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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004567-30 | EudraCT Number | EudraCT |
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The present trial will use an open label design to investigate the effect of BI 144807 on central 1-mm retinal thickness and presence of neovascular leakage in newly diagnosed wAMD patients. A further objective is to collect data on adverse events, vital signs, ECG and clinical laboratory parameters of BI 144807 in the same patient group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 144807 | Experimental | twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 144807 | Drug | twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in CRT as Measured by SD-OCT on Day 29 | Change from baseline in central 1-mm retinal thickness (CRT) as measured by spectral domain optical coherence tomography (SD-OCT) on day 29. | Baseline (day 1) and day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Neovascular Leakage Area as Assessed by FA on Day 29 | Change from baseline in neovascular leakage area as assessed by Fluorescein angiography (FA) on day 29. Baseline is defined as the last value collected before the first trial drug intake. Data collected after start of wet age-related macular degeneration (wAMD) therapy are set to missing. | Baseline and day 29 |
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Inclusion criteria:
Newly diagnosed men and women with unilateral subfoveal choroideal neovascularization secondary to age-related macular degeneration
Exclusion criteria:
Additional eye disease that could compromizse best corrected visual acuity, such as uncontrolled glaucoma
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1313.20.43001 Boehringer Ingelheim Investigational Site | Vienna | Austria | ||||
| 1313.20.49004 Boehringer Ingelheim Investigational Site |
This is a open-label, single-arm, 4-week proof-of-concept study.
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| ID | Title | Description |
|---|---|---|
| FG000 | BI 144807 | Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated set (TS): All patients who were dispensed study medication and were documented to have taken at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | BI 144807 | Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in CRT as Measured by SD-OCT on Day 29 | Change from baseline in central 1-mm retinal thickness (CRT) as measured by spectral domain optical coherence tomography (SD-OCT) on day 29. | Treated set (WOCF). Missing values are imputed by the worst observation carried forward (WOCF) measurement (including baseline). | Posted | Mean | Standard Deviation | μm | Baseline (day 1) and day 29 |
|
|
From first drug administration until 5 days after last drug administration, up to 5 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BI 144807 | Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal haemorrhage | Eye disorders | 18.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal haemorrhage | Eye disorders | 18.0 | Systematic Assessment |
The trial was ended earlier as per protocol as the preliminary data showed that the likelihood to meet the trial's primary efficacy endpoint would have been low even if the patient recruitment had been continued.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D057135 | Wet Macular Degeneration |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| Bonn |
| Germany |
| 1313.20.49002 Boehringer Ingelheim Investigational Site | Leipzig | Germany |
| 1313.20.49001 Boehringer Ingelheim Investigational Site | Lübeck | Germany |
| 1313.20.49005 Boehringer Ingelheim Investigational Site | Münster | Germany |
| 1313.20.49003 Boehringer Ingelheim Investigational Site | Tübingen | Germany |
| 1313.20.49006 Boehringer Ingelheim Investigational Site | Ulm | Germany |
| 1313.20.36002 Boehringer Ingelheim Investigational Site | Budapest | Hungary |
| 1313.20.36003 Boehringer Ingelheim Investigational Site | Budapest | Hungary |
| 1313.20.36001 Boehringer Ingelheim Investigational Site | Debrecen | Hungary |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Change From Baseline in Neovascular Leakage Area as Assessed by FA on Day 29 | Change from baseline in neovascular leakage area as assessed by Fluorescein angiography (FA) on day 29. Baseline is defined as the last value collected before the first trial drug intake. Data collected after start of wet age-related macular degeneration (wAMD) therapy are set to missing. | Treated set (OC). Observed Case (OC): This method analysed only available data that were observed while patients were on treatment, ie., missing data were not imputed. | Posted | Mean | Standard Deviation | mm² | Baseline and day 29 |
|
|
|
| 1 |
| 14 |
| 6 |
| 14 |
| Constipation | Gastrointestinal disorders | 18.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | 18.0 | Systematic Assessment |
|
| Fatigue | General disorders | 18.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | 18.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | 18.0 | Systematic Assessment |
|
| Body temperature increased | Investigations | 18.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | 18.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | 18.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | 18.0 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.