CompletedNCT02732951Updated Mar 20, 2019Results posted

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

A Phase 2 interventional study of BI 1026706 and Placebo in Macular Edema, sponsored by Boehringer Ingelheim. Completed at 35 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-20.

Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 105
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 studied

Macular Edema

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Macular Edema 848

In context

Macular Edema

848 studies on the registry are indexed under Macular Edema; 57 are open to participants now.

This study's enrollment of 105 is above the median of 50 across 624 interventional studies indexed under Macular Edema.

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Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,297 studies on the registry; 56 are open to participants now.

Of its 166 completed or terminated interventional studies of FDA-regulated products, 121 (73%) have results posted.

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 105 participants (actual)

Study arms

Experimental
BI 1026706
Drug: BI 1026706
Active comparator
Placebo
Drug: Placebo

Interventions

DrugBI 1026706
DrugPlacebo

What researchers measure

Primary outcomes

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.
Time frame: Baseline and Week 12

Secondary outcomes

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

Results

Posted Mar 20, 2019

Participant flow

This was randomised, double-blind, placebo-controlled, parallel-group trial to evaluate pharmacodynamics, safety and tolerability of orally administered Boehringer Ingelheim (BI) 1026706 for 12 weeks in patients with Diabetic Macular Oedema (DME).

Participant flow — Overall Study
Milestone	Placebo Matching to BI 1026706	BI 1026706
Started	53	52
Completed	48	46
Not completed	5	6
Withdrew: Other than listed	1	0
Withdrew: Lost to follow-up	0	1
Withdrew: Adverse event	4	4
Withdrew: Protocol violation	0	1

Outcome measures

PrimaryChange 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.

Time frame:: Baseline and Week 12
Reported as:: Mean · Micrometre [μm]

Change From Baseline in Central Subfield Foveal Thickness (CSFT) at Week 12
Micrometre [μm]	Placebo Matching to BI 1026706	BI 1026706
Change From Baseline in Central Subfield Foveal Thickness (CSFT) at Week 12	-6.19 ± 11.61	10.26 ± 11.64

Statistical analysis

Placebo Matching to BI 1026706 vs BI 1026706 · Mixed model for repeated measurements · p = 0.3199 · Adjusted mean: 16.45 · 95% CI -16.23 to 49.13Fixed effects of treatment, prior anti-diabetic macular oedema treatment status, visit, treatment by visit interaction, baseline, baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within patient errors.

SecondaryNumber of Subjects With Serious Adverse Events (SAEs), Investigator Defined Drug-related Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)

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.

Time frame:: From first drug administration until 4 days after last drug administration, up to 89 days.
Reported as:: Number · Count of participants

Number of Subjects With Serious Adverse Events (SAEs), Investigator Defined Drug-related Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)
Count of participants	Placebo Matching to BI 1026706	BI 1026706
Total with SAEs	2	7
Investigator defined drug-related AE	7	7
AESIs	0	1

Adverse events

Collected over From first drug administration until 4 days after last drug administration, up to 89 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo Matching to BI 1026706	0/53 (0%)	2/53 (3.8%)	12/53 (22.6%)
BI 1026706	0/52 (0%)	7/52 (13.5%)	14/52 (26.9%)

Most frequent serious events

Showing 10 of 11

Most frequent serious events
Event	Placebo Matching to BI 1026706	BI 1026706
Myocardial infarctionCardiac disorders	0/53	1/52
Inguinal herniaGastrointestinal disorders	0/53	1/52
PneumoniaInfections and infestations	0/53	1/52
Alanine aminotransferase increasedInvestigations	0/53	1/52
Aspartate aminotransferase increasedInvestigations	0/53	1/52
Haemoglobin decreasedInvestigations	0/53	1/52
Red blood cell count decreasedInvestigations	0/53	1/52
GlycosuriaRenal and urinary disorders	0/53	1/52
Reactive perforating collagenosisSkin and subcutaneous tissue disorders	0/53	1/52
Localised infectionInfections and infestations	1/53	0/52

Most frequent other events

Most frequent other events
Event	Placebo Matching to BI 1026706	BI 1026706
NasopharyngitisInfections and infestations	4/53	6/52
HeadacheNervous system disorders	1/53	4/52
Visual acuity reducedEye disorders	2/53	3/52
Gamma-glutamyltransferase increasedInvestigations	3/53	0/52
SomnolenceNervous system disorders	3/53	1/52

Baseline characteristics

Treated set (TS): TS includes all patients who were treated with at least 1 dose of trial drug, either BI 1026706 or placebo.

Age, Continuous
Age, Continuous(Years)	Placebo Matching to BI 1026706	BI 1026706	Total
Mean	62.2 ± 9.7	63.9 ± 8.7	63.0 ± 9.2

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo Matching to BI 1026706	BI 1026706	Total
Female	14	14	28
Male	39	38	77

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Placebo Matching to BI 1026706	BI 1026706	Total
Hispanic or Latino	4	4	8
Not Hispanic or Latino	35	43	78
Unknown or Not Reported	14	5	19

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Placebo Matching to BI 1026706	BI 1026706	Total
American Indian or Alaska Native	0	0	0
Asian	1	0	1
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	38	47	85
More than one race	0	0	0
Unknown or Not Reported	14	5	19

Study locations

35 sites

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

References and documents

Study documents

Statistical analysis plan · Jul 26, 2017
Study protocol · Mar 7, 2016

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02732951
Lead sponsor: Boehringer Ingelheim
Responsible party: Sponsor
First posted: Apr 11, 2016
Start date: Apr 14, 2016
Primary completion: Oct 23, 2017
Completion: Oct 24, 2017
Results posted: Mar 20, 2019
Last update: Mar 20, 2019

Study contacts

Boehringer Ingelheim

study chair · Boehringer Ingelheim

View the source record on ClinicalTrials.gov ↗

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