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NCT04498169: Fuchs

A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy

Completed Phase 2 Results posted Last updated 15 September 2022
What this trial tests

Phase 2 trial testing Netarsudil Ophthalmic in Corneal Edema in 40 participants. Completed in 11 August 2021.

Timeline
17 September 2020
Primary endpoint
11 August 2021
11 August 2021

Quick facts

Lead sponsorAerie Pharmaceuticals
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment40
Start date17 September 2020
Primary completion11 August 2021
Estimated completion11 August 2021
Sites12 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Aerie Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Corneal Edema. 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.

Central Corneal Thickness (CCT) Primary · Baseline & 4 weeks

Mean change from baseline in CCT by ultrasound pachymetry

GroupValue95% CI
Once Daily Netarsudil Ophthalmic Solution-28.4± 35.72
Twice Daily Netarsudil Ophthalmic Solution-20.1± 39.12

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were documented from the time of signing the informed consent until the last study visit for each participant. This was a period of approximately 8 weeks (56 days) for participants who completed the full study duration. For AEs ongoing at the time of study completion, the ongoing AE was followed-up and the participant was provided appropriate medical care until the event resolved or stabilized, the participant was lost to follow-up, or there was other resolution to the event.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Once Daily Netarsudil Ophthalmic Solution
Serious: 0/20 (0%)
Deaths: 0/20
Twice Daily Netarsudil Ophthalmic Solution
Serious: 1/20 (5%)
Deaths: 0/20

Serious adverse events (1 terms)

ReactionSystemOnce Daily Netarsudil Opht…Twice Daily Netarsudil Oph…
Viral gastroenteritisGastrointestinal disorders
Other adverse events (3 terms — click to expand)

ReactionSystemOnce Daily Netarsudil Opht…Twice Daily Netarsudil Oph…
Conjunctival hypaeremiaEye disorders
Corneal verticillataEye disorders
Erythema of eyelidEye disorders

Most-reported serious reactions: Viral gastroenteritis.

Data from ClinicalTrials.gov NCT04498169 adverse events section.

Sponsor's own description

Two different dosing regimens (QD and BID) of netarsudil will be studied to evaluate their efficacy in reducing or resolving corneal edema in subjects with FCD.

Publications & conference data

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

  1. Rho-Kinase as a Target for Cancer Therapy and Its Immunotherapeutic Potential.
    Kim S, Kim SA, Han J, Kim IS. · · 2021 · cited 50× · PMID 34884721 · DOI 10.3390/ijms222312916
  2. Phase 2, Randomized, Open-Label Parallel-Group Study of Two Dosing Regimens of Netarsudil for the Treatment of Corneal Edema Due to Fuchs Corneal Dystrophy.
    Lindstrom RL, Lewis AE, Holland EJ, Sheppard JD, et al · · 2022 · cited 13× · PMID 36327101 · DOI 10.1089/jop.2022.0069
  3. 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

Verify or expand the search:

Other trials of Netarsudil Ophthalmic

Trials testing the same drug.

Other recruiting trials for Corneal Edema

Currently open trials in the same condition.

Other Aerie Pharmaceuticals trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT04498169.

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