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Rhegmatogenous Retinal DetachmentPhase 1/2NCT06033703

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

A Phase 1/2 study testing Netarsudil Ophthalmic in people with Rhegmatogenous Retinal Detachment and Proliferative Vitreoretinopathy, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Netarsudil Ophthalmic
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
14 Jan 2025to Dec 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 29Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Leo Kim, MD, PhD contact

6175237900

Leo_Kim@meei.harvard.edu

Center for Clinical Research Operations (CCRO) contact

6175736060

United States1 site, 1 recruiting
  • Mass Eye and Ear

    Boston, Massachusetts, 02114

    Leo A Kim, MD. PhD

    Recruiting

Other trials in United States

About this study

Official title: 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 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.

Read the 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.

Being tested
Netarsudil Ophthalmic
Keywords
Vitrectomy, Netarsudil, Pharmacokinetics, Safety, Efficacy
Medical subject headings
Vitreoretinopathy, Proliferative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Netarsudil OphthalmicDrug

    Also called Rhopressa

    Topical administration of Netarsudil

Study groups in NCT06033703
Study groupRoleWhat they receive
Primary retinal detachment, Phakic groupExperimentalPhakic 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.
Receives: Drug: Netarsudil Ophthalmic
Primary retinal detachment, Pseudophakic groupExperimentalPseudophakic 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.
Receives: Drug: Netarsudil Ophthalmic
Secondary retinal detachment, Phakic groupExperimentalPhakic 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.
Receives: Drug: Netarsudil Ophthalmic
Secondary retinal detachment, Pseudophakic groupExperimentalPseudophakic 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.
Receives: Drug: Netarsudil Ophthalmic

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Through study completion, an average of 1 year

  2. Serious adverse events

    Unexpected serious adverse events

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

Secondary outcomes (5)
  1. Number of operations within 3 months

    Total number of operation during the first 3 months after surgery

    Measured: Day 84 after surgery

  2. Final attachment status at last follow-up

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

    Measured: Day 168 after surgery

  3. Visual acuity

    Best-corrected visual acuity measured using Snellen chart

    Measured: 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)

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

  5. Adverse events

    Adverse events including conjunctival injection, subconjunctival hemorrhage, and corneal verticillata, eye irritation, reticular edema of the cornea, hypotony

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2023
  2. Study start14 Jan 2025
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06033703
Sponsor's protocol ID
2022P000152
Status last verified
Oct 2026
First submitted
17 Aug 2023
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28609185
  • 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.

    PubMed 32826769
  • 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.

    PubMed 33758139
  • 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.

    PubMed 30653957
  • 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.

    PubMed 29199013
  • 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.

    PubMed 30318038
  • 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.

    PubMed 32289295
  • 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.

    PubMed 33369939

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Netarsudil Ophthalmic in people with Rhegmatogenous Retinal Detachment and Proliferative Vitreoretinopathy, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Leo Kim, MD, PhD (6175237900, Leo_Kim@meei.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The concentration of netarsudil in the vitreous to assess its pharmacokinetic properties. (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06033703, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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