Measuring the Effects of Netarsudil, Latanoprost, and Combination Therapy on Episcleral and Retinal Blood Flow in Ocular Hypertension and Glaucoma Suspects

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT04401982
Phase
PHASE4
Status
Recruiting
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Conditions

  • Ocular Hypertension
  • Suspect Glaucoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
May 26, 2020
Start date
Jul 2, 2026
Status verified
Jun 2026
Primary completion
Mar 17, 2027
Completion
Mar 17, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Glaucoma Suspect
    Individuals with a diagnosis of glaucoma suspect

Primary Outcome Measure

Change in Episcleral Venous Blood Flow Measured by Erythrocyte-Mediated Angiography (EMA) [ Time Frame: Baseline (T0), 28-35 days from baseline (T1), 14-28 days from T1 (T2) ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of Maryland Medical CenterBaltimoreMaryland21201
Osamah Saeedi
[email protected]
University Physicians Inc.BaltimoreMaryland21201
Alfred L Vinnett, BS
[email protected]
(667) 214-1232
UM Faculty Physicians, Inc. | 5900 Waterloo CrossingColumbiaMaryland21045
Osamah Saeedi, MD
410-328-3865
Osamah Saeedi, MD (PRINCIPAL_INVESTIGATOR)
Maryland Eye Consultants and SurgeonsSilver SpringMaryland20902
Osamah Saeedi
Osamah Saeedi, MD (PRINCIPAL_INVESTIGATOR)

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University of Maryland Medical Center· Baltimore, MDUniversity Physicians Inc.· Baltimore, MDUM Faculty Physicians, Inc. | 5900 Waterloo Crossing· Columbia, MDMaryland Eye Consultants and Surgeons· Silver Spring, MD

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