NCT06033703 · Massachusetts Eye and Ear Infirmary
Topical Netarsudil for the Prevention of Proliferative Vitreoretinopathy in Patients With Retinal Detachment
What this study is about
This study has two main objectives. The first objective is to study the how the drug moves through the body 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.
View original scientific description
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.
Interventions
DRUG
Netarsudil Ophthalmic
Topical administration of Netarsudil
Primary outcome measures
The concentration of netarsudil in the vitreous to assess its pharmacokinetic properties.
Time frame: 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
Time frame: Day 1, 7, 28, 84, and 168 after surgery
Unexpected serious adverse events
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 Exclusion criteria:
- Patient unable to give consent
- Patient unable to follow-up
- Prior history of glaucoma surgery to presenting eye I.e., Status post trabeculectomy, Ahmed tube placement, minimally invasive glaucoma surgery
- Patient already on topical netarsudil in presenting eye
- 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 severe nonproliferative or proliferative diabetic retinopathy or vasoproliferative disease in operative eye
- 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
- No Light Perception vision in operative eye
- Failure to achieve intraoperative reattachment
Where
- Boston, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 28, 2025 · Source of record for eligibility and locations