NCT04401982

Brief Summary

The goal of this clinical trial is to compare participants treated with latanoprost to those treated with Rocklatan (netarsudil/latanoprost) to determine whether the addition of netarsudil results in greater improvements in episcleral venous blood flow in adults with glaucoma or ocular hypertension. Episcleral venous blood flow will be measured using erythrocyte-mediated angiography (EMA) and laser speckle contrast imaging (LSCI). The main questions this study aims to answer are:

  • Does Rocklatan produce greater increases in episcleral venous blood flow than latanoprost alone?
  • Can EMA and LSCI reliably detect changes in episcleral venous blood flow following treatment with these medications? Participants will:
  • Be randomized to receive either latanoprost or Rocklatan
  • Undergo imaging of the episcleral veins using EMA and LSCI before, during, and after treatment, and
  • Complete study visits that include standard ophthalmic examinations and intraocular pressure measurements. Hypothesis: The investigators hypothesize that latanoprost, which primarily increases uveoscleral outflow, will not significantly affect the distal episcleral circulation. In contrast, Rocklatan, through its netarsudil component, is expected to produce measurable increases in episcleral venous flow.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
8mo left

Started Jul 2026

Shorter than P25 for phase_4

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jul 2026Mar 2027

First Submitted

Initial submission to the registry

May 20, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 26, 2020

Completed
6.1 years until next milestone

Study Start

First participant enrolled

July 2, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2027

Last Updated

July 2, 2026

Status Verified

June 1, 2026

Enrollment Period

9 months

First QC Date

May 20, 2020

Last Update Submit

June 30, 2026

Conditions

Ocular HypertensionSuspect Glaucoma

Outcome Measures

Primary Outcomes (2)

  • Change in Episcleral Venous Blood Flow Measured by Erythrocyte-Mediated Angiography (EMA)

    Change in episcleral venous blood flow following treatment with latanoprost 0.005% and/or Rocklatan, as measured by erythrocyte-mediated angiography (EMA). EMA will be used to quantify episcleral blood flow through measurement of erythrocyte velocity and vessel diameter, allowing calculation of absolute blood flow at baseline (T0), after 28-35 days of latanoprost treatment (T1), and after an additional 14-28 days of either continued latanoprost or switching to Rocklatan (T2).

    Baseline (T0), 28-35 days from baseline (T1), 14-28 days from T1 (T2)

  • Change in Retinal Arteriolar and Venular Blood Flow Measured by Erythrocyte-Mediated Angiography (EMA)

    Change in retinal blood flow within arterioles and venules less than 100 microns in diameter following treatment with latanoprost 0.005% and/or Rocklatan, as measured by erythrocyte-mediated angiography (EMA). EMA will be used to quantify retinal blood flow through measurement of erythrocyte velocity and vessel diameter at baseline (T0), after 28-35 days of latanoprost treatment (T1), and after an additional 14-28 days of either continued latanoprost or switching to Rocklatan (T2).

    Baseline (T0), 28-35 days from baseline (T1), 14-28 days from T1 (T2)

Study Arms (1)

Glaucoma Suspect

EXPERIMENTAL

Individuals with a diagnosis of glaucoma suspect

Drug: Rocklatan (Netarsudil 0.02%/ latanoprost 0.005)Drug: Latanoprost (0.005%)

Interventions

Rocklatan (Netarsudil 0.02%/ latanoprost 0.005)DRUG

Rocklatan (Netarsudil 0.02%/ latanoprost 0.005) one drop nightly for 14-28 days, if randomized to Rocklatan after 28-35 days on Latanoprost.

Glaucoma Suspect
Latanoprost (0.005%)DRUG

Latanoprost 0.005% one drop nightly for 28-35 days, then 14-28 days if randomized to continue on latanoprost.

Glaucoma Suspect

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients are at least 18 years of age.
  • Patients must have ocular hypertension or be a glaucoma suspect.
  • Patient must not have used any IOP-lowering medication (topical or systemic) within the past 6 months
  • Patients must have open angles on gonioscopy.
  • 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:

  • Participation in other investigational studies, unless such participation does not involve the administration of any drugs or agents that could impact the results of this study or have an effect on episcleral flow, as determined by the Investigator.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

University Physicians Inc.

Baltimore, Maryland, 21201, United States

RECRUITING

UM Faculty Physicians, Inc. | 5900 Waterloo Crossing

Columbia, Maryland, 21045, United States

RECRUITING

Maryland Eye Consultants and Surgeons

Silver Spring, Maryland, 20902, United States

RECRUITING

MeSH Terms

Conditions

Ocular Hypertension

Interventions

netarsudilLatanoprost

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Osamah Saeedi, MD

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Osamah Saeedi, MD

CONTACT

(410) 328-5929osaeedi@som.umaryland.edu

Zaina L Maharoof, BS

CONTACT

(667) 214-1463eyeresearch@som.umaryland.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
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

July 2, 2026

Primary Completion (Estimated)

March 17, 2027

Study Completion (Estimated)

March 17, 2027

Last Updated

July 2, 2026

Record last verified: 2026-06

Locations

US(4)