Topical Netarsudil for the Prevention of Proliferative Vitreoretinopathy in Patients With Retinal… (NCT06033703) | Clinical Trial Compass
RecruitingPhase 1/2
Topical Netarsudil for the Prevention of Proliferative Vitreoretinopathy in Patients With Retinal Detachment
United States48 participantsStarted 2025-01-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The concentration of netarsudil in the vitreous to assess its pharmacokinetic properties.
Timeframe: Through study completion, an average of 1 year
2
Serious adverse events
Timeframe: Day 1, 7, 28, 84, and 168 after surgery