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

Sponsor
Cornea Research Foundation of America (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04018417
Collaborator
(none)
0
Enrollment
1
Location
2
Arms

Study Details

Study Description

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
  • Drug: Amphotericin B
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
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 :
Jul 3, 2019
Actual Primary Completion Date :
Jul 3, 2019
Actual Study Completion Date :
Jul 3, 2019

Arms and Interventions

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

Primary Outcome Measures

  1. Endothelial cell density [6 months]

    Central corneal endothelial cell density will be assessed by specular microscopy

Secondary Outcome Measures

  1. Incidence of post-keratoplasty fungal keratitis [6 months]

    The incidence of post-keratoplasty fungal keratitis will be assessed.

Eligibility Criteria

Criteria

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

Locations

Site City State Country Postal Code
1 Price Vision Group Indianapolis Indiana United States 46260

Sponsors and Collaborators

  • Cornea Research Foundation of America

Investigators

  • Principal Investigator: Francis W Price, Jr, MD, Price Vision Group

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Cornea Research Foundation of America
ClinicalTrials.gov Identifier:
NCT04018417
Other Study ID Numbers:
  • 2019-005
First Posted:
Jul 12, 2019
Last Update Posted:
Jul 12, 2019
Last Verified:
Jul 1, 2019
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:
Fuchs' Endothelial Dystrophy
Amphotericin B
Liposomal amphotericin B

Study Results

No Results Posted as of Jul 12, 2019