A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema

Официальное название

A Randomised, Double-masked, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Oral BI 1815368 in Participants With Centre-involved Diabetic Macular Edema for 48 Weeks of Treatment (THULITE)

Обзор

This study is open to adults 18 and older with an eye condition called diabetic macular edema. People are required to have a specific type of diabetic macular edema called centre-involved diabetic macular edema (CI-DME) to take part. The purpose of this study is to find out whether a medicine called BI 1815368 improves sight in people with CI-DME and to find the most suitable dose. This study has 2 parts. In the first part, participants are put into 2 groups of equal size randomly, which means by chance. One group takes BI 1815368 tablets and the other group takes placebo tablets. Placebo tablets look like BI 1815368 tablets but do not contain any medicine. In the second part, participants are put into 4 groups of equal size randomly. 3 groups take different daily doses of the study medicine, BI 1815368, while 1 group takes placebo. All participants take tablets twice a day for about 11 months. Participants are in the study for about 1 year. During this time, they visit the study site 16 times. At visits, doctors check the participant's vision and collect information on any health problems. They take detailed pictures of the eye. The changes over time are compared between the groups to see if the treatment works.

Вмешательства

• Препарат BI 1815368
  BI 1815368
• Препарат Placebo
  Placebo matching BI 1815368

Первичные конечные точки

• Occurrence (yes/no) of a gain of ≥10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters compared with baseline in the study eye at Week 48 [Срок оценки: at baseline, at week 48]

Вторичные конечные точки (3)

• Occurrence (yes/no) of gain of ≥15 ETDRS letters compared with baseline in the study eye at Week 48 [Срок оценки: at baseline, at week 48]
• Occurrence (yes/no) of drug-related adverse events (AEs) over the treatment period through end of study (EoS) [Срок оценки: up to 52 weeks]
• Absolute change from baseline of central subfield foveal thickness (CST) as measured by spectral domain optical coherence tomography (SD-OCT) in the study eye at Week 48 [Срок оценки: at baseline, at week 48]

Критерии участия

Критерии включения

• ≥18 years of age
• Diagnosis of diabetes mellitus (DM) (type 1 or type 2), Haemoglobin A1C (HbA1c) <12% treated with stable medication for at least 30 days prior to Day 1; no already-set plans for major changes in DM medication (e.g. start of new medication) at the time of screening and baseline
• Centre-involved diabetic macular edema (CI-DME) confirmed on spectral domain optical coherence tomography (SD-OCT) with central subfield foveal thickness (CST) ≥320 µm in the study eye at screening
• Best corrected visual acuity (BCVA) visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye between 24 and 78 (Snellen equivalent range 20/320 to 20/32) at screening Further inclusion criteria apply.

Критерии исключения

• Macular edema considered to be due to other causes than CI-DME in the study eye
• Proliferative diabetic retinopathy or iris neovascularisation (including the anterior chamber angle) in the study eye
• Any intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) treatment within 4 months before Day 1 (other than faricimab or aflibercept 8mg), and within 6 months before Day 1 for faricimab or aflibercept 8 mg, and/or more than 4 prior IVT injections with anti-VEGF treatment in total in the study eye
• Any history of panretinal photocoagulation, macular laser photocoagulation, vitreoretinal surgery, IVT or periocular corticosteroid treatment (within 12 months before Day 1), history of fluocinolone ophthalmic implant or dexamethasone IVT implant before Day 1, or topical steroid or NSAID treatment (within 30 days before Day 1)
• Active ocular inflammation of any history of intraocular inflammation within 1 year
• Aphakia or total absence of the posterior capsule; Yttrium aluminium garnet (YAG) laser capsulotomy in the study eye is permitted if more than 2 months prior to Day 1 Further exclusion criteria apply.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 32 центра

• Arizona Retina & Vitreous Research, Central Phoenix — Phoenix
• Win Retina — Arcadia
• Retina Associates of Southern California — Huntington Beach
• Retinal Consultants Medical Group, Inc — Modesto
• Eye Research Foundation — Newport Beach
• Doheny Eye Center UCLA Arcadia — Pasadena
• Retina Consultants of San Diego — Poway
• West Coast Retina Medical Group, Inc. — San Francisco
• … и ещё 24 центра

Польша · 10 центров

• Szpital Swietego Lukasza S. A. — Bielsko-Biala
• Oculomedica Sp. z o.o. — Bydgoszcz
• Clinical Medical Research Sp. z o.o. — Katowice
• Szpital Sw. Rozy Sp. z o.o. — Krakow
• Centrum Medyczne Dietla 19 Sp. z o.o. — Krakow
• Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o. — Olsztyn
• Poznanskie Centrum Wzroku sp z o o — Poznan
• Caminomed Sp. z o.o. — Tarnowskie Góry
• … и ещё 2 центра

Япония · 9 центров

• Asahikawa Medical University Hospital — Asahikawa-shi
• Tokyo Medical University Hachioji Medical Center — Hachioji-shi
• Kagawa University Hospital — Kita-gun
• Kurume University Hospital — Kurume-shi
• Shinshu University Hospital — Matsumoto-shi
• National Hospital Organization Tokyo Medical Center — Meguro-ku
• Nagoya City University Hospital — Nagayoga
• Tokyo Women's Medical University Hospital — Tokyo
• … и ещё 1 центр

Великобритания · 9 центров

Список центров уточняется — проверьте первичный протокол.

Венгрия · 8 центров

• Central Hospital of Northern Pest - Military Hospital — Budapest
• Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet — Budapest
• Budapest Retina Associations Kft. — Budapest
• Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet — Budapest
• University of Debrecen — Debrecen
• Nozologen Kft. — Pécs
• University of Pecs — Pécs
• University of Szeged — Szeged

Чехия · 7 центров

• University Hospital Hradec Kralove (FNHK) — Hradec Králové
• University Hospital Ostrava — Ostrava-Poruba
• Oftex s.r.o. — Pardubice
• Fakultni nemocnice Kralovske Vinohrady — Prague
• Vseobecna fakultni nemocnice v Praze — Prague
• Fakultni Thomayerova nemocnice — Prague
• Axon Clinical s.r.o. — Prague

Китай · 5 центров

• West China Hospital, Sichuan University — Чэнду
• Shanghai General Hospital — Шанхай
• The Fourth People's Hospital of Shenyang — Шэньян
• Shijiazhuang People's Hospital — Shijiazhuang
• Shanxi Eye Hospital — Taiyuan

Германия · 5 центров

• Universitaetsklinikum Carl Gustav Carus TU Dresden — Dresden
• Universitätsklinikum Düsseldorf — Düsseldorf
• Universitätsklinikum Leipzig — Leipzig
• Universitätsklinikum Mannheim GmbH — Mannheim
• Augenzentrum am St. Franziskus-Hospital Münster — Münster

Словакия · 4 центра

• F D Roosevelt University General Hospital Of Banska Bystrica — Banská Bystrica
• Nemocnica s poliklinikou Trebisov a.s. — Trebišov
• Fakultna nemocnica Trencin — Trenčín
• Fakultna nemocnica s poliklinikou Zilina — Žilina

Идентификаторы

NCT: NCT06962839 · 1485-0018 · U1111-1317-2206 · 2024-520384-14-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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