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

Fuchs' Endothelial Dystrophy Clinical Trial

Official title:

A Randomized, Double-masked, Placebo-controlled Study of the Safety of Amphotericin 0.255 μg/mL in Optisol-GS

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04018417
• Other study ID #: 2019-005
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: July 3, 2019
• Est. completion date: July 3, 2019

Study information

• Verified date: July 2019
• Source: Cornea Research Foundation of America
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 3, 2019
• Est. primary completion date: July 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fuchs' Endothelial Dystrophy

Intervention

Drug:
• Amphotericin B
Drug concentration: 0.255 µg/mL

Locations

Country	Name	City	State
United States	Price Vision Group	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Cornea Research Foundation of America

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Armitage WJ. Preservation of Human Cornea. Transfus Med Hemother. 2011;38(2):143-147. Epub 2011 Mar 16. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Merchant A, Zacks CM, Wilhelmus K, Durand M, Dohlman CH. Candidal endophthalmitis after keratoplasty. Cornea. 2001 Mar;20(2):226-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial cell density	Central corneal endothelial cell density will be assessed by specular microscopy	6 months
Secondary	Incidence of post-keratoplasty fungal keratitis	The incidence of post-keratoplasty fungal keratitis will be assessed.	6 months