NCT04191629UnknownPhase 1
Phase 1 Clinical Study to Evaluate Safety and Tolerability of Magnetic Human Corneal Endothelial Cells in the Treatment of Corneal Edema
Valeria Sanchez-Huerta2 sites in 1 country35 target enrollmentStarted: May 4, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- Evaluation of Adverse Events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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/
- •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.
Outcomes
Primary Outcomes
Evaluation of Adverse Events
Time Frame: 12 months
Evaluation of safety adverse events including worsening of corneal edema and increase in intraocular pressure
Secondary Outcomes
- BVCA(12 months)
- Corneal thickness(12 months)
Investigators
Valeria Sanchez-Huerta
Academic Director
Asociación para Evitar la Ceguera en México
Study Sites (2)
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