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Набира участници Фаза 1 NCT07425522

A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With Diabetic Macular Edema (DME)

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Diabetic Macular Edema

Спонсор: Genentech, Inc.

Налично на: БГ
Обобщение
The purpose of this study is to evaluate the safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of multiple doses of RO7823653 in participants with DME, administered by intravitreal (IVT) injection as monotherapy and co-administered with faricimab.
Кой може да участва
Inclusion Criteria: * Diagnosis of diabetes mellitus (type 1 or type 2), as defined by the World Health Organization (WHO) and/or American Diabetes Association * Glycated hemoglobin (HbA1c) \<= 12% * For study eye: Macular thickening secondary to DME involving the center of the fovea with central subfield thickness (CST) \>= 325 micrometers (µm) as measured by SD-OCT and BCVA of 65 to 35 letters Exclusion Criteria: * Currently untreated diabetes mellitus or previously untreated participants who initiated oral anti-diabetic medication or insulin within 90 days prior to Day 1 * Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required * Uncontrolled blood pressure * For Parts 1 and 2: Any history of ocular injection/implant therapy (e.g., anti-vascular endothelial growth factor agents (anti-VEGF), anti-VEGF/anti-angiopoietin-2 (Ang-2 agents), corticosteroids, device implant. * For Part 3: History of treatment with any of the following: Aflibercept 2 mg, ranibizumab, bevacizumab, or anti-VEGF biosimilars within 90 days prior to Day 1; Aflibercept 8 mg, brolucizumab, or faricimab within 120 days prior to Day 1; Triamcinolone acetonide (IVT, suprachoroidal, or periocular) within 120 days prior to Day 1; Dexamethasone intravitreal implant within 180 days prior to Day 1; Fluocinolone acetonide (FA) intravitreal implant within 3 years prior to Day 1; Device implant * History of uveitis, vitritis (grade trace or above), and/or scleritis in either eye * Active intraocular inflammation in either eye * Any previously documented or current proliferative diabetic retinopathy (PDR) in the study eye
Интервенции
RO7823653
DRUG
Faricimab
DRUG
Места на провеждане 8
САЩ (8)
Retina Research Institute of Texas
Abilene , Texas
Austin Clinical Research, LLC
Austin , Texas
Retina-Vitreous Associates Medical Group
Beverly Hills , California
Erie Retina Research, LLC - 300 State St
Erie , Pennsylvania
Piedmont Eye Center
Lynchburg , Virginia
Associated Retina Consultants - Peoria - DocTrials - PPDS
Peoria , Arizona
Retina Consultants of Texas Westover Hills Retina Center
San Antonio , Texas
Retina Vitreous Associates of Florida
St. Petersburg , Florida
Технически детайли
Статус
Набира участници
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
21.04.2026
Крайна дата
17.11.2028
Регистрационен номер
NCT07425522
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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