Clinical trial NCT02732951: Safety and Effect on Central Retinal Thickness of BI 1026706 in Patients With Diabetic Macular Edema
Official title: A Randomized, Double-masked, Placebo-controlled Exploratory Study to Evaluate Pharmacodynamics, Safety and Tolerability of Orally Administered BI 1026706 for 12 Weeks in Patients With Mild Visual Impairment Due to Center-involved Diabetic Macular Edema (DME)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Macular Edema
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-04-11
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion criteria:

* Patients 18 years of age and older
* Male patients or female patients of non-childbearing potential
* Diagnosis of Diabetes mellitus type 1 or type 2
* Retinal thickening due to Diabetic macular edema (DME) involving the center of the macula in the study eye as confirmed by the Investigator on clinical exam
* Center-involved DME confirmed on Spectral-Domain Optical Coherence Tomography (SD-OCT) with central subfield thickness (CSFT) of at least 300 µm in the study eye at screening, confirmed by Central Reading Centre
* Best corrected visual acuity ETDRS (Early Treatment Diabetic Retinopathy Study) letter score in the study eye of 84 or below, but at least 70 at screening
* Further inclusion criteria apply

Exclusion criteria:

* Macular edema considered to be due to other causes than DME in the study eye
* Additional eye disease in the study eye that, in the opinion of the Investigator, might affect macular edema or could compromise or alter visual acuity during the course of the trial
* Anterior segment and vitreous abnormalities in the study eye that would compromise the adequate assessment of the best corrected visual acuity or an adequate examination of the posterior pole
* Intraocular surgery in the study eye within 4 months prior to randomization or planned intraocular surgery, including cataract, during the study period
* Proliferative diabetic retinopathy or iris neovascularisation in the study eye
* Aphakia in the study eye
* Any indication that requires immediate treatment or for which treatment is expected in the study eye with anti-Vascular Endothelial Growth Factor (VEGF) or with laser photocoagulation during the period, as per Investigator's judgment
* History of prior laser photocoagulation or other surgical, intravitreal or peribulbar treatment in the study eye within 4 months prior to randomization, either for DME or an ocular condition other than DME
* History of fluocinolone acetonide intravitreal implant in the study eye
* Application of intraocular corticosteroids in the study eye within 2 years prior to randomization in phakic eyes or 9 months in pseudophakic eyes
* History of topical steroid or nonsteroidal anti-inflammatory drugs (NSAID) treatment in the study eye within 30 days prior to randomization
* Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization
* Initiation of intensive insulin treatment (multiple daily injections or a pump) within 3 months prior to randomization or plans to do so in the next 4 months
* Change in oral antidiabetic medication within 3 months prior to randomization
* Patients with a clinically relevant abnormal screening haematology, blood chemistry, or urinalysis
* Renal impairment with estimated creatinine clearance \< 30 mL/min (as calculated by Cockcroft-Gault equation)
* Myocardial infarction or unstable angina pectoris within 3 months before randomization
* Uncontrolled arterial hypertension defined as a single measurement of systolic \>180 mmHg, two consecutive measurements of systolic \>160 mmHg, or diastolic \>100mmHg on optimal medical regimen
* Further exclusion criteria apply

Primary outcomes:
measure: Change From Baseline in Central Subfield Foveal Thickness (CSFT) at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Number of Subjects With Serious Adverse Events (SAEs), Investigator Defined Drug-related Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)
timeFrame: From first drug administration until 4 days after last drug administration, up to 89 days.
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Brussels-UNIV Brugmann -Horta
city: Leuven
country: Belgium
facility: Leuven - UNIV UZ Leuven (Sint-Rafaël)
city: Marseille
country: France
facility: HOP Nord
city: Nantes
country: France
facility: HOP Hôtel-Dieu
city: Paris
country: France
facility: HOP Lariboisière
city: Paris
country: France
facility: Hosp National 15-20, Ophtalmo, Paris
city: Toulouse
country: France
facility: HOP Pierre Paul Riquet
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen, AöR
city: Ahaus
country: Germany
facility: Augen Zentrum Nordwest, Ahaus
city: Bayreuth
country: Germany
facility: Kamppeter Augenzentrum, Bayreuth
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen, Georg-August-Universität
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Troisdorf-Sieglar
country: Germany
facility: Augenarzt Dr. Dunker und Kollegen, Troisdorf
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Athens
country: Greece
facility: Attikon, Panepistimiako Geniko Nosokomeio
city: Herakleion,Crete
country: Greece
facility: University General Hospital of Heraklion
city: Patras
country: Greece
facility: University of Patras Medical School
city: Budapest
country: Hungary
facility: Uzsoki Street Hospital, Budapest
city: Miskolc
country: Hungary
facility: BAZ County Hospital, Ophtalmology Department, Miskolc
city: Szeged
country: Hungary
facility: Univ.Szeged;Szent-Gyorgyi;Albert Heal.Cent.Ophtalmology Dep
city: Braga
country: Portugal
facility: Hospital de Braga-Escala Braga
city: Coimbra
country: Portugal
facility: AIBILI - Association for Innovation and Biomedical Research on Light and Image
city: Porto
country: Portugal
facility: Centro Hospitalar São João,EPE
city: Vila Franca de Xira
country: Portugal
facility: Hospital de Vila Franca de Xira
city: Barcelona
country: Spain
facility: Hospital Dos de Maig
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital La Paz
city: Santiago de Compostela
country: Spain
facility: Instituto Oftalmológico Gómez-Ulla
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: