NCT04018417 is a Phase 2, PHASE3 clinical trial of Amphotericin B in Fuchs' Endothelial Dystrophy, sponsored by Cornea Research Foundation of America.

Who is sponsoring NCT04018417?

NCT04018417 is sponsored by Cornea Research Foundation of America.

What drugs are being tested in NCT04018417?

Interventions in NCT04018417: Amphotericin B.

What condition does NCT04018417 study?

NCT04018417 studies Fuchs' Endothelial Dystrophy.

Is NCT04018417 still recruiting?

NCT04018417 is currently withdrawn. Last updated 12 July 2019.

Last reviewed 2019-07-12 · How we verify

NCT04018417

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Withdrawn Phase 2, PHASE3 Last updated 12 July 2019

What this trial tests

Phase 2, PHASE3 trial testing Amphotericin B in Fuchs' Endothelial Dystrophy. Withdrawn.

Timeline

3 July 2019

Primary endpoint
3 July 2019

3 July 2019

Quick facts

Lead sponsor	Cornea Research Foundation of America
Phase	Phase 2, PHASE3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Start date	3 July 2019
Primary completion	3 July 2019
Estimated completion	3 July 2019
Sites	1 location across United States

Drugs / interventions tested

Amphotericin B (AMPHOTERICIN B) — full drug profile →

Conditions studied

Fuchs' Endothelial Dystrophy — all drugs for Fuchs' Endothelial Dystrophy →

Sponsor

Cornea Research Foundation of America

Who can join

18 and older, any sex, with Fuchs' Endothelial Dystrophy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Sixty years of Amphotericin B: An Overview of the Main Antifungal Agent Used to Treat Invasive Fungal Infections.
Cavassin FB, Baú-Carneiro JL, Vilas-Boas RR, Queiroz-Telles F. · · 2021 · cited 208× · PMID 33523419 · DOI 10.1007/s40121-020-00382-7
Therapeutic future of Fuchs endothelial corneal dystrophy: An ongoing way to explore.
Liu JX, Chiang TL, Hung KF, Sun YC. · · 2024 · cited 5× · PMID 38654984 · DOI 10.4103/tjo.tjo-d-23-00115
Recent advances and future challenges in nanosystems for ocular drug delivery.
Shahror RA, Fouda AY. · · 2025 · cited 1× · PMID 41478665 · DOI 10.1016/j.jpet.2025.103738

Verify or expand the search:

Other trials of Amphotericin B

Trials testing the same drug.

NCT07191756 — Amphotericin B Versus Isavuconazole for Mucormycosis: A Comparative Efficacy and Safety Study · active not recruiting
NCT06926569 — Single High-dose of Liposomal Amphotericin B in Combination With B/F/TAF for HIV/AIDS-associated Talaromycosis · NA · not yet recruiting
NCT06413056 — Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection · Phase 4 · completed
NCT04140461 — AmB Dose for Cryptococcal Meningitis · Phase 3 · unknown
NCT04031833 — Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial (EnACT) · Phase 1, PHASE2 · completed

Other recruiting trials for Fuchs' Endothelial Dystrophy

Currently open trials in the same condition.

NCT06261346 — Plasma Rich in Growth Factors in Corneal Endothelial Transplantation · NA · recruiting
NCT06881771 — FECD-TRACE: Fuchs' Endothelial Corneal Dystrophy TRAjectory and Correlation With Genotype in the United Kingdom · recruiting
NCT05275972 — Descemet Endothelial Thickness Comparison Trial II · Phase 3 · recruiting
NCT05636579 — Study to Assess Safety and Tolerability of Multiple Doses of EO2002 · Phase 1 · recruiting
NCT05436665 — The Belgian Endothelial Surgical Transplant of the Cornea · NA · recruiting

Other Cornea Research Foundation of America trials

Trials by the same sponsor.

NCT03248037 — Trial of Netarsudil for Prevention of Corticosteroid-induced Intraocular Pressure Elevation · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04018417 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cornea Research Foundation of America
Last refreshed: 12 July 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04018417.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing