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

NCT04018417 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 2019-005
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Fuchs' Endothelial Dystrophy

Outcome Measures

Primary Outcomes (1)

• Endothelial cell density

  Central corneal endothelial cell density will be assessed by specular microscopy

  6 months

Secondary Outcomes (1)

• Incidence of post-keratoplasty fungal keratitis

  6 months

Study Arms (2)

Amphotericin B

EXPERIMENTAL

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

Drug: Amphotericin B

Control

NO INTERVENTION

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

Interventions

Amphotericin B DRUG

Drug concentration: 0.255 μg/mL

Amphotericin B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cornea Research Foundation of America: lead

Study Sites (1)

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

Related Publications (9)

• 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.

  PMID: 23051906 BACKGROUND

• Armitage WJ. Preservation of Human Cornea. Transfus Med Hemother. 2011;38(2):143-147. doi: 10.1159/000326632. Epub 2011 Mar 16.

  PMID: 21566714 BACKGROUND

• 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.

  PMID: 15808165 BACKGROUND

• 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.

  PMID: 18268215 BACKGROUND

• 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.

  PMID: 15778600 BACKGROUND

• 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.

  PMID: 11248837 BACKGROUND

• 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.

  PMID: 29634675 BACKGROUND

• 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.

  PMID: 26914028 BACKGROUND

• 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.

  PMID: 8931814 BACKGROUND

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Interventions

Amphotericin B

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Francis W Price, Jr, MD

  Price Vision Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 12, 2019
• Study Start: July 3, 2019
• Primary Completion: July 3, 2019
• Study Completion: July 3, 2019
• Last Updated: July 12, 2019

Record last verified: 2019-07

Locations

US (1)