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

March 18, 2019 updated by: Boehringer Ingelheim

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussel, Belgium, 1020
        • Brussels-UNIV Brugmann -Horta
      • Leuven, Belgium, 3000
        • Leuven - UNIV UZ Leuven (Sint-Rafaël)
  • France
      • Marseille, France, 13915
        • HOP Nord
      • Nantes, France, 44093
        • HOP Hôtel-Dieu
      • Paris, France, 75010
        • HOP Lariboisière
      • Paris, France, 75012
        • Hosp National 15-20, Ophtalmo, Paris
      • Toulouse, France, 31059
        • HOP Pierre Paul Riquet
  • Germany
      • Aachen, Germany, 52074
        • Universitätsklinikum Aachen, AöR
      • Ahaus, Germany, 48683
        • Augen Zentrum Nordwest, Ahaus
      • Bayreuth, Germany, 95444
        • Kamppeter Augenzentrum, Bayreuth
      • Göttingen, Germany, 37075
        • Universitätsmedizin Göttingen, Georg-August-Universität
      • Mainz, Germany, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
      • Troisdorf-Sieglar, Germany, 53844
        • Augenarzt Dr. Dunker und Kollegen, Troisdorf
      • Tübingen, Germany, 72076
        • Universitatsklinikum Tubingen
      • Ulm, Germany, 89075
        • Universitatsklinikum Ulm
  • Greece
      • Athens, Greece, 12462
        • Attikon, Panepistimiako Geniko Nosokomeio
      • Herakleion,Crete, Greece, 71110
        • University General Hospital of Heraklion
      • Patras, Greece, 26504
        • University of Patras Medical School
  • Hungary
      • Budapest, Hungary, 1145
        • Uzsoki Street Hospital, Budapest
      • Miskolc, Hungary, 3526
        • BAZ County Hospital, Ophtalmology Department, Miskolc
      • Szeged, Hungary, 6720
        • Univ.Szeged;Szent-Gyorgyi;Albert Heal.Cent.Ophtalmology Dep
  • Portugal
      • Braga, Portugal, 4710-243
        • Hospital de Braga-Escala Braga
      • Coimbra, Portugal, 3000-548
        • AIBILI - Association for Innovation and Biomedical Research on Light and Image
      • Porto, Portugal, 4200-319
        • Centro Hospitalar São João,EPE
      • Vila Franca de Xira, Portugal, 2600-009
        • Hospital de Vila Franca de Xira
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Barcelona, Spain, 08025
        • Hospital dos de maig
      • Madrid, Spain, 28046
        • Hospital La Paz
      • Santiago de Compostela, Spain, 15706
        • Instituto Oftalmológico Gómez-Ulla
      • Valladolid, Spain, 47005
        • Hospital Clinico Universitario de Valladolid
  • United Kingdom
      • Frimley, United Kingdom, GU16 7UJ
        • Frimley Park Hospital
      • Guildford, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital
      • London, United Kingdom, EC1V 2PD
        • Moorfields Eye Hospital
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Placebo
Drug: Placebo
Experimental: BI 1026706
Drug: BI 1026706

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Central Subfield Foveal Thickness (CSFT) at Week 12
Time Frame: 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.
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Serious Adverse Events (SAEs), Investigator Defined Drug-related Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)
Time Frame: 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.
From first drug administration until 4 days after last drug administration, up to 89 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2016

Primary Completion (Actual)

October 23, 2017

Study Completion (Actual)

October 24, 2017

Study Registration Dates

First Submitted

April 5, 2016

First Submitted That Met QC Criteria

April 5, 2016

First Posted (Estimate)

April 11, 2016

Study Record Updates

Last Update Posted (Actual)

March 20, 2019

Last Update Submitted That Met QC Criteria

March 18, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1320.22
  • 2015-003529-33 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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