xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06033703</url>
    </required_header>
    <id_info>
      <org_study_id>2022P000152</org_study_id>
      <nct_id>NCT06033703</nct_id>
    </id_info>
    <brief_title>Topical Netarsudil for the Prevention of Proliferative Vitreoretinopathy in Patients With Retinal Detachment</brief_title>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Massachusetts Eye and Ear Infirmary</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Massachusetts Eye and Ear Infirmary</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study has two main objectives. The first objective is to study the pharmacokinetics of&#xD;
        topical netarsudil administration in the posterior segment of the eye, where netarsudil must&#xD;
        exert its effect in order to prevent formation of tractional membranes.&#xD;
  &#xD;
        The second objective is to assess the safety profile of topical netarsudil in the pre- and&#xD;
        post-operative periods. A secondary objective of the study is to begin to assess signs of&#xD;
        efficacy in preventing formation of tractional membranes post-operatively.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an open-label, randomized study that will test the safety and pharmacokinetics of&#xD;
        topical netarsudil at a dose frequency of once-daily in two cohorts of patients: those with&#xD;
        primary rhegmatogenous detachments, and those with established proliferative&#xD;
        vitreoretinopathy. The intervention will be topical application of Netarsudil from time of&#xD;
        diagnosis of retinal detachment to 16 weeks post-operatively.&#xD;
  &#xD;
        Patients will be randomized to one of the following groups:&#xD;
  &#xD;
          -  The primary rhegmatogenous detachment cohort: A total of 24 study subjects (24 eyes)&#xD;
             will be stratified by their lens status (12 phakic versus 12 pseudophakic). All patients&#xD;
             will receive once per day dosing of netarsudil.&#xD;
  &#xD;
          -  The proliferative vitreoretinopathy cohort: A total of 24 study subjects (24 eyes) will&#xD;
             be stratified by their lens status (12 phakic versus 12 pseudophakic). All patients will&#xD;
             receive once per day dosing of netarsudil.&#xD;
  &#xD;
        After surgery, patients will continue on either once per day dosing of Netarsudil.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
    <phase>Phase 1/Phase 2</phase>
    <study_type>Interventional</study_type>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Parallel Assignment</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The concentration of netarsudil in the vitreous to assess its pharmacokinetic properties.</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Netarsudil concentration in the posterior segment of the eye, using High-performance liquid chromatography (HPLC)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serious adverse events</measure>
      <time_frame>Day 1, 7, 28, 56, 84, 126, and 168 after surgery</time_frame>
      <description>Unexpected serious adverse events</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of operations within 3 months</measure>
      <time_frame>Day 84 after surgery</time_frame>
      <description>Total number of operation during the first 3 months after surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Final attachment status at last follow-up</measure>
      <time_frame>Day 168 after surgery</time_frame>
      <description>Status of the retina (attached versus detached) at last follow-up visit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual acuity</measure>
      <time_frame>Day 1, 7, 28, 56, 84, 126, and 168 after surgery</time_frame>
      <description>Best-corrected visual acuity measured using Snellen chart</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Spectral domain optical coherence tomography (SD-OCT) of the macula</measure>
      <time_frame>Day 1, 7, 28, 56, 84, 126, and 168 after surgery</time_frame>
      <description>Status of the macula (mac-on versus mac-off)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events</measure>
      <time_frame>Day 1, 7, 28, 56, 84, 126, and 168 after surgery</time_frame>
      <description>Adverse events including conjunctival injection, subconjunctival hemorrhage, and corneal verticillata, eye irritation, reticular edema of the cornea, hypotony</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Rhegmatogenous Retinal Detachment</condition>
    <condition>Proliferative Vitreoretinopathy</condition>
    <arm_group>
      <arm_group_label>Primary retinal detachment, Phakic group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Phakic patients with primary rhegmatogenous retinal detachment repair within 7 days of symptom onset, undergoing vitrectomy or vitrectomy with scleral buckle will be included.&#xD;
  Patients will receive topical Netarsudil ophthalmic solution 0.02%: once per day, from time of diagnosis of retinal detachment to 16 weeks post-operatively.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Primary retinal detachment, Pseudophakic group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Pseudophakic patients with primary rhegmatogenous retinal detachment repair within 7 days of symptom onset, undergoing vitrectomy or vitrectomy with scleral buckle will be included.&#xD;
