Trial of Netarsudil for Acceleration of Corneal Endothelial Restoration

NCT03971357 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 2018-009
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fuchs' Endothelial Dystrophy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Netarsudil

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Netarsudil DRUG

netarsudil opthalmic solution 0.02%

Also known as: Rhopressa

Netarsudil

Placebo DRUG

Placebo eye drops

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Price Vision Group: lead

Study Sites (1)

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

Related Publications (5)

• 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.

  PMID: 25299425 BACKGROUND

• 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.

  PMID: 28476048 BACKGROUND

• 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.

  PMID: 27310885 BACKGROUND

• Soh YQ, Mehta JS. Regenerative Therapy for Fuchs Endothelial Corneal Dystrophy. Cornea. 2018 Apr;37(4):523-527. doi: 10.1097/ICO.0000000000001518.

  PMID: 29384808 BACKGROUND

• 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.

  PMID: 30104038 BACKGROUND

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Interventions

netarsudil

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Marianne Price
• Organization: Price Vision Group

mprice@cornea.org

317-814-2990

Study Officials

• Francis W Price, Jr, MD

  Price Vision Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 3, 2019
• Study Start: July 22, 2019
• Primary Completion: August 26, 2021
• Study Completion: August 26, 2021
• Last Updated: February 6, 2023
• Results First Posted: February 6, 2023

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)