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

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts Eye and Ear Infirmary

Criteria

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 7 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

• Patient with silicone oil instilled in operative eye at time of presentation