Evaluation of Amphotericin B in Optisol-GS for Prevention... | NCT04018417

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

NCT04018417

Sponsor

Cornea Research Foundation of America

Status

Withdrawn

Last Update Posted

Jul 12, 2019Actual

Enrollment

0Actual

Phase

Phase 2Phase 3

Conditions

Fuchs' Endothelial Dystrophy

Interventions

Amphotericin B

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Reconsidered significance in light of newly published in vitro data.

Expanded Access Info

Start Date

Jul 3, 2019Actual

Primary Completion Date

Jul 3, 2019Actual

Completion Date

Jul 3, 2019Actual

First Submitted Date

Jul 11, 2019

First Submission Date that Met QC Criteria

Jul 11, 2019

First Posted Date

Jul 12, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2019

Last Update Posted Date

Jul 12, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Amphotericin B	Drug	Drug concentration: 0.255 μg/mL	Amphotericin B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Endothelial cell density	Central corneal endothelial cell density will be assessed by specular microscopy	6 months

Secondary Outcomes

Measure	Description	Time Frame
Incidence of post-keratoplasty fungal keratitis	The incidence of post-keratoplasty fungal keratitis will be assessed.	6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Francis W Price, Jr, MD	Price Vision Group	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Price Vision Group		Indianapolis	Indiana	46260	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23051906	Background	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.
21566714	Background

ID	Term
D003317	Corneal Dystrophies, Hereditary
D003316	Corneal Diseases
D005128	Eye Diseases
D015785	Eye Diseases, Hereditary

ID	Term
D018942	Macrolides
D061065	Polyketides
D007783	Lactones
D009930	Organic Chemicals