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Набира участници Фаза 2/3 NCT07440225

A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)

Фаза 2/3 – комбинирано изпитване
Заболявания: Macular Degeneration Age-Related Macular Degeneration Choroidal Neovascularization Wet Macular Degeneration

Спонсор: EyeBiotech Ltd.

Налично на: БГ
Обобщение
Researchers are looking for new ways to treat neovascular age-related macular degeneration (NVAMD). Available standard (usual) treatments for NVAMD, such as aflibercept, may not work for every person. Researchers want to learn if a trial medicine called tiespectus (also called MK-8748 or EYE201) can treat NVAMD. The goal of this trial is to learn if tiespectus works as well as aflibercept to treat NVAMD.
Кой може да участва
The main inclusion criteria include but are not limited to the following: * Has treatment naive choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) including subfoveal, juxtafoveal and extrafoveal lesions or retinal angiomatous proliferations (RAP) and polypoidal choroidal vascularization (PCV) lesions in at least one eye (study eye) * The diagnosis of neovascular age-related macular degeneration (NVAMD) must have been made within 21 days prior to starting study treatment The main exclusion criteria include but are not limited to the following * Has uncontrolled blood pressure at screening * History of any prior macular laser photocoagulation in the study eye * History of uveitis in either eye * History of cataract surgery, minimally invasive glaucoma surgery, or Yttrium-Aluminium Garnet (Yag) laser capsulotomy in the study eye within 90 days before entering the study * Has uncontrolled glaucoma in the study eye * Active retinal disease other than the condition under investigation in the study eye * Has previously received anti- vascular endothelial growth factor (VEGF) therapy or other intravitreal (IVT) therapy in the study eye
Интервенции
Tiespectus
DRUG
Aflibercept
DRUG
Места на провеждане 20
САЩ (20)
Retina Research Institute of Texas (Site 010)
Abilene , Texas
Austin Retina Associates (Site 012)
Austin , Texas
Charleston Neuroscience Institute - Bluffton (Site 124)
Bluffton , South Carolina
Pacific Northwest Retina (Site 112)
Burlington , Washington
Charleston Neuroscience Institute (Site 104)
Charleston , South Carolina
Retina Group of Florida (Site 070)
Fort Lauderdale , Florida
Foundation for Vision Research (Site 073)
Grand Rapids , Michigan
Cumberland Valley Retina Consultants (Site 007)
Hagerstown , Maryland
ong Island Vitreoretinal Consultants / Vitreoretinal Consultants of NY (Site 105)
Hauppauge , New York
Retina Vitreous Surgeons of CNY, PC (Site 033)
Liverpool , New York
Piedmont Eye Center (Site 054)
Lynchburg , Virginia
Mississippi Retina Associates (Site 084)
Madison , Mississippi
Retinal Consultants Medical Group (Site 024)
Modesto , California
Texas Retina (Site 037)
Plano , Texas
Fort Lauderdale Eye Institute (Site 042)
Plantation , Florida
Retina Consultants of Southern California (Site 043)
Redlands , California
Retinal Consultants Medical Group (Site 020)
Sacramento , California
Retinal Consultants Medical Group (Site 022)
Sacramento , California
Retina Vitreous Associates of Florida (Site 049)
St. Petersburg , Florida
Retina Consultants of Texas (Site 014)
The Woodlands , Texas
Технически детайли
Статус
Набира участници
Фаза
Фаза 2/3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
50 Years
Здрави доброволци
Не
Начална дата
27.03.2026
Крайна дата
30.06.2028
Регистрационен номер
NCT07440225
Източник
clinicaltrials.gov
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