Ocular HypertensionPhase 4NCT04401982
Measuring the Effects of Netarsudil, Latanoprost, and Combination Therapy on Episcleral and Retinal Blood Flow in Ocular Hypertension and Glaucoma Suspects
A Phase 4 study testing Rocklatan (Netarsudil 0.02%/ latanoprost 0.005) and Latanoprost (0.005%) in people with Ocular Hypertension and Suspect Glaucoma, run by University of Maryland, Baltimore at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Hypertension, Suspect Glaucoma
- What is being tested?
- Rocklatan (Netarsudil 0.02%/ latanoprost 0.005) and Latanoprost (0.005%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- 2 Jul 2026to 17 Mar 2027
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
University of Maryland Medical Center
Baltimore, Maryland, 21201
Osamah Saeedi, osaeedi@som.umaryland.edu
- Recruiting
University Physicians Inc.
Baltimore, Maryland, 21201
Alfred L Vinnett, BS, (667) 214-1232, eyeresearch@som.umaryland.edu
- Recruiting
UM Faculty Physicians, Inc. | 5900 Waterloo Crossing
Columbia, Maryland, 21045
Osamah Saeedi, MD, 410-328-3865
Osamah Saeedi, MD
- Recruiting
Maryland Eye Consultants and Surgeons
Silver Spring, Maryland, 20902
Osamah Saeedi
Osamah Saeedi, MD
About this study
Official title: Measuring the Effects of Netarsudil, Latanoprost, and Combination Therapy on Episcleral and Retinal Blood Flow in Ocular Hypertension and Glaucoma Suspects Using Erythrocyte Mediated Angiography In Vivo
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:
Read more
- 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.
Read the detailed description
Glaucoma is a leading cause of irreversible blindness worldwide, and lowering intraocular pressure (IOP) remains the primary strategy for slowing disease progression. While many glaucoma medications reduce IOP by increasing aqueous humor outflow or decreasing its production, the effects of these therapies on the distal conventional outflow pathway-particularly the episcleral venous circulation-are not well understood. Previous studies using erythrocyte-mediated angiography (EMA)-a novel imaging technique capable of directly quantifying episcleral venous blood flow in vivo-demonstrated that netarsudil (Rhopressa) significantly increases episcleral venous flow while lowering IOP, supporting episcleral blood flow as a biomarker of distal outflow function.
This study will build on those findings by comparing the effects of latanoprost and Rocklatan (netarsudil/latanoprost) on episcleral venous blood flow using both EMA and laser speckle contrast imaging (LSCI), a newer, less invasive imaging modality. Investigators will evaluate whether the addition of netarsudil to latanoprost produces measurable improvements in episcleral venous flow beyond those achieved with latanoprost alone. By improving the understanding of how these medications influence the distal outflow pathway, this study may help explain the superior IOP-lowering efficacy of Rocklatan and support the development of noninvasive imaging methods for assessing treatment response in glaucoma.
Building on these findings, this study will compare the effects of latanoprost and Rocklatan (netarsudil/latanoprost) on episcleral venous blood flow using EMA and laser speckle contrast imaging (LSCI), a newer, noninvasive imaging modality. Latanoprost, a first-line prostaglandin analogue, primarily lowers IOP by increasing uveoscleral outflow and is not expected to substantially alter distal episcleral circulation. In contrast, Rocklatan combines the effects of latanoprost with netarsudil, which enhances conventional outflow and reduces episcleral venous pressure, and is therefore hypothesized to produce measurable increases in episcleral venous blood flow. By directly comparing these therapies, the study aims to assess whether Rocklatan enhances distal outflow as compared to latanoprost, correlate changes in episcleral flow with IOP reductions to evaluate the role of episcleral modulation as a driver of Rocklatan's enhanced clinical efficacy, and redefine how researchers and clinicians evaluate IOP-lowering therapies by targeting the actual vascular response of the distal outflow system.
Ultimately, this work has the potential to clarify the mechanism underlying Rocklatan's superior efficacy, establish episcleral venous flow as a novel biomarker for pharmacologic response, and support further development of therapies that leverage distal outflow enhancement.
