Trial of Netarsudil for Acceleration of Corneal Endothelial Restoration

Prospective Randomized Study to Determine Whether Use of Rhopressa™ Accelerates Corneal Clearing After Removal of Descemet Membrane for Treatment of Fuchs Dystrophy

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.

Study Overview

• Status: Terminated
• Conditions: Fuchs' Endothelial Dystrophy
• Intervention / Treatment: Drug: Netarsudil; Drug: Placebo

Detailed Description

Subjects with Fuchs endothelial dystrophy will have the central corneal endothelium and guttae-covered Descemet membrane surgically removed. Subjects will be randomized to use netarsudil or placebo eye drops once daily. Visual acuity, corneal clearing and central endothelial cell density will be monitored for the 3-month study duration.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Price Vision Group

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:

• Male or female patient at least 18 years of age and of any race or ethnicity who is undergoing Descemet stripping only for Fuchs dystrophy
• Is able and willing to administer eye drops
• Is able to comprehend and has signed the Informed Consent form.

Exclusion Criteria:

• Active intraocular inflammation
• Corneal ulceration, keratitis, or conjunctivitis
• Known sensitivity to any of the ingredients in the study medications
• Abnormal eyelid function
• History of herpetic keratitis
• History of non-compliance with using prescribed medication
• Current or planned pregnancy within the study duration
• Concurrent involvement or participation in another randomized clinical trial within 30 days prior to enrollment in this study
• Any ocular or systemic condition (i.e., UNCONTROLLED systemic disease) or situation which in the investigator's opinion may put the patient at significant risk, confound the study results, or interfere significantly with the patient's participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Netarsudil; Netarsudil ophthalmic solution 0.02%, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner	Drug: Netarsudil; netarsudil opthalmic solution 0.02%; Other Names: Rhopressa
PLACEBO_COMPARATOR: Placebo; Placebo eye drop, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner.	Drug: Placebo; Placebo eye drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal Clearing After Endothelial Removal for Treatment of Fuchs Dystrophy	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 area stripped.	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to complete corneal clearing	Number of days from endothelial removal to complete corneal clearing	3 months
Central endothelial cell density	Central corneal endothelial cell density assessed with specular microscopy	3 months
Time to reach corrected distance visual acuity of 20/40 or better	Number of days from endothelial removal to recovery of corrected distance visual acuity of 20/40 or better	3 months

Collaborators and Investigators

• Sponsor: Price Vision Group

Publications and helpful links

General Publications

• Arbelaez JG, Price MO, Price FW Jr. Long-term follow-up and complications of stripping descemet membrane without placement of graft in eyes with Fuchs endothelial dystrophy. Cornea. 2014 Dec;33(12):1295-9. doi: 10.1097/ICO.0000000000000270.
• Moloney G, Petsoglou C, Ball M, Kerdraon Y, Hollhumer R, Spiteri N, Beheregaray S, Hampson J, D'Souza M, Devasahayam RN. Descemetorhexis Without Grafting for Fuchs Endothelial Dystrophy-Supplementation With Topical Ripasudil. Cornea. 2017 Jun;36(6):642-648. doi: 10.1097/ICO.0000000000001209.
• Borkar DS, Veldman P, Colby KA. Treatment of Fuchs Endothelial Dystrophy by Descemet Stripping Without Endothelial Keratoplasty. Cornea. 2016 Oct;35(10):1267-73. doi: 10.1097/ICO.0000000000000915.
• Soh YQ, Mehta JS. Regenerative Therapy for Fuchs Endothelial Corneal Dystrophy. Cornea. 2018 Apr;37(4):523-527. doi: 10.1097/ICO.0000000000001518.
• Wacker K, Baratz KH, Bourne WM, Patel SV. Patient-Reported Visual Disability in Fuchs' Endothelial Corneal Dystrophy Measured by the Visual Function and Corneal Health Status Instrument. Ophthalmology. 2018 Dec;125(12):1854-1861. doi: 10.1016/j.ophtha.2018.06.018. Epub 2018 Aug 10.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 22, 2019
• Primary Completion (ACTUAL): August 26, 2021
• Study Completion (ACTUAL): August 26, 2021

Study Registration Dates

• First Submitted: May 30, 2019
• First Submitted That Met QC Criteria: May 30, 2019
• First Posted (ACTUAL): June 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Corneal Diseases; Corneal Dystrophies, Hereditary; Fuchs' Endothelial Dystrophy
• Other Study ID Numbers: 2018-009

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