Trial of Netarsudil for Acceleration of Corneal Endothelial Restoration

Fuchs' Endothelial Dystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03971357
• Other study ID #: 2018-009
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: July 22, 2019
• Est. completion date: August 26, 2021

Study information

• Verified date: August 2021
• Source: Price Vision Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: August 26, 2021
• Est. primary completion date: August 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fuchs' Endothelial Dystrophy

Intervention

Drug:
• Netarsudil
netarsudil opthalmic solution 0.02%
• Placebo
Placebo eye drops

Locations

Country	Name	City	State
United States	Price Vision Group	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Price Vision Group

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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