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

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.

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Key information

Conditions

Corneal Edema Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Eye Diseases Eye Diseases, Hereditary Fuchs' Endothelial Dystrophy Genetic Diseases, Inborn

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Orange County Ophthalmology, Garden Grove, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults aged 18 years or older
Documented diagnosis of FCD
Evidence of central corneal edema, in at least one eye, at the Screening and Baseline Visit, in the eligible eye(s)
Reduced BCVA secondary to central corneal edema, at Screening and Baseline, in the eligible eye(s)

Exclusion criteria

FCD so advanced that, in the opinion of the Investigator, surgery would likely be required in the study eligible eye(s) within the study period
Clinically significant ocular disease (other than FCD) or trauma in the eligible eye(s) which could interfere with study interpretation
History of ocular surgery within 6 months of the Screening Visit, or any prior corneal refractive surgery in the eligible eye(s)

Treatment and study plan

Netarsudil Ophthalmic

Drug

Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution

Other names: Rhopressa®

Primary outcomes

Central Corneal Thickness (CCT)

Time frame: Baseline & 4 weeks

Mean change from baseline in CCT by ultrasound pachymetry

Sponsors and collaborators

Lead sponsor

Aerie Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Open-Label, Parallel-Group Study to Evaluate the Safety and Efficacy of Two Dosing Regimens of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy

Acronym: Fuchs

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Aug 4, 2020
Registry last updated: Sep 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed