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

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: Completed
• Conditions: Ocular Hypertension; Suspect Glaucoma
• Intervention / Treatment: Drug: Netarsudil ophthalmic solution 0.02% one drop nightly for 1-2 weeks

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: Observational
• Enrollment (Actual): 10

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in episcleral venous blood flow with Rhopressa	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	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

• Sponsor: University of Maryland, Baltimore
• Collaborators: Aerie Pharmaceuticals
• Investigators: Principal Investigator: Osamah Saeedi, MD, University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Actual): February 22, 2022
• Study Completion (Actual): February 22, 2022

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Ocular Hypertension; Hypertension; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID 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