- Conditions
- Ocular Hypertension, Suspect Glaucoma
- Being tested
- Rocklatan (Netarsudil 0.02%/ latanoprost 0.005), Latanoprost (0.005%)
- Medical subject headings
- Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocklatan (Netarsudil 0.02%/ latanoprost 0.005)Drug
Rocklatan (Netarsudil 0.02%/ latanoprost 0.005) one drop nightly for 14-28 days, if randomized to Rocklatan after 28-35 days on Latanoprost.
Latanoprost (0.005%)Drug
Latanoprost 0.005% one drop nightly for 28-35 days, then 14-28 days if randomized to continue on latanoprost.
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma Suspect | Experimental | Individuals with a diagnosis of glaucoma suspect Receives: Drug: Rocklatan (Netarsudil 0.02%/ latanoprost 0.005); Drug: Latanoprost (0.005%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Episcleral Venous Blood Flow Measured by Erythrocyte-Mediated Angiography (EMA)
Change in episcleral venous blood flow following treatment with latanoprost 0.005% and/or Rocklatan, as measured by erythrocyte-mediated angiography (EMA). EMA will be used to quantify episcleral blood flow through measurement of erythrocyte velocity and vessel diameter, allowing calculation of absolute blood flow at baseline (T0), after 28-35 days of latanoprost treatment (T1), and after an additional 14-28 days of either continued latanoprost or switching to Rocklatan (T2).
Measured: Baseline (T0), 28-35 days from baseline (T1), 14-28 days from T1 (T2)
Change in Retinal Arteriolar and Venular Blood Flow Measured by Erythrocyte-Mediated Angiography (EMA)
Change in retinal blood flow within arterioles and venules less than 100 microns in diameter following treatment with latanoprost 0.005% and/or Rocklatan, as measured by erythrocyte-mediated angiography (EMA). EMA will be used to quantify retinal blood flow through measurement of erythrocyte velocity and vessel diameter at baseline (T0), after 28-35 days of latanoprost treatment (T1), and after an additional 14-28 days of either continued latanoprost or switching to Rocklatan (T2).
Measured: Baseline (T0), 28-35 days from baseline (T1), 14-28 days from T1 (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start2 Jul 2026 (estimated)
- Primary completion17 Mar 2027 (estimated)
- Study completion17 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular HypertensionStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, Osamah Saeedi, University of Maryland, Baltimore
- Investigators
- Osamah Saeedi, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401982
- Sponsor's protocol ID
- HP-00086248
- Status last verified
- Jun 2026
- First submitted
- 20 May 2020
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Effects of Netarsudil, Latanoprost, and Combination Therapy on Episcleral and Retinal Blood Flow in Ocular Hypertension and Glaucoma Suspects Using Erythrocyte Mediated Angiography In Vivo
- ClinicalTrials.gov ID
- NCT04401982
- Acronym / sponsor ID
- HP-00086248
- Conditions
- Ocular Hypertension, Suspect Glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 2 Jul 2026 (estimated)
- Primary completion
- 17 Mar 2027 (estimated)
- Study completion
- 17 Mar 2027 (estimated)
- First posted
- 26 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Glaucoma is a leading cause of irreversible blindness worldwide, and lowering intraocular pressure (IOP) remains the primary strategy for slowing disease progression. While many glaucoma medications reduce IOP by increasing aqueous humor outflow or decreasing its production, the effects of these therapies on the distal conventional outflow pathway-particularly the episcleral venous circulation-are not well understood. Previous studies using erythrocyte-mediated angiography (EMA)-a novel imaging technique capable of directly quantifying episcleral venous blood flow in vivo-demonstrated that netarsudil (Rhopressa) significantly increases episcleral venous flow while lowering IOP, supporting episcleral blood flow as a biomarker of distal outflow function.
This study will build on those findings by comparing the effects of latanoprost and Rocklatan (netarsudil/latanoprost) on episcleral venous blood flow using both EMA and laser speckle contrast imaging (LSCI), a newer, less invasive imaging modality. Investigators will evaluate whether the addition of netarsudil to latanoprost produces measurable improvements in episcleral venous flow beyond those achieved with latanoprost alone. By improving the understanding of how these medications influence the distal outflow pathway, this study may help explain the superior IOP-lowering efficacy of Rocklatan and support the development of noninvasive imaging methods for assessing treatment response in glaucoma.
