Trial of Netarsudil for Acceleration of Corneal Endothelial Restoration

Phase 3TerminatedNCT03971357

Price Vision Group19 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Fuchs' Endothelial Dystrophy

Interventions

NetarsudilDRUG

netarsudil opthalmic solution 0.02%

PlaceboDRUG

Placebo eye drops

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Price Vision Group

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

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.

Time frame: 5 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.