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

NCT ID: NCT06033703

Last Updated: 2025-10-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-14
• Study Completion Date: 2026-12-31

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.

Detailed 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.

Conditions

Rhegmatogenous Retinal Detachment; Proliferative Vitreoretinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Netarsudil Ophthalmic

Intervention Type: DRUG

Topical administration of Netarsudil

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.

Group Type: EXPERIMENTAL

Netarsudil Ophthalmic

Intervention Type: DRUG

Topical administration of Netarsudil

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.

Group Type: EXPERIMENTAL

Netarsudil Ophthalmic

Intervention Type: DRUG

Topical administration of Netarsudil

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.

Group Type: EXPERIMENTAL

Netarsudil Ophthalmic

Intervention Type: DRUG

Topical administration of Netarsudil

Interventions

Netarsudil Ophthalmic

Topical administration of Netarsudil

Intervention Type: DRUG

Other Intervention Names

Rhopressa

Eligibility 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

• 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 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:

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role: lead

Responsible Party

Leo Am Kim, M.D.

Assistant Professor of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leo Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Eye and Ear

Locations

Mass Eye and Ear

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Leo Kim, MD, PhD

Role: CONTACT

Leo_Kim@meei.harvard.edu

6175237900

Center for Clinical Research Operations (CCRO)

Role: CONTACT

6175736060

Facility Contacts

Leo A Kim, MD. PhD

Role: primary

References

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Reference Type: BACKGROUND

PMID: 28609185 (View on PubMed)

Singh IP, Fechtner RD, Myers JS, Kim T, Usner DW, McKee H, Sheng H, Lewis RA, Heah T, Kopczynski CC. Pooled Efficacy and Safety Profile of Netarsudil Ophthalmic Solution 0.02% in Patients With Open-angle Glaucoma or Ocular Hypertension. J Glaucoma. 2020 Oct;29(10):878-884. doi: 10.1097/IJG.0000000000001634.

Reference Type: BACKGROUND

PMID: 32826769 (View on PubMed)

Davies E, Jurkunas U, Pineda R 2nd. Pilot Study of Corneal Clearance With the Use of a Rho-Kinase Inhibitor After Descemetorhexis Without Endothelial Keratoplasty for Fuchs Endothelial Corneal Dystrophy. Cornea. 2021 Jul 1;40(7):899-902. doi: 10.1097/ICO.0000000000002691.

Reference Type: BACKGROUND

PMID: 33758139 (View on PubMed)

Kahook MY, Serle JB, Mah FS, Kim T, Raizman MB, Heah T, Ramirez-Davis N, Kopczynski CC, Usner DW, Novack GD; ROCKET-2 Study Group. Long-term Safety and Ocular Hypotensive Efficacy Evaluation of Netarsudil Ophthalmic Solution: Rho Kinase Elevated IOP Treatment Trial (ROCKET-2). Am J Ophthalmol. 2019 Apr;200:130-137. doi: 10.1016/j.ajo.2019.01.003. Epub 2019 Jan 15.

Reference Type: BACKGROUND

PMID: 30653957 (View on PubMed)

Serle JB, Katz LJ, McLaurin E, Heah T, Ramirez-Davis N, Usner DW, Novack GD, Kopczynski CC; ROCKET-1 and ROCKET-2 Study Groups. Two Phase 3 Clinical Trials Comparing the Safety and Efficacy of Netarsudil to Timolol in Patients With Elevated Intraocular Pressure: Rho Kinase Elevated IOP Treatment Trial 1 and 2 (ROCKET-1 and ROCKET-2). Am J Ophthalmol. 2018 Feb;186:116-127. doi: 10.1016/j.ajo.2017.11.019. Epub 2017 Dec 1.

Reference Type: BACKGROUND

PMID: 29199013 (View on PubMed)

Fernandez MM. Reticular Epithelial Edema in Edematous Corneas Treated with Netarsudil. Ophthalmology. 2018 Nov;125(11):1709. doi: 10.1016/j.ophtha.2018.08.004. No abstract available.

Reference Type: BACKGROUND

PMID: 30318038 (View on PubMed)

Wisely CE, Liu KC, Gupta D, Carlson AN, Asrani SG, Kim T. Reticular Bullous Epithelial Edema in Corneas Treated with Netarsudil: A Case Series. Am J Ophthalmol. 2020 Sep;217:20-26. doi: 10.1016/j.ajo.2020.04.002. Epub 2020 Apr 11.

Reference Type: BACKGROUND

PMID: 32289295 (View on PubMed)

LoBue SA, Moustafa GA, Vu A, Amin M, Nguyen T, Goyal H. Transient Reticular Cystic Corneal Epithelial Edema With Topical Netarsudil: A Case Series and Review. Cornea. 2021 Aug 1;40(8):1048-1054. doi: 10.1097/ICO.0000000000002621.

Reference Type: BACKGROUND

PMID: 33369939 (View on PubMed)

Other Identifiers

2022P000152

Identifier Type: -

Identifier Source: org_study_id