Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrett King
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA]
DrugNetarsudil 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.
Timolol Maleate 0.25% Ophthalmic Solution
DrugTimolol 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.
Treatment groups
13 Participants
are divided into 2 treatment groupsGroup A: Rhopressa first, then TimololExperimental treatment 2 interventions
Group B: Timolol first, then RhopressaExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in GC soma density (cells/mm²)
Change in ganglion cell (GC) soma density during treatment with timolol versus netarsudil (Rhopressa)
Time frame
Baseline, 6 months, and 12 monthsSecondary outcomes
1
Changes in GC soma counts (number of cells)
Changes in ganglion cell (GC) soma counts during treatment with timolol versus netarsudil (Rhopressa)
Time frame
Baseline, 6 months, and 12 months2
Changes in GCL thickness (micrometers (µm))
Changes in ganglion cell layer (GCL) thickness during treatment with timolol versus netarsudil (Rhopressa)
Time frame
Baseline, 6 months, and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov