Measuring the Effects of Netarsudil, Latanoprost, and Combination Therapy on Episcleral and Retin… (NCT04401982) | Clinical Trial Compass
RecruitingPhase 4
Measuring the Effects of Netarsudil, Latanoprost, and Combination Therapy on Episcleral and Retinal Blood Flow in Ocular Hypertension and Glaucoma Suspects
United States50 participantsStarted 2026-07-02
Plain-language summary
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 study visits that include standard ophthalmic examinations and intraocular pressure measurements.
Hypothesis: The investigators hypothesize that latanoprost, which primarily increases uveoscleral outflow, will not significantly affect the distal episcleral circulation. In contrast, Rocklatan, through its netarsudil component, is expected to produce measurable increases in episcleral venous flow.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Episcleral Venous Blood Flow Measured by Erythrocyte-Mediated Angiography (EMA)
Timeframe: Baseline (T0), 28-35 days from baseline (T1), 14-28 days from T1 (T2)
2
Change in Retinal Arteriolar and Venular Blood Flow Measured by Erythrocyte-Mediated Angiography (EMA)
Timeframe: Baseline (T0), 28-35 days from baseline (T1), 14-28 days from T1 (T2)