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Prevention study for Rhegmatogenous Retinal Detachment
Official title Topical Netarsudil for the Prevention of Proliferative Vitreoretinopathy in Patients With Retinal Detachment
ClinicalTrials.gov ID: NCT06033703
What this study is testing
What is Netarsudil Ophthalmic?
Netarsudil Ophthalmic is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for rhegmatogenous retinal detachment.
Also referred to as Rhopressa.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- The primary rhegmatogenous detachment cohort will have the following selection 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
You likely can't join if
- 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...
- Prior history of corneal disease, or history of corneal edema
See the full eligibility criteria
- The primary rhegmatogenous detachment cohort will have the following selection 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.