About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients > 18 years old
Patients presenting for primary rhegmatogenous retinal detachment repair within 28 days of symptom onset
Patients undergoing vitrectomy or vitrectomy with scleral buckle
Disqualifiers
Patient unable to give consent
Patient unable to follow-up
Prior history of retinal detachment incisional surgery in presenting eye
Prior history of open globe injury to presenting eye
Trial design
Parallel
Treatments tested in this trial
Netarsudil Ophthalmic
DrugTopical administration of Netarsudil
Treatment groups
Trial outcomes
Primary outcomes
The 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)
Serious adverse events
Unexpected serious adverse events
Secondary outcomes
Number of operations within 3 months
Total number of operation during the first 3 months after surgery
Final attachment status at last follow-up
Status of the retina (attached versus detached) at last follow-up visit
Visual acuity
Best-corrected visual acuity measured using Snellen chart
Spectral domain optical coherence tomography (SD-OCT) of the macula
Status of the macula (mac-on versus mac-off)
Sponsors and contacts
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Massachusetts Eye and Ear Infirmary
Lead sponsor
Massachusetts General Hospital
Sponsor institution