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

26 oktober 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

13

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Brett J King, OD, FAAO, Dipl AAO (Glaucoma)
  • Telefonnummer: (812) 855-1344
  • E-post: kingbrj@iu.edu

Studera Kontakt Backup

  • Namn: Kaitlyn M Asher, CCRC, BS
  • Telefonnummer: 2194067487
  • E-post: kamasher@iu.edu

Studieorter

  • Förenta staterna
    • Indiana
      • Bloomington, Indiana, Förenta staterna, 47405
        • Rekrytering
        • Indiana University School Of Optometry
        • Kontakt:
          • Kaitlyn M Asher, CCRC, BS
          • Telefonnummer: 2194067487
          • E-post: kamasher@iu.edu
        • Kontakt:
          • Brett J King, OD, FAAO, Dipl AAO(Glaucoma)
          • Telefonnummer: (812) 855-1344
          • E-post: kingbrj@iu.edu
        • Underutredare:
          • Donald T Miller, PhD
        • Underutredare:
          • Matthew Keller, OD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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).
Läkemedel: 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.

Andra namn:
  • Rhopressa
Läkemedel: 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.

Andra namn:
  • Timoptic
Experimentell: 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).
Läkemedel: 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.

Andra namn:
  • Rhopressa
Läkemedel: 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.

Andra namn:
  • Timoptic

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in GC soma density (cells/mm²)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Changes in GC soma counts (number of cells)
Tidsram: 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))
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Brett King

Samarbetspartners

Alcon Research

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

1 januari 2028

Avslutad studie (Beräknad)

1 januari 2028

Studieregistreringsdatum

Först inskickad

22 september 2026

Först inskickad som uppfyllde QC-kriterierna

22 september 2026

Första postat (Faktisk)

29 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

28 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 32936
  • 17426-BJKing (Annan identifierare: Sterling IRB)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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