Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients

26 octobre 2026 mis à jour par: Brett King

The purpose of this study is to compare how two FDA-approved eye drops: netarsudil (Rhopressa) and timolol, protect nerve cells in the eye of adults with open-angle glaucoma. Both medications lower pressure inside the eye, but researchers want to learn if Rhopressa is more effective at slowing down or preventing the loss of retinal ganglion cells. These cells are essential for sight because they carry visual signals from the eye to the brain.

Participants in this study will complete a total of 6 study visits over 12 months:

  • Participants will spend 6 months using Rhopressa eye drops and 6 months using Timolol eye drops. The order of the two eye drops will be chosen randomly.
  • At scheduled study visits, researchers will examine participants' eyes and measure eye pressure.
  • Researchers will take detailed pictures of the back of the eye using a specialized high-resolution camera called adaptive optics optical coherence tomography (AO-OCT).
  • Participants will also complete specialized visual field testing to measure eye function.

Researchers will count and track individual nerve cells over time to determine if one medication offers better protection against cell loss than the other.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

Glaucoma is a chronic, progressive optic neuropathy characterized by functional and structural alterations, specifically the degeneration and loss of retinal ganglion cells (RGCs). Currently, the main modifiable factor for intervention is aimed at lowering intraocular pressure (IOP). While IOP reduction slows disease progression, it does not halt neurodegeneration. Rho kinase (ROCK) inhibitors have been reported to provide benefit in neurodegenerative diseases. Netarsudil ophthalmic solution (Rhopressa) is a ROCK inhibitor approved for the treatment and management of open-angle glaucoma that lowers IOP and has reported protective effects on neural tissue. However, previous attempts to illustrate true cell loss or protection using clinical instrumentation have not demonstrated an effect to date.

High-resolution retinal imaging based on adaptive optics optical coherence tomography (AO-OCT) enables direct visualization, tracking, and quantification of individual ganglion cell layer (GCL) somas in the living human eye. Leveraging the unique imaging capabilities and extraordinary sensitivity of ultra-high-speed AO-OCT, this study will test the hypothesis that treatment with netarsudil is more effective at reducing glaucomatous ganglion cell loss while producing comparable intraocular pressure reduction to that of the comparator.

This prospective, randomized, investigator-masked, cross-over pilot study will compare RGC survival rates between two treatment groups (Rhopressa and Timolol). Thirteen subjects with open-angle glaucoma will be recruited. Following a screening assessment and medication washout period based on drug class, eligible subjects are randomized 1:1 into two age-matched cohorts:

  • Cohort 1: Receives Rhopressa (one drop once at night) for 6 months, then crosses over to receive Timolol 0.25% (one drop twice a day) for 6 months.
  • Cohort 2: Receives Timolol 0.25% (one drop twice a day) for 6 months, then crosses over to receive Rhopressa (one drop once at night) for 6 months.

At Visit 2 (baseline), Visit 4 (6 months), and Visit 6 (12 months), subjects undergo imaging using the Indiana AO-OCT system along with Goldmann applanation tonometry, standard clinical OCT, and OCT-guided microperimetry (MP-3). AO-OCT imaging is performed at the same retinal regions surrounding arcuate defects to enable longitudinal cellular-level analysis. Primary and secondary endpoints evaluate differences in the rate of change of RGC soma density, individual RGC counts, and GCL thickness between treatment periods.

Type d'étude

Interventionnel

Inscription (Estimé)

13

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Brett J King, OD, FAAO, Dipl AAO (Glaucoma)
  • Numéro de téléphone: (812) 855-1344
  • E-mail: kingbrj@iu.edu

Sauvegarde des contacts de l'étude

  • Nom: Kaitlyn M Asher, CCRC, BS
  • Numéro de téléphone: 2194067487
  • E-mail: kamasher@iu.edu

Lieux d'étude

  • États-Unis
    • Indiana
      • Bloomington, Indiana, États-Unis, 47405
        • Recrutement
        • Indiana University School Of Optometry
        • Contact:
          • Kaitlyn M Asher, CCRC, BS
          • Numéro de téléphone: 2194067487
          • E-mail: kamasher@iu.edu
        • Contact:
          • Brett J King, OD, FAAO, Dipl AAO(Glaucoma)
          • Numéro de téléphone: (812) 855-1344
          • E-mail: kingbrj@iu.edu
        • Sous-enquêteur:
          • Donald T Miller, PhD
        • Sous-enquêteur:
          • Matthew Keller, OD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • All subjects will be 18 years of age or older
  • Subjects must be diagnosed with open-angle glaucoma and have had an eye exam within the past year
  • Subjects with glaucoma will have structural (optic nerve and retinal nerve fiber layer) and functional (visual field testing) defects consistent with the diagnosis of glaucoma
  • Subjects will have a corrected acuity of 20/50 or better and be able to fixate
  • Naïve to medication subjects or post washout IOP between 18 and 34 mmHg
  • Spherical equivalent from +3 diopters to -6 diopters, with a cylinder of <-3 diopters
  • Subject is willing and able to comply with the protocol requirements and to remain in the study for its full duration, including all scheduled visits and follow-up assessments

