Идёт набор NCT07588100

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7663498 Following Intravitreal Administration in Participants With Diabetic Retinopathy

Фаза I С лечением Diabetic Retinopathy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: RO7663498.
Кому может быть актуально: Состояния в реестре: Diabetic Retinopathy. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Multicenter, Non-Randomized, Open-Label, Multiple-Ascending-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7663498 Following Intravitreal Administration in Participants With Diabetic Retinopathy

Обзор

This study will assess the safety, tolerability, and pharmacokinetics (PK) of intravitreal (IVT) injections of RO7663498 in participants with diabetic retinopathy (DR).

Вмешательства

Препарат RO7663498
Participants will receive RO7663498 as per the schedule defined in the protocol.

Первичные конечные точки

Percentage of Participants With Ocular Adverse Events (AEs) [Срок оценки: Up to Week 20]
Percentage of Participants With Systemic (non-ocular) AEs [Срок оценки: Up to Week 20]
Number of Abnormalities Recorded in Standard Ophthalmological Assessments [Срок оценки: Up to Week 20]

Вторичные конечные точки (2)

Aqueous Humor (AH) Concentrations of RO7663498 [Срок оценки: Up to Week 12]
Serum Concentrations of RO7663498 [Срок оценки: Up to Week 20]

Критерии участия

Критерии включения

General Inclusion Criteria

Diagnosis of Diabetes Mellitus (DM) (Type 1 or Type 2), as defined by the World Health Organization and/or American Diabetes Association

Ocular Inclusion Criteria for the Study Eye

BCVA score at screening of >= 19 letters in study eye using Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity testing charts
Non-proliferative diabetic retinopathy (NPDR) as assessed by the investigator and confirmed by the Central reading center (CRC)
Collection of >= 90 micro liter (μL) AH deemed feasible and safe by the investigator.

Критерии исключения

General Exclusion Criteria:

Any known hypersensitivity to any of the following compounds: fluorescein; any dilating, anesthetic, or povidone iodine eye drops; or any excipients contained in the treatments used in this study.
History of hypersensitivity to biologic agents, the investigational drug, or any of the excipients contained in the formulation administered IVT or systemically.

Ocular Exclusion Criteria for the Study Eye

Center-involved Diabetic Macular Edema (DME)
Any history or concurrent ocular conditions/procedures and/or visual system conditions of the below.
Vitreoretinal surgery/pars plana vitrectomy.
Any history of glaucoma surgery or planned glaucoma surgery during the study.
Uncontrolled glaucoma
Anterior segment neovascularization.
Vitreous or preretinal hemorrhage.
Any ocular disease other than DR and DME that may Confound assessment of the retina in the opinion of the investigator or Confound development of worsening DR, DME, or retinal nonperfusion.
Any presence of active intraocular inflammation on Day 1 (i.e., Standardization of Uveitis Nomenclature \[SUN\] criteria > 0 or National Eye Institute \[NEI\] vitreous haze grading > 0) or any history of IOI.
Aphakia or previous violation of the posterior capsule in the study eye

Ocular Exclusion Criteria for the Non-study Eye