Status:
RECRUITING
Topical Netarsudil for the Prevention of Proliferative Vitreoretinopathy in Patients With Retinal Detachment
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Conditions:
Rhegmatogenous Retinal Detachment
Proliferative Vitreoretinopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 effec...
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 rhegmatoge...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
Key Trial Info
Start Date :
January 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06033703
Start Date
January 14 2025
End Date
December 1 2026
Last Update
October 28 2025
Active Locations (1)
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1
Mass Eye and Ear
Boston, Massachusetts, United States, 02114