Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
Healthy Volunteers
NCT06033703

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

Led by Massachusetts Eye and Ear Infirmary · Updated on 2025-10-28

48

Participants Needed

1

Research Sites

98 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients older than 18 years
  • Patients presenting for primary rhegmatogenous retinal detachment repair within 28 days of symptom onset
  • Patients undergoing vitrectomy or vitrectomy with scleral buckle
  • Patients older than 18 years
  • Patients presenting with retinal detachment due to proliferative vitreoretinopathy (grade C or higher) or retinal detachment associated with open globe trauma
  • Patients undergoing vitrectomy or vitrectomy with scleral buckle
Not Eligible

You will not qualify if you...

  • 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 (e.g., trabeculectomy, Ahmed tube placement, minimally invasive glaucoma surgery) or actively on glaucoma medication
  • Prior history of corneal disease or corneal edema
  • Patient already on topical netarsudil in presenting eye
  • Patient without natural lens or intraocular lens implant (aphakic patients)
  • Patients with intraocular pressure less than 8 mm 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 or severe nonproliferative 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 medications used in the operation or postoperatively
  • Inability to use or apply topical eye drops
  • No light perception vision in operative eye
  • Failure to achieve intraoperative reattachment

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Mass Eye and Ear

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

L

Leo Kim, MD, PhD

CONTACT

C

Center for Clinical Research Operations (CCRO)

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

4

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