Recruiting

Phase 1

Phase 2

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

Sponsor:

Massachusetts Eye and Ear Infirmary

Code:

NCT06033703

Conditions

Rhegmatogenous Retinal Detachment

Proliferative Vitreoretinopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Netarsudil Ophthalmic

Study Details

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 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.

Conditions

Rhegmatogenous Retinal Detachment

Proliferative Vitreoretinopathy

Study ID

NCT06033703

Start date

Jan 14, 2025

Status verified date

Oct, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Primary retinal detachment, Phakic group

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.

experimental: Primary retinal detachment, Pseudophakic group

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.

experimental: Secondary retinal detachment, Phakic group

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.

experimental: Secondary retinal detachment, Pseudophakic group

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.

Interventions

Netarsudil Ophthalmic

Topical administration of Netarsudil

Primary outcome measure

The concentration of netarsudil in the vitreous to assess its pharmacokinetic properties. [ Time Frame: Through study completion, an average of 1 year ]
Serious adverse events [ Time Frame: Day 1, 7, 28, 84, and 168 after surgery ]

Central Contacts and Locations

Central contacts

Leo Kim, MD, PhD

6175237900 Leo_Kim@meei.harvard.edu

Center for Clinical Research Operations (CCRO)

6175736060

Locations

Mass Eye and Ear

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

Massachusetts Eye and Ear Infirmary

Last update posted

Oct 28, 2025

Last verified

Oct, 2025

Keywords

Vitrectomy
Netarsudil
Pharmacokinetics
Safety
Efficacy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts Eye and Ear Infirmary on 2025-10-28.