Safety and Effect on Central Retinal Thickness of BI 1026706 in Patients With Diabetic Macular Edema
- Conditions
- Macular Edema
- Interventions
- Drug: BI 1026706Drug: Placebo
- Registration Number
- NCT02732951
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This is a proof of mechanism trial to explore the effect of BI 1026706 on the central retinal thickness and to evaluate safety and tolerability of BI 1026706 administered orally for 12 weeks in patients with mild vision impairment due to center-involved DME
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 1026706 BI 1026706 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change From Baseline in Central Subfield Foveal Thickness (CSFT) at Week 12 Baseline and Week 12 The change from baseline in CSFT at Week 12 and the BI 1026706 effect was compared between the BI 1026706 treatment group and the placebo group as measured by Spectral-domain Optical Coherence Tomography (SD-OCT). Baseline was defined as the CSFT value measured at the visit when patients were randomised. Mean presented here is an adjusted mean.
- Secondary Outcome Measures
Name Time Method Number of Subjects With Serious Adverse Events (SAEs), Investigator Defined Drug-related Adverse Events (AEs) and Adverse Events of Special Interest (AESIs) From first drug administration until 4 days after last drug administration, up to 89 days. Number of subjects with serious adverse events (SAEs), Investigator defined drug-related Adverse events (AEs) and adverse events of special interest (AESIs) comparing the BI 1026706 treatment group with the placebo group is presented.
Trial Locations
- Locations (35)
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital de Vila Franca de Xira
🇵🇹Vila Franca de Xira, Portugal
HOP Lariboisière
🇫🇷Paris, France
Royal Victoria Infirmary
🇬🇧Newcastle upon Tyne, United Kingdom
HOP Nord
🇫🇷Marseille, France
Hospital Dos de Maig
🇪🇸Barcelona, Spain
Hospital Clínico Universitario de Valladolid
🇪🇸Valladolid, Spain
Moorfields Eye Hospital
🇬🇧London, United Kingdom
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
HOP Pierre Paul Riquet
🇫🇷Toulouse, France
University General Hospital of Heraklion
🇬🇷Herakleion,Crete, Greece
Universitätsklinikum Aachen, AöR
🇩🇪Aachen, Germany
Universitätsmedizin Göttingen, Georg-August-Universität
🇩🇪Göttingen, Germany
Hospital La Paz
🇪🇸Madrid, Spain
Instituto Oftalmológico Gómez-Ulla
🇪🇸Santiago de Compostela, Spain
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
Frimley Park Hospital
🇬🇧Frimley, United Kingdom
Royal Surrey County Hospital
🇬🇧Guildford, United Kingdom
Southampton General Hospital
🇬🇧Southampton, United Kingdom
Augenarzt Dr. Dunker und Kollegen, Troisdorf
🇩🇪Troisdorf-Sieglar, Germany
Brussels-UNIV Brugmann -Horta
🇧🇪Brussel, Belgium
Leuven - UNIV UZ Leuven (Sint-Rafaël)
🇧🇪Leuven, Belgium
HOP Hôtel-Dieu
🇫🇷Nantes, France
Hosp National 15-20, Ophtalmo, Paris
🇫🇷Paris, France
Augen Zentrum Nordwest, Ahaus
🇩🇪Ahaus, Germany
Kamppeter Augenzentrum, Bayreuth
🇩🇪Bayreuth, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Uzsoki Street Hospital, Budapest
🇭🇺Budapest, Hungary
Hospital de Braga-Escala Braga
🇵🇹Braga, Portugal
AIBILI - Association for Innovation and Biomedical Research on Light and Image
🇵🇹Coimbra, Portugal
University of Patras Medical School
🇬🇷Patras, Greece
Attikon, Panepistimiako Geniko Nosokomeio
🇬🇷Athens, Greece
BAZ County Hospital, Ophtalmology Department, Miskolc
🇭🇺Miskolc, Hungary
Univ.Szeged;Szent-Gyorgyi;Albert Heal.Cent.Ophtalmology Dep
🇭🇺Szeged, Hungary
Centro Hospitalar São João,EPE
🇵🇹Porto, Portugal