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

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

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.

Study Overview

• Status: Completed
• Conditions: Corneal Edema
• Intervention / Treatment: Drug: Netarsudil Ophthalmic

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Garden Grove, California, United States, 92843
      • Orange County Ophthalmology
    • Laguna Hills, California, United States, 92653
      • Harvard Eye Associates
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • Cincinnati Eye Institute
  • Massachusetts
    • South Dartmouth, Massachusetts, United States, 02748
      • Advance Eye Associates
  • Minnesota
    • Bloomington, Minnesota, United States, 55420
      • Chu Vision Institute
    • Minnetonka, Minnesota, United States, 55305
      • Minnesota Eye Care
  • Missouri
    • Saint Louis, Missouri, United States, 63131
      • Ophthalmology Associates
  • North Dakota
    • W. Fargo, North Dakota, United States, 58078
      • Vance Thompson Vision
  • Ohio
    • Westerville, Ohio, United States, 43082
      • Comprehensive Eye Care
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Vance Thompson Vision
  • Texas
    • Houston, Texas, United States, 77025
      • Houston Eye Associates
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Eye Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. 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
2. Clinically significant ocular disease (other than FCD) or trauma in the eligible eye(s) which could interfere with study interpretation
3. History of ocular surgery within 6 months of the Screening Visit, or any prior corneal refractive surgery in the eligible eye(s)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Once Daily Netarsudil Ophthalmic Solution; One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the evening for an 8 week period in up to 20 subjects.	Drug: Netarsudil Ophthalmic; Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution; Other Names: Rhopressa®
Experimental: Twice Daily Netarsudil Ophthalmic Solution; One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the morning and in the evening for an 8 week period in up to 20 subjects.	Drug: Netarsudil Ophthalmic; Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution; Other Names: Rhopressa®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central Corneal Thickness (CCT)	Mean change from baseline in CCT by ultrasound pachymetry	Baseline & 4 weeks

Collaborators and Investigators

• Sponsor: Aerie Pharmaceuticals
• Investigators: Study Director: Michelle Senchyna, Ph.D., Aerie Pharmaceuticals Inc.

Publications and helpful links

General Publications

• Lindstrom RL, Lewis AE, Holland EJ, Sheppard JD, Hovanesian JA, Senchyna M, Hollander DA. 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. J Ocul Pharmacol Ther. 2022 Nov 3. doi: 10.1089/jop.2022.0069. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2020
• Primary Completion (Actual): August 11, 2021
• Study Completion (Actual): August 11, 2021

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: July 31, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): September 15, 2022
• Last Update Submitted That Met QC Criteria: August 31, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Corneal Edema; Fuchs Corneal Dystrophy; Netarsudil Ophthalmic Solution
• Additional Relevant MeSH Terms: Eye Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Corneal Diseases; Edema; Corneal Edema; Corneal Dystrophies, Hereditary; Fuchs' Endothelial Dystrophy
• Other Study ID Numbers: AR-13324-CS210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No