  Patients will receive topical Netarsudil ophthalmic solution 0.02%: once per day, from time of diagnosis of retinal detachment to 16 weeks post-operatively.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Secondary retinal detachment, Phakic group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.&#xD;
  Patients will receive topical Netarsudil ophthalmic solution 0.02%: once per day, from time of diagnosis of retinal detachment to 16 weeks post-operatively.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Secondary retinal detachment, Pseudophakic group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.&#xD;
  Patients will receive topical Netarsudil ophthalmic solution 0.02%: once per day, from time of diagnosis of retinal detachment to 16 weeks post-operatively.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Netarsudil Ophthalmic</intervention_name>
      <description>Topical administration of Netarsudil</description>
      <arm_group_label>Primary retinal detachment, Phakic group</arm_group_label>
      <arm_group_label>Primary retinal detachment, Pseudophakic group</arm_group_label>
      <arm_group_label>Secondary retinal detachment, Phakic group</arm_group_label>
      <arm_group_label>Secondary retinal detachment, Pseudophakic group</arm_group_label>
      <other_name>Rhopressa</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          The primary rhegmatogenous detachment cohort will have the following selection criteria:&#xD;
  &#xD;
          Inclusion criteria:&#xD;
  &#xD;
            -  Patients &gt; 18 years old&#xD;
  &#xD;
            -  Patients presenting for primary rhegmatogenous retinal detachment repair within 7 days&#xD;
               of symptom onset&#xD;
  &#xD;
            -  Patients undergoing vitrectomy or vitrectomy with scleral buckle&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Patient unable to give consent&#xD;
  &#xD;
            -  Patient unable to follow-up&#xD;
  &#xD;
            -  Prior history of retinal detachment incisional surgery in presenting eye&#xD;
  &#xD;
            -  Prior history of open globe injury to presenting eye&#xD;
  &#xD;
            -  Prior history of glaucoma surgery to presenting eye I.e., Status post trabeculectomy,&#xD;
               Ahmed tube placement, minimally invasive glaucoma surgery, actively on glaucoma&#xD;
               medication&#xD;
  &#xD;
            -  Prior history of corneal disease, or history of corneal edema&#xD;
  &#xD;
            -  Patient already on topical netarsudil in presenting eye&#xD;
  &#xD;
            -  Patient without natural lens or intraocular lens implant (I.e., aphakic patients)&#xD;
  &#xD;
            -  Patients with intraocular pressure &lt;8mm Hg in operative eye&#xD;
  &#xD;
            -  Active or chronic or recurrent uncontrolled ocular or systemic disease&#xD;
  &#xD;
            -  Active or history of chronic or recurrent inflammatory eye disease&#xD;
  &#xD;
            -  Diagnosis of proliferative diabetic retinopathy&#xD;
  &#xD;
            -  Signs of ocular infection at presentation in either eye&#xD;
  &#xD;
            -  Known or suspected sensitivity or allergy to any of the medications used in the&#xD;
               operation or postoperatively&#xD;
  &#xD;
            -  Inability to use/ apply topical eye drops&#xD;
  &#xD;
          The proliferative vitreoretinopathy cohort will have the following selection criteria:&#xD;
  &#xD;
          Inclusion criteria:&#xD;
  &#xD;
            -  Patients &gt; 18 years old&#xD;
  &#xD;
            -  Patient presenting with retinal detachment due with proliferative vitreoretinopathy&#xD;
               (grade C or higher) or retinal detachment associated with open globe trauma&#xD;
  &#xD;
            -  Patients undergoing vitrectomy or vitrectomy with scleral buckle&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Patient unable to give consent&#xD;
  &#xD;
            -  Patient unable to follow-up&#xD;
  &#xD;
            -  Prior history of glaucoma surgery to presenting eye I.e., Status post trabeculectomy,&#xD;
               Ahmed tube placement, minimally invasive glaucoma surgery&#xD;
  &#xD;
            -  Patient already on topical netarsudil in presenting eye&#xD;
  &#xD;
            -  Patients with intraocular pressure &lt;8mm Hg in operative eye&#xD;
  &#xD;
            -  Active or chronic or recurrent uncontrolled ocular or systemic disease&#xD;
  &#xD;
            -  Active or history of chronic or recurrent inflammatory eye disease&#xD;
  &#xD;
            -  Diagnosis of severe nonproliferative or proliferative diabetic retinopathy or&#xD;
               vasoproliferative disease in operative eye&#xD;
  &#xD;
            -  Signs of ocular infection at presentation in either eye&#xD;
  &#xD;
            -  Known or suspected sensitivity or allergy to any of the medications used in the&#xD;
               operation or postoperatively&#xD;
  &#xD;
            -  Inability to use/ apply topical eye drops&#xD;
  &#xD;
            -  No Light Perception vision in operative eye&#xD;
  &#xD;
            -  Failure to achieve intraoperative reattachment&#xD;
  &#xD;
