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

Official title

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)

Overview

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.

Interventions

• Drug BI 1815368
  BI 1815368
• Drug Placebo
  Placebo matching BI 1815368

Primary outcome measures

• 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 [Time frame: at baseline, at week 48]

Secondary outcome measures (3)

• Occurrence (yes/no) of gain of ≥15 ETDRS letters compared with baseline in the study eye at Week 48 [Time frame: at baseline, at week 48]
• Occurrence (yes/no) of drug-related adverse events (AEs) over the treatment period through end of study (EoS) [Time frame: 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 [Time frame: at baseline, at week 48]

Eligibility criteria

Inclusion criteria

• ≥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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 32 centers

• 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
• … and 24 more centers

Poland · 10 centers

• 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
• … and 2 more centers

Japan · 9 centers

• 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
• … and 1 more center

United Kingdom · 9 centers

Center list to be confirmed — check the primary protocol.

Hungary · 8 centers

• 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

Czechia · 7 centers

• 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

China · 5 centers

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

Germany · 5 centers

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

Slovakia · 4 centers

• 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

Identifiers

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

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