Topical Netarsudil for the Prevention of Proliferative Vitreoretinopathy in Patients With Primary Rhegmatogenous Detachments and Retinal Detachment Due to Proliferative Vitreoretinopathy or Open-Globe Injury: A Phase I/II Clinical Trial
Massachusetts Eye and Ear Infirmary
Summary
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
The primary rhegmatogenous detachment cohort will have the following selection criteria: Inclusion criteria: * 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 Exclusion criteria: * 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 * Prior history of glaucoma surgery to presenting eye I.e., Status post t…
Interventions
- DrugNetarsudil Ophthalmic
Topical administration of Netarsudil
Location
- Mass Eye and EarBoston, Massachusetts