Trial of Netarsudil for Acceleration of Corneal Endothelial Restoration

• Sponsor: Price Vision Group (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03971357
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 2
• Actual Duration (Months): 25.2
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fuchs' Endothelial Dystrophy	Drug: Netarsudil; Drug: Placebo	Phase 2/Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Prospective Randomized Study to Determine Whether Use of Rhopressa™ Accelerates Corneal Clearing After Removal of Descemet Membrane for Treatment of Fuchs Dystrophy
• Actual Study Start Date: Jul 22, 2019
• Actual Primary Completion Date: Aug 26, 2021
• Actual Study Completion Date: Aug 26, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Rate of corneal clearing after endothelial removal for treatment of Fuchs dystrophy [6 weeks]

   Area of cornea that has not cleared as a proportion of the area stripped of endothelium

Secondary Outcome Measures

1. Time to complete corneal clearing [3 months]

   Number of days from endothelial removal to complete corneal clearing

2. Central endothelial cell density [3 months]

   Central corneal endothelial cell density assessed with specular microscopy

3. Time to reach corrected distance visual acuity of 20/40 or better [3 months]

   Number of days from endothelial removal to recovery of corrected distance visual acuity of 20/40 or better

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Price Vision Group	Indianapolis	Indiana	United States	46260

Sponsors and Collaborators

• Price Vision Group

Investigators

• Principal Investigator: Francis W Price, Jr, MD, Price Vision Group

Study Documents (Full-Text)

None provided.

More Information

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.
• 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.
• Moloney G, Petsoglou C, Ball M, Kerdraon Y, Höllhumer 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.
• 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.

• Responsible Party: Price Vision Group
• ClinicalTrials.gov Identifier: NCT03971357
• Other Study ID Numbers: 2018-009
• First Posted: Jun 3, 2019
• Last Update Posted: Sep 2, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fuchs' Endothelial Dystrophy

Study Results

No Results Posted as of Sep 2, 2021