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

Primary Purpose

Fuchs' Endothelial Dystrophy

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Amphotericin B
Sponsored by
Cornea Research Foundation of America
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fuchs' Endothelial Dystrophy

Eligibility Criteria

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

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

Sites / Locations

  • Price Vision Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Amphotericin B

Control

Arm Description

The eye bank will add amphotericin B 0.255 μg/mL to the Optisol-GS donor cornea storage solution.

The donor cornea will be stored in Optisol-GS per the eye bank's standard procedure.

Outcomes

Primary Outcome Measures

Endothelial cell density
Central corneal endothelial cell density will be assessed by specular microscopy

Secondary Outcome Measures

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

Full Information

First Posted
July 11, 2019
Last Updated
July 11, 2019
Sponsor
Cornea Research Foundation of America
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1. Study Identification

Unique Protocol Identification Number
NCT04018417
Brief Title
Evaluation of Amphotericin B in Optisol-GS for Prevention of Post-Keratoplasty Fungal Infections.
Official Title
A Randomized, Double-masked, Placebo-controlled Study of the Safety of Amphotericin 0.255 μg/mL in Optisol-GS
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Reconsidered significance in light of newly published in vitro data.
Study Start Date
July 3, 2019 (Actual)
Primary Completion Date
July 3, 2019 (Actual)
Study Completion Date
July 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cornea Research Foundation of America

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuchs' Endothelial Dystrophy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amphotericin B
Arm Type
Experimental
Arm Description
The eye bank will add amphotericin B 0.255 μg/mL to the Optisol-GS donor cornea storage solution.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The donor cornea will be stored in Optisol-GS per the eye bank's standard procedure.
Intervention Type
Drug
Intervention Name(s)
Amphotericin B
Intervention Description
Drug concentration: 0.255 μg/mL
Primary Outcome Measure Information:
Title
Endothelial cell density
Description
Central corneal endothelial cell density will be assessed by specular microscopy
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Incidence of post-keratoplasty fungal keratitis
Description
The incidence of post-keratoplasty fungal keratitis will be assessed.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis W Price, Jr, MD
Organizational Affiliation
Price Vision Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Price Vision Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23051906
Citation
Aldave AJ, DeMatteo J, Glasser DB, Tu EY, Iliakis B, Nordlund ML, Misko J, Verdier DD, Yu F. Report of the Eye Bank Association of America medical advisory board subcommittee on fungal infection after corneal transplantation. Cornea. 2013 Feb;32(2):149-54. doi: 10.1097/ICO.0b013e31825e83bf.
Results Reference
background
PubMed Identifier
21566714
Citation
Armitage WJ. Preservation of Human Cornea. Transfus Med Hemother. 2011;38(2):143-147. doi: 10.1159/000326632. Epub 2011 Mar 16.
Results Reference
background
PubMed Identifier
15808165
Citation
Hassan SS, Wilhelmus KR; Medical Review Subcommittee of the Eye Bank Association of America. Eye-banking risk factors for fungal endophthalmitis compared with bacterial endophthalmitis after corneal transplantation. Am J Ophthalmol. 2005 Apr;139(4):685-90. doi: 10.1016/j.ajo.2004.12.016.
Results Reference
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PubMed Identifier
18268215
Citation
Hassan SS, Wilhelmus KR, Dahl P, Davis GC, Roberts RT, Ross KW, Varnum BH; Medical Review Subcommittee of the Eye Bank Association of America. Infectious disease risk factors of corneal graft donors. Arch Ophthalmol. 2008 Feb;126(2):235-9. doi: 10.1001/archophthalmol.2007.45.
Results Reference
background
PubMed Identifier
15778600
Citation
Keyhani K, Seedor JA, Shah MK, Terraciano AJ, Ritterband DC. The incidence of fungal keratitis and endophthalmitis following penetrating keratoplasty. Cornea. 2005 Apr;24(3):288-91. doi: 10.1097/01.ico..0000138832.3486.70.
Results Reference
background
PubMed Identifier
11248837
Citation
Merchant A, Zacks CM, Wilhelmus K, Durand M, Dohlman CH. Candidal endophthalmitis after keratoplasty. Cornea. 2001 Mar;20(2):226-9. doi: 10.1097/00003226-200103000-00026.
Results Reference
background
PubMed Identifier
29634675
Citation
Doshi H, Pabon S, Price MO, Feng MT, Price FW Jr. Overview of Systemic Candida Infections in Hospital Settings and Report of Candida After DMEK Successfully Treated With Antifungals and Partial Graft Excision. Cornea. 2018 Aug;37(8):1071-1074. doi: 10.1097/ICO.0000000000001608.
Results Reference
background
PubMed Identifier
26914028
Citation
Duncan K, Parker J, Hoover C, Jeng BH. The Effect of Light Exposure on the Efficacy and Safety of Amphotericin B in Corneal Storage Media. JAMA Ophthalmol. 2016 Apr;134(4):432-6. doi: 10.1001/jamaophthalmol.2016.0008.
Results Reference
background
PubMed Identifier
8931814
Citation
Lopez RM, Ayestaran A, Pou L, Montoro JB, Hernandez M, Caragol I. Stability of amphotericin B in an extemporaneously prepared i.v. fat emulsion. Am J Health Syst Pharm. 1996 Nov 15;53(22):2724-7. doi: 10.1093/ajhp/53.22.2724.
Results Reference
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Evaluation of Amphotericin B in Optisol-GS for Prevention of Post-Keratoplasty Fungal Infections.

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