Macular EdemaPhase 2NCT02732951
Safety and Effect on Central Retinal Thickness of BI 1026706 in Patients With Diabetic Macular Edema
A Phase 2 study testing BI 1026706 in people with Macular Edema, run by Boehringer Ingelheim at 35 sites in 8 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema
- What is being tested?
- BI 1026706
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 35 sitesin 8 countries
- Study dates
- 14 Apr 2016to 24 Oct 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
35 sites in 8 countries.
35 sites in 8 countries
Germany8 sites
Universitätsklinikum Aachen, AöR
Aachen, 52074
Augen Zentrum Nordwest, Ahaus
Ahaus, 48683
Kamppeter Augenzentrum, Bayreuth
Bayreuth, 95444
Universitätsmedizin Göttingen, Georg-August-Universität
Göttingen, 37075
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
Augenarzt Dr. Dunker und Kollegen, Troisdorf
Troisdorf-Sieglar, 53844
Universitätsklinikum Tübingen
Tübingen, 72076
Universitätsklinikum Ulm
Ulm, 89075
France5 sites
HOP Nord
Marseille, 13915
HOP Hôtel-Dieu
Nantes, 44093
HOP Lariboisière
Paris, 75010
Hosp National 15-20, Ophtalmo, Paris
Paris, 75012
HOP Pierre Paul Riquet
Toulouse, 31059
Spain5 sites
Hospital Dos de Maig
Barcelona, 08025
Hospital Vall d'Hebron
Barcelona, 08035
Hospital La Paz
Madrid, 28046
Instituto Oftalmológico Gómez-Ulla
Santiago de Compostela, 15706
Hospital Clínico Universitario de Valladolid
Valladolid, 47005
United Kingdom5 sites
Frimley Park Hospital
Frimley, GU16 7UJ
Royal Surrey County Hospital
Guildford, GU2 7XX
Moorfields Eye Hospital
London, EC1V 2PD
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
Southampton General Hospital
Southampton, SO16 6YD
Portugal4 sites
Hospital de Braga-Escala Braga
Braga, 4710-243
AIBILI - Association for Innovation and Biomedical Research on Light and Image
Coimbra, 3000-548
Centro Hospitalar São João,EPE
Porto, 4200-319
Hospital de Vila Franca de Xira
Vila Franca de Xira, 2600-009
Greece3 sites
Attikon, Panepistimiako Geniko Nosokomeio
Athens, 12462
University General Hospital of Heraklion
Herakleion,Crete, 71110
University of Patras Medical School
Pátrai, 26504
Hungary3 sites
Uzsoki Street Hospital, Budapest
Budapest, 1145
BAZ County Hospital, Ophtalmology Department, Miskolc
Miskolc, 3526
Univ.Szeged;Szent-Gyorgyi;Albert Heal.Cent.Ophtalmology Dep
Szeged, 6720
Belgium2 sites
Brussels-UNIV Brugmann -Horta
Brussels, 1020
Leuven - UNIV UZ Leuven (Sint-Rafaël)
Leuven, 3000
About this study
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)
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
- Being tested
- BI 1026706, Placebo
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1026706Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BI 1026706 | Experimental | Not described Receives: Drug: BI 1026706 |
| Placebo | Active comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: From first drug administration until 4 days after last drug administration, up to 89 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study start14 Apr 2016
- Primary completion23 Oct 2017
- Study completion24 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732951
- Sponsor's protocol ID
- 1320.22
- Other IDs
- 2015-003529-33, 2015
- Status last verified
- Mar 2019
- First submitted
- 5 Apr 2016
- Last updated
- 20 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02732951
- Acronym / sponsor ID
- 1320.22
- Conditions
- Macular Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2016 (actual)
- Primary completion
- 23 Oct 2017 (actual)
- Study completion
- 24 Oct 2017 (actual)
- First posted
- 11 Apr 2016 (estimated)
- Results
- Posted 20 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 1026706 | Experimental | Drug: BI 1026706 |
| Placebo | Active comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 1026706 | Drug | BI 1026706 |
| Placebo | Drug | Placebo |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
35 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 1026706 in people with Macular Edema, run by Boehringer Ingelheim at 35 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Germany, France, Spain, United Kingdom, Portugal and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Central Subfield Foveal Thickness (CSFT) at Week 12 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.