Rocklatan vs latanoprost for ocular blood flow in ocular hypertension and suspected glaucoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, phase 4 trial compares Rocklatan (netarsudil/latanoprost) with latanoprost alone in adults with ocular hypertension or suspected glaucoma. The primary goal is to see if adding netarsudil increases episcleral venous blood flow, as measured by erythrocyte-mediated angiography and laser speckle contrast imaging. Participants will undergo baseline and follow-up imaging of the episcleral veins, along with standard eye exams and intraocular pressure measurements, to assess distal outflow effects and treatment response. The study builds on prior data suggesting netarsudil can raise episcleral venous flow while lowering IOP, and it also evaluates the reliability of EMA and LSCI as imaging biomarkers. Enrollment includes specific eligibility criteria and safety monitoring across study visits.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Maryland Medical Center
  Baltimore, Maryland, United States Recruiting
• University Physicians Inc.
  Baltimore, Maryland, United States Recruiting
• UM Faculty Physicians, Inc. | 5900 Waterloo Crossing
  Columbia, Maryland, United States Recruiting
• Maryland Eye Consultants and Surgeons
  Silver Spring, Maryland, United States Recruiting

Study contacts

• Principal investigator: Osamah Saeedi, MD — University of Maryland, Baltimore
• Study coordinator: Osamah Saeedi, MD
• Email: osaeedi@som.umaryland.edu
• Phone: (410) 328-5929

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.