Building on these findings, this study will compare the effects of latanoprost and Rocklatan (netarsudil/latanoprost) on episcleral venous blood flow using EMA and laser speckle contrast imaging (LSCI), a newer, noninvasive imaging modality. Latanoprost, a first-line prostaglandin analogue, primarily lowers IOP by increasing uveoscleral outflow and is not expected to substantially alter distal episcleral circulation. In contrast, Rocklatan combines the effects of latanoprost with netarsudil, which enhances conventional outflow and reduces episcleral venous pressure, and is therefore hypothesized to produce measurable increases in episcleral venous blood flow. By directly comparing these therapies, the study aims to assess whether Rocklatan enhances distal outflow as compared to latanoprost, correlate changes in episcleral flow with IOP reductions to evaluate the role of episcleral modulation as a driver of Rocklatan's enhanced clinical efficacy, and redefine how researchers and clinicians evaluate IOP-lowering therapies by targeting the actual vascular response of the distal outflow system.
Ultimately, this work has the potential to clarify the mechanism underlying Rocklatan's superior efficacy, establish episcleral venous flow as a novel biomarker for pharmacologic response, and support further development of therapies that leverage distal outflow enhancement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glaucoma Suspect | Experimental | Drug: Rocklatan (Netarsudil 0.02%/ latanoprost 0.005), Drug: Latanoprost (0.005%)Individuals with a diagnosis of glaucoma suspect |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rocklatan (Netarsudil 0.02%/ latanoprost 0.005)Rocklatan (Netarsudil 0.02%/ latanoprost 0.005) one drop nightly for 14-28 days, if randomized to Rocklatan after 28-35 days on Latanoprost. | Drug | Glaucoma Suspect |
| Latanoprost (0.005%)Latanoprost 0.005% one drop nightly for 28-35 days, then 14-28 days if randomized to continue on latanoprost. | Drug | Glaucoma Suspect |
Primary outcome
Change in Episcleral Venous Blood Flow Measured by Erythrocyte-Mediated Angiography (EMA)
Time frame: Baseline (T0), 28-35 days from baseline (T1), 14-28 days from T1 (T2)
Change in episcleral venous blood flow following treatment with latanoprost 0.005% and/or Rocklatan, as measured by erythrocyte-mediated angiography (EMA). EMA will be used to quantify episcleral blood flow through measurement of erythrocyte velocity and vessel diameter, allowing calculation of absolute blood flow at baseline (T0), after 28-35 days of latanoprost treatment (T1), and after an additional 14-28 days of either continued latanoprost or switching to Rocklatan (T2).
Change in Retinal Arteriolar and Venular Blood Flow Measured by Erythrocyte-Mediated Angiography (EMA)
Time frame: Baseline (T0), 28-35 days from baseline (T1), 14-28 days from T1 (T2)
Change in retinal blood flow within arterioles and venules less than 100 microns in diameter following treatment with latanoprost 0.005% and/or Rocklatan, as measured by erythrocyte-mediated angiography (EMA). EMA will be used to quantify retinal blood flow through measurement of erythrocyte velocity and vessel diameter at baseline (T0), after 28-35 days of latanoprost treatment (T1), and after an additional 14-28 days of either continued latanoprost or switching to Rocklatan (T2).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Osamah Saeedi, MD principal investigator
University of Maryland, Baltimore
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rocklatan (Netarsudil 0.02%/ latanoprost 0.005) and Latanoprost (0.005%) in people with Ocular Hypertension and Suspect Glaucoma, run by University of Maryland, Baltimore at 4 sites 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 5 inclusion and 8 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 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Osamah Saeedi, MD ((410) 328-5929, osaeedi@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Episcleral Venous Blood Flow Measured by Erythrocyte-Mediated Angiography (EMA) (time frame: Baseline (T0), 28-35 days from baseline (T1), 14-28 days from T1 (T2)). 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?
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 2 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.