Trial of Netarsudil for Acceleration of Corneal Endothelial Restoration

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.

• Netarsudil (Drug), also known as Rhopressa: netarsudil opthalmic solution 0.02%
• Placebo (Drug): Placebo eye drops

Primary outcomes

• Corneal Clearing After Endothelial Removal for Treatment of Fuchs Dystrophy [5 weeks]: 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.

Sex: All, ages: 18 Years to any

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.

Participant flow

Outcome results

• Corneal Clearing After Endothelial Removal for Treatment of Fuchs Dystrophy (Primary), Mean, percentage of area stripped: Netarsudil 42 +/- 45; Placebo 43 +/- 49

Adverse events

Time frame: 3 months

Other adverse events by term

• 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
• 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
• 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
• 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
• 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

• Study Protocol and Statistical Analysis Plan (PDF, 2019-07-25)

• Francis W Price, Jr, MD, Principal investigator, Price Vision Group