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Imaging the Effects of Netarsudil (Rhopressa) on the Trabecular Meshwork in Glaucoma and Ocular Hypertension

9. juni 2026 opdateret af: Brett King, Indiana University

Adaptive Optics Gonioscopy In Vivo Imaging of the Effects of Rhopressa on the Trabecular Meshwork in Patients With Ocular Hypertension or Glaucoma

This study evaluates the effects of netarsudil (Rhopressa) on the trabecular meshwork in subjects with ocular hypertension or open-angle glaucoma. Participants will be randomized to receive either netarsudil or placebo (artificial tears). High-resolution imaging using adaptive optics gonioscopy, anterior segment optical coherence tomography (AS-OCT), and OCT gonioscopy will be performed at baseline and after approximately 14 days of treatment. The primary objective is to assess changes in trabecular meshwork lamellae spacing, with secondary measures including trabecular meshwork height, width, and Schlemm's canal diameter.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Glaucoma is a leading cause of irreversible blindness and is characterized by progressive optic neuropathy. A major modifiable risk factor is elevated intraocular pressure, which is largely regulated by aqueous humor outflow through the trabecular meshwork. Netarsudil (Rhopressa), a Rho kinase inhibitor, lowers intraocular pressure in part by increasing trabecular outflow and has been shown in preclinical studies to induce structural changes in trabecular meshwork cells and tissues. However, in vivo human data evaluating these effects remain limited.

This prospective, randomized, single-masked study will enroll approximately 50 subjects with ocular hypertension or open-angle glaucoma. Participants will be randomized in a 2:1 ratio to receive either netarsudil ophthalmic solution or placebo (artificial tears). Subjects may undergo a washout period if currently treated with glaucoma medications.

Imaging will be performed using adaptive optics gonioscopy to visualize trabecular meshwork microstructure, as well as anterior segment optical coherence tomography (AS-OCT) and OCT gonioscopy to assess clinically relevant anatomical parameters. Imaging will occur at baseline and after approximately 14-21 days of treatment.

The primary outcome is the change in trabecular meshwork lamellae spacing. Secondary outcomes include changes in trabecular meshwork height and width. Exploratory outcomes include Schlemm's canal diameter and trabecular meshwork endothelial cell counts. These measurements aim to provide in vivo evidence of the structural effects of netarsudil on the aqueous outflow pathway and improve understanding of its mechanism of action in humans.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Brett J King, OD
  • Telefonnummer: (812) 855-1344
  • E-mail: kingbrj@iu.edu

Studiesteder

  • Forenede Stater
    • Indiana
      • Bloomington, Indiana, Forenede Stater, 47405
        • Rekruttering
        • Indiana Universtiy School of Optometry

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Adults aged 18 years or older
  • Diagnosis of ocular hypertension or open-angle glaucoma
  • Eye examination within the past year
  • For glaucoma subjects: structural (optic nerve and/or retinal nerve fiber layer) and functional (visual field) findings consistent with glaucoma
  • Best-corrected visual acuity of 20/100 or better
  • Open anterior chamber angle as confirmed by gonioscopy and anterior segment optical coherence tomography (AS-OCT)
  • Intraocular pressure between 18 and 34 mmHg (treatment-naïve or after washout, if applicable)

Exclusion Criteria:

  • Known intolerance to netarsudil ophthalmic solution
  • Corneal scarring or active corneal disease that would interfere with imaging
  • Inability to tolerate gonioscopy procedures
  • Females of childbearing potential who are not using effective contraception or are not sterile
  • Any condition that, in the opinion of the investigator, would place the subject at increased risk or interfere with study completion

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Netarsudil (Rhopressa)
Participants will receive netarsudil ophthalmic solution administered as one drop in the study eye once daily in the evening for approximately 14 days.
Medicin: Netarsudil Ophthalmic Solution (Rhopressa)
Netarsudil ophthalmic solution is an FDA-approved Rho kinase inhibitor indicated for the treatment of ocular hypertension and open-angle glaucoma. In this study, it will be administered once daily in the evening for approximately 14 days.
Placebo komparator: Placebo (Artificial Tears)
Participants will receive artificial tears administered as one drop in the study eye once daily in the evening for approximately 14 days.
Andet: Artificial Tears (AT)
Artificial tears will be used as a placebo control and administered once daily in the evening for approximately 14 days. These drops are not expected to lower intraocular pressure or alter trabecular meshwork structure.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Trabecular Meshwork Lamellae Spacing
Tidsramme: Baseline to 14-21 days after initiation of treatment
Mean change in trabecular meshwork lamellae spacing measured using adaptive optics gonioscopy. Measurements will be obtained from baseline (after washout if applicable) and compared to measurements after treatment.
Baseline to 14-21 days after initiation of treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Trabecular Meshwork Height
Tidsramme: Baseline to 14-21 days after initiation of treatment
Mean change in trabecular meshwork height measured using anterior segment optical coherence tomography (AS-OCT) and OCT gonioscopy. Height is defined as the distance between the scleral spur and Schwalbe's line.
Baseline to 14-21 days after initiation of treatment
Change in Trabecular Meshwork Width
Tidsramme: Baseline to 14-21 days after initiation of treatment
Mean change in trabecular meshwork width measured using AS-OCT and OCT gonioscopy. Width is defined as the thickness of the trabecular meshwork from the inner wall of Schlemm's canal to the inner surface of the trabecular meshwork.
Baseline to 14-21 days after initiation of treatment

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Schlemm's Canal Diameter
Tidsramme: Baseline to 14-21 days after initiation of treatment
Mean change in Schlemm's canal cross-sectional diameter measured using AS-OCT and OCT gonioscopy.
Baseline to 14-21 days after initiation of treatment
Trabecular Meshwork Endothelial Cell Counts
Tidsramme: Baseline and 14-21 days after initiation of treatment
Trabecular meshwork endothelial cell counts measured using adaptive optics gonioscopy. Cell counts will be assessed at baseline and may be compared between groups and correlated with intraocular pressure changes.
Baseline and 14-21 days after initiation of treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Indiana University

Samarbejdspartnere

Alcon Research

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2028

Studieafslutning (Anslået)

1. juni 2028

Datoer for studieregistrering

Først indsendt

8. maj 2026

Først indsendt, der opfyldte QC-kriterier

8. maj 2026

Først opslået (Faktiske)

14. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 31537

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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Kliniske forsøg med Okulær hypertension

Kliniske forsøg med Netarsudil Ophthalmic Solution (Rhopressa)

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