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

Ocular Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04401982
• Other study ID #: HP-00086248
• Status: Completed
• Start date: March 15, 2021
• Est. completion date: February 22, 2022

Study information

• Verified date: March 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 22, 2022
• Est. primary completion date: February 22, 2022
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension
• Suspect Glaucoma

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Aerie Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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