Topical netarsudil to prevent scar-like membranes after retinal detachment surgery
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
This trial will test whether once-daily netarsudil eye drops given before and after vitrectomy can help prevent proliferative vitreoretinopathy (scar tissue) in adults with retinal detachment or established PVR.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts Eye and Ear Infirmary Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06033703 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (over 18) with a recent primary rhegmatogenous retinal detachment scheduled for vitrectomy or adults with established proliferative vitreoretinopathy who can use topical drops and comply with follow-up are the intended participants.
Not a fit: Patients with prior glaucoma surgery, significant corneal disease or edema, aphakia, active uncontrolled ocular inflammation, very low intraocular pressure, current use of topical netarsudil, or those unable to adhere to follow-up are excluded and unlikely to benefit from this intervention in this protocol.
Why it matters
Potential benefit: If successful, this approach could lower the rate of postoperative proliferative vitreoretinopathy, reducing repeat surgeries and vision loss after retinal detachment repair.
How similar studies have performed: This application of netarsudil is relatively novel: rho-kinase inhibitors have preclinical support for reducing fibrotic membrane formation, but clinical data on topical netarsudil to prevent PVR are limited.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.