NCT04401982

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 88 Years
• Healthy volunteers: —

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.

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.

Conditions

• Ocular Hypertension
• Suspect Glaucoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-03-15
• Primary completion: 2022-02-22
• Completion: 2022-02-22
• First posted: 2020-05-26
• Last updated: 2022-03-28

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study