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出境医 / 临床实验 / Evaluation of Amphotericin B in Optisol-GS for Prevention of Post-Keratoplasty Fungal Infections.

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

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
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
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 [ 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

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
Tracking Information
First Submitted Date  ICMJE July 11, 2019
First Posted Date  ICMJE July 12, 2019
Last Update Posted Date July 12, 2019
Actual Study Start Date  ICMJE July 3, 2019
Actual Primary Completion Date July 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2019) 		Endothelial cell density [ Time Frame: 6 months ]
Central corneal endothelial cell density will be assessed by specular microscopy
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2019) 		Incidence of post-keratoplasty fungal keratitis [ Time Frame: 6 months ]
The incidence of post-keratoplasty fungal keratitis will be assessed.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Amphotericin B in Optisol-GS for Prevention of Post-Keratoplasty Fungal Infections.
Official Title  ICMJE A Randomized, Double-masked, Placebo-controlled Study of the Safety of Amphotericin 0.255 μg/mL in Optisol-GS
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Fuchs' Endothelial Dystrophy
Intervention  ICMJE Drug: Amphotericin B
Drug concentration: 0.255 μg/mL
Study Arms  ICMJE
  • Experimental: Amphotericin B
    The eye bank will add amphotericin B 0.255 μg/mL to the Optisol-GS donor cornea storage solution.
    Intervention: Drug: Amphotericin B
  • No Intervention: Control
    The donor cornea will be stored in Optisol-GS per the eye bank's standard procedure.
Publications *
  • 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. 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.
  • 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.
  • Merchant A, Zacks CM, Wilhelmus K, Durand M, Dohlman CH. Candidal endophthalmitis after keratoplasty. Cornea. 2001 Mar;20(2):226-9. Review.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 11, 2019) 		0
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 3, 2019
Actual Primary Completion Date July 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04018417
Other Study ID Numbers  ICMJE 2019-005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cornea Research Foundation of America
Study Sponsor  ICMJE Cornea Research Foundation of America
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francis W Price, Jr, MD Price Vision Group
PRS Account Cornea Research Foundation of America
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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