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

NCT02732951 | Completed Phase 2 Results

• 2 other identifiers: 1320.222015-003529-33
• Study Type: interventional
• Target: 105
• Locations: 8 countries
• Sites: 35

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Central Subfield Foveal Thickness (CSFT) at 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 Outcomes (1)

• 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.

Study Arms (2)

BI 1026706

EXPERIMENTAL

Drug: BI 1026706

Placebo

ACTIVE COMPARATOR

Drug: Placebo

Interventions

BI 1026706 DRUG

BI 1026706

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (35)

Brussels-UNIV Brugmann -Horta

Brussels, 1020, Belgium

Location

Leuven - UNIV UZ Leuven (Sint-Rafaël)

Leuven, 3000, Belgium

Location

HOP Nord

Marseille, 13915, France

Location

HOP Hôtel-Dieu

Nantes, 44093, France

Location

HOP Lariboisière

Paris, 75010, France

Location

Hosp National 15-20, Ophtalmo, Paris

Paris, 75012, France

Location

HOP Pierre Paul Riquet

Toulouse, 31059, France

Location

Universitätsklinikum Aachen, AöR

Aachen, 52074, Germany

Location

Augen Zentrum Nordwest, Ahaus

Ahaus, 48683, Germany

Location

Kamppeter Augenzentrum, Bayreuth

Bayreuth, 95444, Germany

Location

Universitätsmedizin Göttingen, Georg-August-Universität

Göttingen, 37075, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

Augenarzt Dr. Dunker und Kollegen, Troisdorf

Troisdorf-Sieglar, 53844, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Universitätsklinikum Ulm

Ulm, 89075, Germany

Location

Attikon, Panepistimiako Geniko Nosokomeio

Athens, 12462, Greece

Location

University General Hospital of Heraklion

Herakleion,Crete, 71110, Greece

Location

University of Patras Medical School

Pátrai, 26504, Greece

Location

Uzsoki Street Hospital, Budapest

Budapest, 1145, Hungary

Location

BAZ County Hospital, Ophtalmology Department, Miskolc

Miskolc, 3526, Hungary

Location

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

Szeged, 6720, Hungary

Location

Hospital de Braga-Escala Braga

Braga, 4710-243, Portugal

Location

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

Coimbra, 3000-548, Portugal

Location

Centro Hospitalar São João,EPE

Porto, 4200-319, Portugal

Location

Hospital de Vila Franca de Xira

Vila Franca de Xira, 2600-009, Portugal

Location

Hospital Dos de Maig

Barcelona, 08025, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital La Paz

Madrid, 28046, Spain

Location

Instituto Oftalmológico Gómez-Ulla

Santiago de Compostela, 15706, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, 47005, Spain

Location

Frimley Park Hospital

Frimley, GU16 7UJ, United Kingdom

Location

Royal Surrey County Hospital

Guildford, GU2 7XX, United Kingdom

Location

Moorfields Eye Hospital

London, EC1V 2PD, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Macular Edema

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: Boehringer Ingelheim, Call Centre
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: April 11, 2016
• Study Start: April 14, 2016
• Primary Completion: October 23, 2017
• Study Completion: October 24, 2017
• Last Updated: March 20, 2019
• Results First Posted: March 20, 2019

Record last verified: 2019-03

Locations

HU (3); BE (2); PT (4); FR (5); GR (3); DE (8); ES (5); GB (5)