Imaging the Effects of Netarsudil (Rhopressa) on the Trabecular Meshwork in Glaucoma and Ocular Hypertension
Adaptive Optics Gonioscopy In Vivo Imaging of the Effects of Rhopressa on the Trabecular Meshwork in Patients With Ocular Hypertension or Glaucoma
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Brett J King, OD
- Número de teléfono: (812) 855-1344
- Correo electrónico: kingbrj@iu.edu
Ubicaciones de estudio
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Indiana
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Bloomington, Indiana, Estados Unidos, 47405
- Reclutamiento
- Indiana Universtiy School of Optometry
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: 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.
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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.
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Comparador de placebos: 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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Trabecular Meshwork Lamellae Spacing
Periodo de tiempo: Baseline to 14-21 days after initiation of treatment
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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.
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Baseline to 14-21 days after initiation of treatment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Trabecular Meshwork Height
Periodo de tiempo: Baseline to 14-21 days after initiation of treatment
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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.
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Baseline to 14-21 days after initiation of treatment
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Change in Trabecular Meshwork Width
Periodo de tiempo: Baseline to 14-21 days after initiation of treatment
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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.
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Baseline to 14-21 days after initiation of treatment
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Schlemm's Canal Diameter
Periodo de tiempo: Baseline to 14-21 days after initiation of treatment
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Mean change in Schlemm's canal cross-sectional diameter measured using AS-OCT and OCT gonioscopy.
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Baseline to 14-21 days after initiation of treatment
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Trabecular Meshwork Endothelial Cell Counts
Periodo de tiempo: Baseline and 14-21 days after initiation of treatment
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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.
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Baseline and 14-21 days after initiation of treatment
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 31537
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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