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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Maryland, Baltimore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Glaucoma SuspectExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline (T0), 28-35 days from baseline (T1), 14-28 days from T1 (T2)
2

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).

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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