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

NCT04401982 | Completed DMC FDA Drug

• 1 other identifier: HP-00086248
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Ocular Hypertension; Suspect Glaucoma

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Glaucoma Suspect

Individuals with a diagnosis of glaucoma suspect

Drug: Netarsudil ophthalmic solution 0.02% one drop nightly for 1-2 weeks

Interventions

Netarsudil ophthalmic solution 0.02% one drop nightly for 1-2 weeks DRUG

Netarsudil ophthalmic solution 0.02% one drop nightly for 1-2 weeks will be administered

Also known as: Rhopressa

Glaucoma Suspect

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Aerie Pharmaceuticals: collaborator

Study Sites (4)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

University Physicians Inc.

Baltimore, Maryland, 21201, United States

Location

UM Faculty Physicians, Inc. | 5900 Waterloo Crossing

Columbia, Maryland, 21045, United States

Location

Maryland Eye Consultants and Surgeons

Silver Spring, Maryland, 20902, United States

Location

MeSH Terms

Conditions

Ocular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Osamah Saeedi, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor; Glaucoma Division Chief; Director of Clinical Research

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 26, 2020
• Study Start: March 15, 2021
• Primary Completion: February 22, 2022
• Study Completion: February 22, 2022
• Last Updated: March 28, 2022

Record last verified: 2022-03

Locations

US (4)