RecruitingPhase 1Phase 2NCT06033703

Topical Netarsudil for the Prevention of Proliferative Vitreoretinopathy in Patients With Retinal Detachment

Topical Netarsudil for the Prevention of Proliferative Vitreoretinopathy in Patients With Primary Rhegmatogenous Detachments and Retinal Detachment Due to Proliferative Vitreoretinopathy or Open-Globe Injury: A Phase I/II Clinical Trial

Sponsor

Massachusetts Eye and Ear Infirmary

Enrollment

48 participants

Start Date

Jan 14, 2025

Study Type

INTERVENTIONAL

Conditions

rhegmatogenous retinal detachment Proliferative Vitreoretinopathy

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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
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 Criteria29

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:
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