Measuring the Effects of Rhopressa on Episcleral and Retinal Blood Flow in Ocular Hypertension and Glaucoma Suspects

March 24, 2022 updated by: Osamah Saeedi, University of Maryland, Baltimore

Measuring the Effects of Rhopressa on Episcleral and Retinal Blood Flow in Ocular Hypertension and Glaucoma Suspects Using Erythrocyte Mediated Angiography In Vivo

Rhopressa effectively lowers intra-ocular pressure by improving conventional outflow and decreasing episcleral venous pressure. While this may result in improved episcleral venous flow, current methods to quantify episcleral blood flow in vivo are rudimentary and unable to accurately and precisely determine flow. Proof that Rhopressa effectively increases episcleral venous flow would differentiate it from other medications. Furthermore, this evidence could galvanize interest in the use of Rhopressa after popular Minimally Invasive Glaucoma Surgery (MIGS) procedures. In future studies, MIGS procedures could be used to improve the proximal outflow pathway, and Rhopressa to enhance distal outflow.

Specific Aim:

To determine the effect of Rhopressa on episcleral venous outflow and retinal blood flow in a cohort of treatment-naïve ocular hypertensive and glaucoma suspect patients.

Hypothesis:

Rhopressa increases episcleral venous flow and retinal blood flow from baseline at both 1 hour and 1 week after initiation of therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Need/Relevance:

Rhopressa effectively lowers intra-ocular pressure by improving conventional outflow and decreasing episcleral venous pressure. While this may result in improved episcleral venous flow, current methods to quantify episcleral blood flow in vivo are rudimentary and unable to accurately and precisely determine flow. Proof that Rhopressa effectively increases episcleral venous flow would differentiate it from other medications. Furthermore, this evidence could galvanize interest in the use of Rhopressa after popular Minimally Invasive Glaucoma Surgery (MIGS) procedures. In future studies, MIGS procedures could be used to improve the proximal outflow pathway, and Rhopressa to enhance distal outflow.

Purpose/Aim:

The investigators have developed a technology to accurately and precisely determine episcleral and retinal blood flow in human subjects using ICG labeled erythrocytes via a technique the investigators have coined as Erythrocyte Mediated Angiography (EMA). The investigators propose conducting a pilot study to show the effect of Rhopressa on both improving episcleral blood flow as well as studying its effect on retinal blood flow. With lower intraocular pressure, and correspondingly higher ocular perfusion pressure, Rhopressa may also improve retinal blood flow.

Specific Aim:

To determine the effect of Rhopressa on episcleral venous outflow and retinal blood flow in a cohort of treatment-naïve ocular hypertensive and glaucoma suspect patients.

Hypothesis:

Rhopressa increases episcleral venous flow and retinal blood flow from baseline at both 1 hour and 1 week after initiation of therapy.

To test this hypothesis, the investigators will measure and compare episcleral venous and retinal blood flow at baseline, 1 hour after Rhopressa instillation and 1 week after initiation of Rhopressa.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
      • Baltimore, Maryland, United States, 21201
        • University Physicians Inc.
      • Columbia, Maryland, United States, 21045
        • UM Faculty Physicians, Inc. | 5900 Waterloo Crossing
      • Silver Spring, Maryland, United States, 20902
        • Maryland Eye Consultants and Surgeons

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will be recruited from the optometry service and the glaucoma division at the University of Maryland School of Medicine, Department of Ophthalmology. We will establish a cohort of 10 patients comprised of treatment-naïve ocular hypertensive and glaucoma suspect patients with the following eligibility criteria.

Description

Inclusion Criteria:

  • Patients at least 18 years of age.
  • Patients must have ocular hypertension or be a glaucoma suspect.
  • Patients must be treatment naïve without alternative study treatments or previous history of using topical IOP lowering agents.
  • Patients must have an IOP of 24-30 mm Hg in the affected eye.
  • Patients must have open angles on gonioscopy.
  • Patients must be willing and able to comply with the protocol including providing informed consent.
  • 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 Criteria:

  • 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.
  • Greater than 6 diopters of refractive error.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Glaucoma Suspect
Individuals with a diagnosis of glaucoma suspect
Drug: Netarsudil ophthalmic solution 0.02% one drop nightly for 1-2 weeks
Netarsudil ophthalmic solution 0.02% one drop nightly for 1-2 weeks will be administered
Other Names:
  • Rhopressa

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in episcleral venous blood flow with Rhopressa
Time Frame: 1 year
Change in episcleral venous blood flow with Rhopressa as measured using erythrocyte mediated angiography flowmetry.
1 year
Change in retinal blood flow in arterioles and venules less than 100 microns with Rhopressa
Time Frame: 1 year
Change in retinal blood flow in arterioles and venules less than 100 microns with Rhopressa. Retinal blood flow will be measured with erythrocyte mediated angiography flowmetry
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Maryland, Baltimore

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aerie Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Osamah Saeedi, MD, University of Maryland, Baltimore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 22, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HP-00086248

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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