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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts Eye and Ear Infirmary

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Netarsudil Ophthalmic

    Drug

    Topical administration of Netarsudil

Treatment groups

48 Participants
are divided into 4 treatment groups
Group A: Primary retinal detachment, Phakic groupExperimental treatment 1 intervention
Group B: Primary retinal detachment, Pseudophakic groupExperimental treatment 1 intervention
Group C: Secondary retinal detachment, Phakic groupExperimental treatment 1 intervention
Group D: Secondary retinal detachment, Pseudophakic groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Through study completion, an average of 1 year
2

Serious adverse events

Unexpected serious adverse events

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

Secondary outcomes

1

Number of operations within 3 months

Total number of operation during the first 3 months after surgery

Time frame
Day 84 after surgery
2

Final attachment status at last follow-up

Status of the retina (attached versus detached) at last follow-up visit

Time frame
Day 168 after surgery
3

Visual acuity

Best-corrected visual acuity measured using Snellen chart

Time frame
Day 1, 7, 28, 84, and 168 after surgery
4

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

Status of the macula (mac-on versus mac-off)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts Eye and Ear Infirmary

Lead sponsor

Massachusetts General Hospital

Sponsor institution