This study has two main objectives. The first objective is to study the pharmacokinetics of topical netarsudil administration in the posterior segment of the eye, where netarsudil must exert its effect in order to prevent formation of tractional membranes. The second objective is to assess the safety profile of topical netarsudil in the pre- and post-operative periods. A secondary objective of the study is to begin to assess signs of efficacy in preventing formation of tractional membranes post-operatively.
This is an open-label, randomized study that will test the safety and pharmacokinetics of topical netarsudil at a dose frequency of once-daily in two cohorts of patients: those with primary rhegmatogenous detachments, and those with established proliferative vitreoretinopathy. The intervention will be topical application of Netarsudil from time of diagnosis of retinal detachment to 16 weeks post-operatively. Patients will be randomized to one of the following groups: * The primary rhegmatogenous detachment cohort: A total of 24 study subjects (24 eyes) will be stratified by their lens status (12 phakic versus 12 pseudophakic). All patients will receive once per day dosing of netarsudil. * The proliferative vitreoretinopathy cohort: A total of 24 study subjects (24 eyes) will be stratified by their lens status (12 phakic versus 12 pseudophakic). All patients will receive once per day dosing of netarsudil. After surgery, patients will continue on once per day dosing of Netarsudil for a total of 16 weeks post-op.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
48
Topical administration of Netarsudil
Mass Eye and Ear
Boston, Massachusetts, United States
RECRUITINGThe concentration of netarsudil in the vitreous to assess its pharmacokinetic properties.
Netarsudil concentration in the posterior segment of the eye, using High-performance liquid chromatography (HPLC)
Time frame: Through study completion, an average of 1 year
Serious adverse events
Unexpected serious adverse events
Time frame: Day 1, 7, 28, 84, and 168 after surgery
Number of operations within 3 months
Total number of operation during the first 3 months after surgery
Time frame: Day 84 after surgery
Final attachment status at last follow-up
Status of the retina (attached versus detached) at last follow-up visit
Time frame: Day 168 after surgery
Visual acuity
Best-corrected visual acuity measured using Snellen chart
Time frame: Day 1, 7, 28, 84, and 168 after surgery
Spectral domain optical coherence tomography (SD-OCT) of the macula
Status of the macula (mac-on versus mac-off)
Time frame: Day 1, 7, 28, 84, and 168 after surgery
Adverse events
Adverse events including conjunctival injection, subconjunctival hemorrhage, and corneal verticillata, eye irritation, reticular edema of the cornea, hypotony
Time frame: Day 1, 7, 28, 84, and 168 after surgery
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