Exclusion Criteria:

  • Subjects with a known intolerance to netarsudil ophthalmic solution
  • Subjects with a known intolerance to, or contraindication for, timolol maleate
  • Any subject whom the investigator determines to be at unacceptable risk for the washout or believes is unlikely to complete the study
  • Subjects with retinal disease or optic neuropathies other than glaucoma that, in the opinion of the investigator, could confound the study assessments or outcome
  • Female subjects who are pregnant, breastfeeding, or of childbearing age who are not sterile or using an acceptable method of contraception during the study

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Rhopressa first, then Timolol

Participants will instill netarsudil 0.02% (Rhopressa) ophthalmic solution (1 drop in the study eye once daily in the evening) for the first 6 months (Months 0-6). At the Month 6 visit, participants will cross over to instill timolol maleate 0.25% ophthalmic solution (1 drop in the study eye twice daily) for the remaining 6 months (Months 6-12).
Médicament: Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA]

Netarsudil ophthalmic solution (Rhopressa) is an FDA-approved Rho kinase inhibitor indicated for the treatment of ocular hypertension and open-angle glaucoma. In this study, participants will instill 1 drop of netarsudil 0.02% ophthalmic solution in the study eye once daily in the evening for 6 months.

Autres noms:
  • Rhopressa
Médicament: Timolol Maleate 0.25% Ophthalmic Solution

Timolol maleate ophthalmic solution is an FDA-approved non-selective beta-adrenergic receptor blocking agent indicated for the treatment of ocular hypertension and open-angle glaucoma. In this study, participants will instill 1 drop of timolol maleate 0.25% ophthalmic solution in the study eye twice daily (in the morning and evening) for 6 months.

Autres noms:
  • Timoptique
Expérimental: Timolol first, then Rhopressa

Participants will instill timolol maleate 0.25% ophthalmic solution (1 drop in the study eye twice daily) for the first 6 months (Months 0-6). At the Month 6 visit, participants will cross over to instill netarsudil 0.02% (Rhopressa) ophthalmic solution (1 drop in the study eye once daily in the evening) for the remaining 6 months (Months 6-12).
Médicament: Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA]

Netarsudil ophthalmic solution (Rhopressa) is an FDA-approved Rho kinase inhibitor indicated for the treatment of ocular hypertension and open-angle glaucoma. In this study, participants will instill 1 drop of netarsudil 0.02% ophthalmic solution in the study eye once daily in the evening for 6 months.

Autres noms:
  • Rhopressa
Médicament: Timolol Maleate 0.25% Ophthalmic Solution

Timolol maleate ophthalmic solution is an FDA-approved non-selective beta-adrenergic receptor blocking agent indicated for the treatment of ocular hypertension and open-angle glaucoma. In this study, participants will instill 1 drop of timolol maleate 0.25% ophthalmic solution in the study eye twice daily (in the morning and evening) for 6 months.

Autres noms:
  • Timoptique

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in GC soma density (cells/mm²)
Délai: Baseline, 6 months, and 12 months

Change in ganglion cell (GC) soma density during treatment with timolol versus netarsudil (Rhopressa)
Baseline, 6 months, and 12 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Changes in GC soma counts (number of cells)
Délai: Baseline, 6 months, and 12 months

Changes in ganglion cell (GC) soma counts during treatment with timolol versus netarsudil (Rhopressa)
Baseline, 6 months, and 12 months
Changes in GCL thickness (micrometers (µm))
Délai: Baseline, 6 months, and 12 months

Changes in ganglion cell layer (GCL) thickness during treatment with timolol versus netarsudil (Rhopressa)
Baseline, 6 months, and 12 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Brett King

Collaborateurs

Alcon Research

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 octobre 2026

Achèvement primaire (Estimé)

1 janvier 2028

Achèvement de l'étude (Estimé)

1 janvier 2028

Dates d'inscription aux études

Première soumission

22 septembre 2026

Première soumission répondant aux critères de contrôle qualité

22 septembre 2026

Première publication (Réel)

29 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 32936
  • 17426-BJKing (Autre identifiant: Sterling IRB)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner