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Evaluation of Amphotericin B in Optisol-GS for Prevention of Post-Keratoplasty Fungal Infections.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04018417
Recruitment Status : Withdrawn (Reconsidered significance in light of newly published in vitro data.)
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Cornea Research Foundation of America

Study Description
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Brief Summary:
With the increasing popularity of endothelial keratoplasty, a coincident increase in the rate of fungal infections post-keratoplasty has been seen in the United States. In this study, the eye bank will harvest pairs of donor corneas and randomize one cornea from each pair to be stored in Optisol-GS per Eye Bank Association of America guidelines. The eye bank will add amphotericin B 0.255 μg/mL (antifungal) to the storage solution for the mate cornea. The study donor corneas will be assigned to participants who are scheduled to undergo Descemet membrane endothelial keratoplasty. The surgeons, participants, and evaluators will remain masked regarding the donor cornea storage solution assignment. The participants will be followed for 6 months.

Condition or disease Intervention/treatment Phase
Fuchs' Endothelial Dystrophy Drug: Amphotericin B Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-masked, Placebo-controlled Study of the Safety of Amphotericin 0.255 μg/mL in Optisol-GS
Actual Study Start Date : July 3, 2019
Actual Primary Completion Date : July 3, 2019
Actual Study Completion Date : July 3, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Molds

Arms and Interventions
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Arm Intervention/treatment
Experimental: Amphotericin B
The eye bank will add amphotericin B 0.255 μg/mL to the Optisol-GS donor cornea storage solution.
 Drug: Amphotericin B
Drug concentration: 0.255 μg/mL
No Intervention: Control
The donor cornea will be stored in Optisol-GS per the eye bank's standard procedure.


Outcome Measures
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Primary Outcome Measures :
  1. Endothelial cell density [ Time Frame: 6 months ]
    Central corneal endothelial cell density will be assessed by specular microscopy


Secondary Outcome Measures :
  1. Incidence of post-keratoplasty fungal keratitis [ Time Frame: 6 months ]
    The incidence of post-keratoplasty fungal keratitis will be assessed.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female at least 18 years of age and any race or ethnicity
  • Scheduled to have Descemet membrane endothelial keratoplasty

Exclusion Criteria:

  • History of glaucoma surgery in operative eye
  • Known allergy or intolerance to amphotericin B
  • Presence of anterior chamber intraocular lens
  • Corneal stromal or epithelial dysfunction
  • Presence of glaucoma defined as optic nerve damage as confirmed on Humphrey visual field testing or retinal nerve fiber layer analysis
  • Presence of peripheral anterior synechiae
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018417


Locations
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United States, Indiana
Price Vision Group
Indianapolis, Indiana, United States, 46260
Sponsors and Collaborators
Cornea Research Foundation of America
Investigators
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Principal Investigator: Francis W Price, Jr, MD Price Vision Group
More Information
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Publications:

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Responsible Party: Cornea Research Foundation of America
ClinicalTrials.gov Identifier: NCT04018417    
Other Study ID Numbers: 2019-005
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Fuchs' Endothelial Dystrophy
Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Amphotericin B
 Liposomal amphotericin B
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents