Topical Netarsudil for the Prevention of Proliferative Vitreoretinopathy in Patients with Retinal Detachment
- Conditions
- Proliferative VitreoretinopathyRhegmatogenous Retinal Detachment
- Interventions
- Registration Number
- NCT06033703
- Lead Sponsor
- Massachusetts Eye and Ear Infirmary
- Brief 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.
- Detailed 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 (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 either once per day dosing of Netarsudil.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 48
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Primary retinal detachment, Phakic group Netarsudil Ophthalmic Phakic patients with primary rhegmatogenous retinal detachment repair within 7 days of symptom onset, undergoing vitrectomy or vitrectomy with scleral buckle will be included. Patients will receive topical Netarsudil ophthalmic solution 0.02%: once per day, from time of diagnosis of retinal detachment to 16 weeks post-operatively. Secondary retinal detachment, Phakic group Netarsudil Ophthalmic Phakic patients with retinal detachment due with proliferative vitreoretinopathy (grade C or higher) or retinal detachment associated with open globe trauma, undergoing vitrectomy or vitrectomy with scleral buckle will be included. Patients will receive topical Netarsudil ophthalmic solution 0.02%: once per day, from time of diagnosis of retinal detachment to 16 weeks post-operatively. Secondary retinal detachment, Pseudophakic group Netarsudil Ophthalmic Pseudophakic patients with retinal detachment due with proliferative vitreoretinopathy (grade C or higher) or retinal detachment associated with open globe trauma, undergoing vitrectomy or vitrectomy with scleral buckle will be included. Patients will receive topical Netarsudil ophthalmic solution 0.02%: once per day, from time of diagnosis of retinal detachment to 16 weeks post-operatively. Primary retinal detachment, Pseudophakic group Netarsudil Ophthalmic Pseudophakic patients with primary rhegmatogenous retinal detachment repair within 7 days of symptom onset, undergoing vitrectomy or vitrectomy with scleral buckle will be included. Patients will receive topical Netarsudil ophthalmic solution 0.02%: once per day, from time of diagnosis of retinal detachment to 16 weeks post-operatively.
- Primary Outcome Measures
Name Time Method Serious adverse events Day 1, 7, 28, 56, 84, 126, and 168 after surgery Unexpected serious adverse events
The concentration of netarsudil in the vitreous to assess its pharmacokinetic properties. Through study completion, an average of 1 year Netarsudil concentration in the posterior segment of the eye, using High-performance liquid chromatography (HPLC)
- Secondary Outcome Measures
Name Time Method Adverse events Day 1, 7, 28, 56, 84, 126, and 168 after surgery Adverse events including conjunctival injection, subconjunctival hemorrhage, and corneal verticillata, eye irritation, reticular edema of the cornea, hypotony
Number of operations within 3 months Day 84 after surgery Total number of operation during the first 3 months after surgery
Spectral domain optical coherence tomography (SD-OCT) of the macula Day 1, 7, 28, 56, 84, 126, and 168 after surgery Status of the macula (mac-on versus mac-off)
Final attachment status at last follow-up Day 168 after surgery Status of the retina (attached versus detached) at last follow-up visit
Visual acuity Day 1, 7, 28, 56, 84, 126, and 168 after surgery Best-corrected visual acuity measured using Snellen chart