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

Mass Eye and Ear

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Proliferative Vitreoretinopathy; Rhegmatogenous Retinal Detachment

Treatments: Drug: Netarsudil Ophthalmic

Study type: Interventional

Funder types: Other

Identifiers

NCT06033703

2022P000152

Details and patient eligibility

About

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.

Full 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 rhegmatogenous detachments, and those with established proliferative vitreoretinopathy. The intervention will be topical application of Netarsudil from time of diagnosis of retinal detachment to 16 weeks post-operatively.

Patients will be randomized to one of the following groups:

• The primary rhegmatogenous detachment cohort: A total of 24 study subjects (24 eyes) will be stratified by their lens status (12 phakic versus 12 pseudophakic). All patients will receive once per day dosing of netarsudil.
• The proliferative vitreoretinopathy cohort: A total of 24 study subjects (24 eyes) will be stratified by their lens status (12 phakic versus 12 pseudophakic). All patients will receive once per day dosing of netarsudil.

After surgery, patients will continue on once per day dosing of Netarsudil for a total of 16 weeks post-op.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

Primary retinal detachment, Phakic group

Experimental group

Description:

Phakic patients with primary rhegmatogenous retinal detachment repair within 7 days of symptom onset, undergoing vitrectomy or vitrectomy with scleral buckle will be included. Patients will receive topical Netarsudil ophthalmic solution 0.02%: once per day, from time of diagnosis of retinal detachment to 16 weeks post-operatively.

Treatment:

Drug: Netarsudil Ophthalmic

Primary retinal detachment, Pseudophakic group

Experimental group

Description:

Pseudophakic patients with primary rhegmatogenous retinal detachment repair within 7 days of symptom onset, undergoing vitrectomy or vitrectomy with scleral buckle will be included. Patients will receive topical Netarsudil ophthalmic solution 0.02%: once per day, from time of diagnosis of retinal detachment to 16 weeks post-operatively.

Treatment:

Drug: Netarsudil Ophthalmic

Secondary retinal detachment, Phakic group

Experimental group

Description:

Phakic patients with retinal detachment due with proliferative vitreoretinopathy (grade C or higher) or retinal detachment associated with open globe trauma, undergoing vitrectomy or vitrectomy with scleral buckle will be included. Patients will receive topical Netarsudil ophthalmic solution 0.02%: once per day, from time of diagnosis of retinal detachment to 16 weeks post-operatively.

Treatment:

Drug: Netarsudil Ophthalmic

Secondary retinal detachment, Pseudophakic group

Experimental group

Description:

Pseudophakic patients with retinal detachment due with proliferative vitreoretinopathy (grade C or higher) or retinal detachment associated with open globe trauma, undergoing vitrectomy or vitrectomy with scleral buckle will be included. Patients will receive topical Netarsudil ophthalmic solution 0.02%: once per day, from time of diagnosis of retinal detachment to 16 weeks post-operatively.

Treatment:

Drug: Netarsudil Ophthalmic