Topical netarsudil to prevent scar-like membranes after retinal detachment surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, randomized Phase 1/2 study at a single center that examines the safety and posterior-segment pharmacokinetics of topical netarsudil applied once daily from diagnosis through 16 weeks after vitrectomy. Two parallel cohorts (primary rhegmatogenous retinal detachment and established proliferative vitreoretinopathy) will each enroll 24 eyes, stratified by lens status (phakic versus pseudophakic). Participants will receive netarsudil daily in the operative eye and undergo scheduled follow-up visits to monitor drug levels, ocular safety, and signs of tractional membrane formation. Secondary analyses will look for early signals of efficacy in preventing post-operative membrane formation and need for repeat surgery.

Why it matters

Who can join: the full rules

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

Where it's running

• Mass Eye and Ear
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Leo Kim, MD, PhD — Massachusetts Eye and Ear
• Study coordinator: Leo Kim, MD, PhD
• Email: Leo_Kim@meei.harvard.edu
• Phone: 6175237900

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.