Evaluation of Amphotericin B in Optisol-GS for Prevention of Post-Keratoplasty Fungal Infections.
NCT ID: NCT04018417
Last Updated: 2019-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2/PHASE3
INTERVENTIONAL
2019-07-03
2019-07-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Amphotericin B
The eye bank will add amphotericin B 0.255 μg/mL to the Optisol-GS donor cornea storage solution.
Amphotericin B
Drug concentration: 0.255 μg/mL
Control
The donor cornea will be stored in Optisol-GS per the eye bank's standard procedure.
No interventions assigned to this group
Interventions
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Amphotericin B
Drug concentration: 0.255 μg/mL
Eligibility Criteria
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Inclusion Criteria
* Scheduled to have Descemet membrane endothelial keratoplasty
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Cornea Research Foundation of America
OTHER
Responsible Party
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Principal Investigators
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Francis W Price, Jr, MD
Role: PRINCIPAL_INVESTIGATOR
Price Vision Group
Locations
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Price Vision Group
Indianapolis, Indiana, United States
Countries
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References
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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.
Armitage WJ. Preservation of Human Cornea. Transfus Med Hemother. 2011;38(2):143-147. doi: 10.1159/000326632. Epub 2011 Mar 16.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2019-005
Identifier Type: -
Identifier Source: org_study_id
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