NCT03971357

Trial of Netarsudil for Acceleration of Corneal Endothelial Restoration

Terminated Phase 2, PHASE3 Results posted Last updated 6 February 2023

What this trial tests

Phase 2, PHASE3 trial testing Netarsudil in Fuchs' Endothelial Dystrophy in 19 participants. Terminated before completion.

Timeline

22 July 2019

Primary endpoint
26 August 2021

26 August 2021

Quick facts

Lead sponsor	Price Vision Group
Phase	Phase 2, PHASE3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	19
Start date	22 July 2019
Primary completion	26 August 2021
Estimated completion	26 August 2021
Sites	1 location across United States

Drugs / interventions tested

• Netarsudil (NETARSUDIL) — full drug profile →
• Placebo

Conditions studied

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

Sponsor

Price Vision Group — full company profile →

Who can join

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

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Corneal Clearing After Endothelial Removal for Treatment of Fuchs Dystrophy Primary · 5 weeks

The outcome measure was the percentage area of the cornea that remained edematous after removal of the endothelium. At the time of surgery, the surgeon recorded the lengths of the major and minor axes of the approximately circular area of endothelium removal; these values were used to calculate the area of stripping. At each postoperative exam, the examiner recorded the lengths of the major and minor axes of the edematous area; these values were used to calculate the area of edema. The percentage that remained edematous at 5 weeks was calculated by dividing the area of edema at 5 weeks by the

Group	Value	95% CI
Netarsudil	42	± 45
Placebo	43	± 49

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Netarsudil

Serious: 0/10 (0%)

Deaths: 0/10

Placebo

Serious: 0/9 (0%)

Deaths: 0/9

Other adverse events (3 terms — click to expand)

Reaction	System	Netarsudil	Placebo
eye discomfort	Eye disorders	—	—
cystoid macular edema	Eye disorders	—	—
microcystic corneal epithelial bullae	Eye disorders	—	—

Data from ClinicalTrials.gov NCT03971357 adverse events section.

Sponsor's own description

Subjects with Fuchs dystrophy will be randomized to use either netarsudil or placebo eye drops to determine if the use of netarsudil accelerates migration of host peripheral corneal endothelial cells to restore the central endothelial cell layer.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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