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

NCT06033703 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 2022P000152
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

Vitrectomy; Netarsudil; Pharmacokinetics; Safety; Efficacy

Outcome Measures

Primary Outcomes (2)

• The concentration of netarsudil in the vitreous to assess its pharmacokinetic properties.

  Netarsudil concentration in the posterior segment of the eye, using High-performance liquid chromatography (HPLC)

  Through study completion, an average of 1 year

• Serious adverse events

  Unexpected serious adverse events

  Day 1, 7, 28, 84, and 168 after surgery

Secondary Outcomes (5)

• Number of operations within 3 months

  Day 84 after surgery

• Final attachment status at last follow-up

  Day 168 after surgery

• Visual acuity

  Day 1, 7, 28, 84, and 168 after surgery

• Spectral domain optical coherence tomography (SD-OCT) of the macula

  Day 1, 7, 28, 84, and 168 after surgery

• Adverse events

  Day 1, 7, 28, 84, and 168 after surgery

Study Arms (4)

Primary retinal detachment, Phakic group

EXPERIMENTAL

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.

Drug: Netarsudil Ophthalmic

Primary retinal detachment, Pseudophakic group

EXPERIMENTAL

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.

Drug: Netarsudil Ophthalmic

Secondary retinal detachment, Phakic group

EXPERIMENTAL

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.

Drug: Netarsudil Ophthalmic

Secondary retinal detachment, Pseudophakic group

EXPERIMENTAL

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.

Drug: Netarsudil Ophthalmic

Interventions

Netarsudil Ophthalmic DRUG

Topical administration of Netarsudil

Also known as: Rhopressa

Primary retinal detachment, Phakic group; Primary retinal detachment, Pseudophakic group; Secondary retinal detachment, Phakic group; Secondary retinal detachment, Pseudophakic group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

Study Sites (1)

Mass Eye and Ear

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (8)

• Lin CW, Sherman B, Moore LA, Laethem CL, Lu DW, Pattabiraman PP, Rao PV, deLong MA, Kopczynski CC. Discovery and Preclinical Development of Netarsudil, a Novel Ocular Hypotensive Agent for the Treatment of Glaucoma. J Ocul Pharmacol Ther. 2018 Jan/Feb;34(1-2):40-51. doi: 10.1089/jop.2017.0023. Epub 2017 Jun 13.

  PMID: 28609185 BACKGROUND

• 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.

  PMID: 32826769 BACKGROUND

• 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.

  PMID: 33758139 BACKGROUND

• 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.

  PMID: 30653957 BACKGROUND

• 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.

  PMID: 29199013 BACKGROUND

• 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.

  PMID: 30318038 BACKGROUND

• 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.

  PMID: 32289295 BACKGROUND

• 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.

  PMID: 33369939 BACKGROUND

MeSH Terms

Conditions

Vitreoretinopathy, Proliferative

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Leo Kim, MD, PhD

  Massachusetts Eye and Ear

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leo Kim, MD, PhD

CONTACT

6175237900; Leo_Kim@meei.harvard.edu

Center for Clinical Research Operations (CCRO)

CONTACT

6175736060

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Ophthalmology

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: September 13, 2023
• Study Start: January 14, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)