Trial Outcomes & Findings for A 4 Week Study With BI 144807 in Patients >= 50 Years With Wet Age Related Macular Degeneration (NCT NCT02121522)

Last Updated: 2016-06-27

Results Overview

Change from baseline in central 1-mm retinal thickness (CRT) as measured by spectral domain optical coherence tomography (SD-OCT) on day 29.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Baseline (day 1) and day 29

Results posted on

2016-06-27

Participant Flow

This is a open-label, single-arm, 4-week proof-of-concept study.

Participant milestones

Participant milestones
Measure	BI 144807 Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
Overall Study STARTED	14
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	BI 144807 Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
Overall Study Adverse Event	1

Baseline Characteristics

A 4 Week Study With BI 144807 in Patients >= 50 Years With Wet Age Related Macular Degeneration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BI 144807 n=14 Participants Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
Age, Continuous	75.0 Years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (day 1) and day 29

Population: Treated set (WOCF). Missing values are imputed by the worst observation carried forward (WOCF) measurement (including baseline).

Change from baseline in central 1-mm retinal thickness (CRT) as measured by spectral domain optical coherence tomography (SD-OCT) on day 29.

Outcome measures

Outcome measures
Measure	BI 144807 n=14 Participants Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
Change From Baseline in CRT as Measured by SD-OCT on Day 29	44.0 μm Standard Deviation 151.5

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	BI 144807 n=10 Participants Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
Change From Baseline in Neovascular Leakage Area as Assessed by FA on Day 29	-0.7 mm² Standard Deviation 1.4

Adverse Events

BI 144807

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BI 144807 n=14 participants at risk Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
Eye disorders Retinal haemorrhage	7.1% 1/14 • From first drug administration until 5 days after last drug administration, up to 5 weeks.

Other adverse events

Other adverse events
Measure	BI 144807 n=14 participants at risk Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
Eye disorders Retinal haemorrhage	7.1% 1/14 • From first drug administration until 5 days after last drug administration, up to 5 weeks.
Gastrointestinal disorders Constipation	7.1% 1/14 • From first drug administration until 5 days after last drug administration, up to 5 weeks.
Gastrointestinal disorders Diarrhoea	7.1% 1/14 • From first drug administration until 5 days after last drug administration, up to 5 weeks.
General disorders Fatigue	7.1% 1/14 • From first drug administration until 5 days after last drug administration, up to 5 weeks.
Infections and infestations Bronchitis	7.1% 1/14 • From first drug administration until 5 days after last drug administration, up to 5 weeks.
Infections and infestations Oral herpes	7.1% 1/14 • From first drug administration until 5 days after last drug administration, up to 5 weeks.
Investigations Body temperature increased	7.1% 1/14 • From first drug administration until 5 days after last drug administration, up to 5 weeks.
Nervous system disorders Headache	14.3% 2/14 • From first drug administration until 5 days after last drug administration, up to 5 weeks.
Skin and subcutaneous tissue disorders Pruritus	7.1% 1/14 • From first drug administration until 5 days after last drug administration, up to 5 weeks.
Vascular disorders Hypertension	7.1% 1/14 • From first drug administration until 5 days after last drug administration, up to 5 weeks.

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER