Proliferative Vitreoretinopathy, Rhegmatogenous Retinal Detachment
Conditions
Keywords
Vitrectomy, Netarsudil, Pharmacokinetics, Safety, Efficacy
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 once per day dosing of Netarsudil for a total of 16 weeks post-op.
Interventions
Topical administration of Netarsudil
Sponsors
Massachusetts Eye and Ear Infirmary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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 trabeculectomy, Ahmed tube placement, minimally invasive glaucoma surgery, actively on glaucoma medication * Prior history of corneal disease, or history of corneal edema * Patient already on topical netarsudil in presenting eye * Patient without natural lens or intraocular lens implant (I.e., aphakic patients) * Patients with intraocular pressure \<8mm Hg in operative eye * Active or chronic or recurrent uncontrolled ocular or systemic disease * Active or history of chronic or recurrent inflammatory eye disease * Diagnosis of proliferative diabetic retinopathy * Signs of ocular infection at presentation in either eye * Known or suspected sensitivity or allergy to any of the medications used in the operation or postoperatively * Inability to use/ apply topical eye drops The proliferative vitreoretinopathy cohort will have the following selection criteria: Inclusion criteria: * Patients \> 18 years old * Patient presenting with retinal detachment due with proliferative vitreoretinopathy (grade C or higher) or retinal detachment associated with open globe trauma * Patients undergoing vitrectomy or vitrectomy with scleral buckle
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Serious adverse events | Day 1, 7, 28, 84, and 168 after surgery | Unexpected serious adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity | Day 1, 7, 28, 84, and 168 after surgery | Best-corrected visual acuity measured using Snellen chart |
| Number of operations within 3 months | Day 84 after surgery | Total number of operation during the first 3 months after surgery |
| Adverse events | Day 1, 7, 28, 84, and 168 after surgery | Adverse events including conjunctival injection, subconjunctival hemorrhage, and corneal verticillata, eye irritation, reticular edema of the cornea, hypotony |
| Spectral domain optical coherence tomography (SD-OCT) of the macula | Day 1, 7, 28, 84, 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 |
Countries
United States
Contacts
Primary ContactLeo Kim, MD, PhD
Backup ContactCenter for Clinical Research Operations (CCRO)
Outcome results
None listed