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Measuring the Effects of Netarsudil, Latanoprost, and Combination Therapy on Episcleral and Retinal Blood Flow in Ocular Hypertension and Glaucoma Suspects

RecruitingPhase 4Ages 18 Years - anyAllUniversity of Maryland, Baltimore
NCT04401982 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to compare participants treated with latanoprost to those treated with Rocklatan (netarsudil/latanoprost) to determine whether the addition of netarsudil results in greater improvements in episcleral venous blood flow in adults with glaucoma or ocular hypertension. Episcleral venous blood flow will be measured using erythrocyte-mediated angiography (EMA) and laser speckle contrast imaging (LSCI). The main questions this study aims to answer are: * Does Rocklatan produce greater increases in episcleral venous blood flow than latanoprost alone? * Can EMA and LSCI reliably detect changes in episcleral venous blood flow following treatment with these medications? Participants will: * Be randomized to receive either latanoprost or Rocklatan * Undergo imaging of the episcleral veins using EMA and LSCI before, during, and after treatment, and * Complete st

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📋 Eligibility rules (as published)
Inclusion: * Patients are at least 18 years of age. * Patients must have ocular hypertension or be a glaucoma suspect. * Patient must not have used any IOP-lowering medication (topical or systemic) within the past 6 months * Patients must have open angles on gonioscopy. * All patients will have at least one recorded visual field examination within 6 months of enrollment in the study. Visual fields will be assessed using the Hodapp-Andersen-Parish criteria. Exclusion: * Participation in other investigational studies, unless such participation does not involve the administration of any drugs or agents that could impact the results of this study or have an effect on episcleral flow, as determined by the Investigator. * Prior intraocular surgery other than uncomplicated cataract surgery. * Allergy or history of adverse reaction to ICG, shellfish, or Iodine. * Significant liver disease or uremia. * Secondary glaucoma including exfoliation glaucoma, pigmentary glaucoma, or history of acute angle closure. * Moderate or severe visual field deficits as per Hodapp-Anderson-Parish criteria. * Any condition precluding imaging including reliable visual fields, disc photography, or use of study treatments including media opacity or tilted optic disk * Pregnant or nursing patients.
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What it tests

  • Rocklatan (Netarsudil 0.02%/ latanoprost 0.005)
  • Latanoprost (0.005%)
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Where

4 sites
University of Maryland Medical Center
Baltimore, United States
University Physicians Inc.
Baltimore, United States
UM Faculty Physicians, Inc. | 5900 Waterloo Crossing
Columbia, United States
Maryland Eye Consultants and Surgeons
Silver Spring, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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