Safety and Effect on Central Retinal Thickness of BI 1026706 in Patients With Diabetic Macular Edema

NCT ID: NCT02732951

Last Updated: 2019-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-14
• Study Completion Date: 2017-10-24

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

Conditions

Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BI 1026706

Group Type: EXPERIMENTAL

BI 1026706

Intervention Type: DRUG

Placebo

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

BI 1026706

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Brussels-UNIV Brugmann -Horta

Brussels, , Belgium

Leuven - UNIV UZ Leuven (Sint-Rafaël)

Leuven, , Belgium

HOP Nord

Marseille, , France

HOP Hôtel-Dieu

Nantes, , France

HOP Lariboisière

Paris, , France

Hosp National 15-20, Ophtalmo, Paris

Paris, , France

HOP Pierre Paul Riquet

Toulouse, , France

Universitätsklinikum Aachen, AöR

Aachen, , Germany

Augen Zentrum Nordwest, Ahaus

Ahaus, , Germany

Kamppeter Augenzentrum, Bayreuth

Bayreuth, , Germany

Universitätsmedizin Göttingen, Georg-August-Universität

Göttingen, , Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, , Germany

Augenarzt Dr. Dunker und Kollegen, Troisdorf

Troisdorf-Sieglar, , Germany

Universitätsklinikum Tübingen

Tübingen, , Germany

Universitätsklinikum Ulm

Ulm, , Germany

Attikon, Panepistimiako Geniko Nosokomeio

Athens, , Greece

University General Hospital of Heraklion

Herakleion,Crete, , Greece

University of Patras Medical School

Pátrai, , Greece

Uzsoki Street Hospital, Budapest

Budapest, , Hungary

BAZ County Hospital, Ophtalmology Department, Miskolc

Miskolc, , Hungary

Univ.Szeged;Szent-Gyorgyi;Albert Heal.Cent.Ophtalmology Dep

Szeged, , Hungary

Hospital de Braga-Escala Braga

Braga, , Portugal

AIBILI - Association for Innovation and Biomedical Research on Light and Image

Coimbra, , Portugal

Centro Hospitalar São João,EPE

Porto, , Portugal

Hospital de Vila Franca de Xira

Vila Franca de Xira, , Portugal

Hospital Dos de Maig

Barcelona, , Spain

Hospital Vall d'Hebron

Barcelona, , Spain

Hospital La Paz

Madrid, , Spain

Instituto Oftalmológico Gómez-Ulla

Santiago de Compostela, , Spain

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Frimley Park Hospital

Frimley, , United Kingdom

Royal Surrey County Hospital

Guildford, , United Kingdom

Moorfields Eye Hospital

London, , United Kingdom

Royal Victoria Infirmary

Newcastle upon Tyne, , United Kingdom

Southampton General Hospital

Southampton, , United Kingdom

Countries

Belgium; France; Germany; Greece; Hungary; Portugal; Spain; United Kingdom

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

2015-003529-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1320.22

Identifier Type: -

Identifier Source: org_study_id