            -  Patient with silicone oil instilled in operative eye at time of presentation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Leo Kim, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Massachusetts Eye and Ear</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Leo Kim, MD, PhD</last_name>
      <phone>6175237900</phone>
      <email>Leo_Kim@meei.harvard.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Center for Clinical Research Operations (CCRO)</last_name>
      <phone>6175736060</phone>
    </overall_contact_backup>
    <reference>
      <citation>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.</citation>
      <PMID>28609185</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>32826769</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>33758139</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>30653957</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>29199013</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>30318038</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>32289295</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>33369939</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>September 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 9, 2023</last_update_submitted>
    <last_update_submitted_qc>September 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Massachusetts Eye and Ear Infirmary</investigator_affiliation>
      <investigator_full_name>Leo Am Kim, M.D.</investigator_full_name>
      <investigator_title>Assistant Professor of Ophthalmology</investigator_title>
    </responsible_party>
    <keyword>Vitrectomy</keyword>
    <keyword>Netarsudil</keyword>
    <keyword>Pharmacokinetics</keyword>
    <keyword>Safety</keyword>
    <keyword>Efficacy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Retinal Detachment</mesh_term>
      <mesh_term>Vitreoretinopathy, Proliferative</mesh_term>
      <mesh_term>Dissociative Disorders</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06033703
  org study id: 2022P000152
  nct id: NCT06033703
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  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.
  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 either once per day dosing of Netarsudil.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: The concentration of netarsudil in the vitreous to assess its pharmacokinetic properties.
  time frame: Through study completion, an average of 1 year
  description: Netarsudil concentration in the posterior segment of the eye, using High-performance liquid chromatography (HPLC)
  measure: Serious adverse events
  time frame: Day 1, 7, 28, 56, 84, 126, and 168 after surgery
  description: Unexpected serious adverse events
  measure: Number of operations within 3 months
  time frame: Day 84 after surgery
  description: Total number of operation during the first 3 months after surgery
  measure: Final attachment status at last follow-up
  time frame: Day 168 after surgery
  description: Status of the retina (attached versus detached) at last follow-up visit
  measure: Visual acuity
  time frame: Day 1, 7, 28, 56, 84, 126, and 168 after surgery
  description: Best-corrected visual acuity measured using Snellen chart
  measure: Spectral domain optical coherence tomography (SD-OCT) of the macula
  time frame: Day 1, 7, 28, 56, 84, 126, and 168 after surgery
  description: Status of the macula (mac-on versus mac-off)
  measure: Adverse events
  time frame: Day 1, 7, 28, 56, 84, 126, and 168 after surgery
  description: Adverse events including conjunctival injection, subconjunctival hemorrhage, and corneal verticillata, eye irritation, reticular edema of the cornea, hypotony
  arm group label: Primary retinal detachment, Phakic group
  arm group type: Experimental
  description: 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.
  arm group label: Primary retinal detachment, Pseudophakic group
  arm group type: Experimental
  description: 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.
  arm group label: Secondary retinal detachment, Phakic group
  arm group type: Experimental
  description: 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.
  arm group label: Secondary retinal detachment, Pseudophakic group
  arm group type: Experimental
  description: 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.
  intervention type: Drug
  intervention name: Netarsudil Ophthalmic
  description: Topical administration of Netarsudil
  arm group label: Primary retinal detachment, Phakic group
  arm group label: Primary retinal detachment, Pseudophakic group
  arm group label: Secondary retinal detachment, Phakic group
  arm group label: Secondary retinal detachment, Pseudophakic group
  other name: Rhopressa
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Leo Kim, MD, PhD
  role: Principal Investigator
  affiliation: Massachusetts Eye and Ear
  last name: Leo Kim, MD, PhD
  phone: 6175237900
  email: Leo_Kim@meei.harvard.edu
  last name: Center for Clinical Research Operations (CCRO)
  phone: 6175736060
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  responsible party type: Principal Investigator
  investigator affiliation: Massachusetts Eye and Ear Infirmary
  investigator full name: Leo Am Kim, M.D.
  investigator title: Assistant Professor of Ophthalmology
  mesh term: Retinal Detachment
  mesh term: Vitreoretinopathy, Proliferative
  mesh term: Dissociative Disorders