Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
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.
Обзор исследования
Статус
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 4
Контакты и местонахождение
Контакты исследования
- Имя: Brett J King, OD, FAAO, Dipl AAO (Glaucoma)
- Номер телефона: (812) 855-1344
- Электронная почта: kingbrj@iu.edu
Учебное резервное копирование контактов
- Имя: Kaitlyn M Asher, CCRC, BS
- Номер телефона: 2194067487
- Электронная почта: kamasher@iu.edu
Места учебы
-
-
Indiana
-
Bloomington, Indiana, Соединенные Штаты, 47405
- Рекрутинг
- Indiana University School Of Optometry
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Контакт:
- Kaitlyn M Asher, CCRC, BS
- Номер телефона: 2194067487
- Электронная почта: kamasher@iu.edu
-
Контакт:
- Brett J King, OD, FAAO, Dipl AAO(Glaucoma)
- Номер телефона: (812) 855-1344
- Электронная почта: kingbrj@iu.edu
-
Младший исследователь:
- Donald T Miller, PhD
-
Младший исследователь:
- Matthew Keller, OD
-
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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). |
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.
Другие имена:
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.
Другие имена:
|
|
Экспериментальный: 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). |
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.
Другие имена:
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.
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in GC soma density (cells/mm²)
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Changes in GC soma counts (number of cells)
Временное ограничение: 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))
Временное ограничение: 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
|
Соавторы и исследователи
Спонсор
Соавторы
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Глазные болезни
- Глазная гипертензия
- Глаукома
- Глаукома, открытый угол
- Фармацевтические решения
- Средние соединения
- Органические химические вещества
- Гетероциклические соединения, 1-кольцо
- Гетероциклические соединения
- Фармацевтические препараты
- Тиазолы
- Азолы
- Фармакологические действия
- Химические действия и используют
- Терапевтическое использование
- Амины
- Решения
- Специальное использование химических веществ
- Спирты
- Пропаноламины
- Амино -спирты
- Пропанолы
- Тиадиазолы
- Морфолины
- Оксазины
- Офтальмологические решения
- Тимолол
- Netarsudil
Другие идентификационные номера исследования
- 32936
- 17426-BJKing (Другой идентификатор: Sterling IRB)
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
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