Wet Macular Degeneration
Conditions
Brief summary
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.
Interventions
DRUGBI 144807
twice daily
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in CRT as Measured by SD-OCT on Day 29 | Baseline (day 1) and 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Neovascular Leakage Area as Assessed by FA on Day 29 | Baseline and 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. |
Countries
Austria, Germany, Hungary
Participant flow
Pre-assignment details
This is a open-label, single-arm, 4-week proof-of-concept study.
Participants by arm
| Arm | Count |
|---|---|
| BI 144807 Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily) | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | BI 144807 |
|---|---|
| Age, Continuous | 75.0 Years STANDARD_DEVIATION 7.8 |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 14 |
| serious Total, serious adverse events | 1 / 14 |
Outcome results
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.
Time frame: Baseline (day 1) and day 29
Population: Treated set (WOCF). Missing values are imputed by the worst observation carried forward (WOCF) measurement (including baseline).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BI 144807 | Change From Baseline in CRT as Measured by SD-OCT on Day 29 | 44.0 μm | Standard Deviation 151.5 |
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.
Time frame: Baseline and day 29
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BI 144807 | Change From Baseline in Neovascular Leakage Area as Assessed by FA on Day 29 | -0.7 mm² | Standard Deviation 1.4 |