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

Phase 2

Completed

• Conditions: Wet Macular Degeneration
• Interventions: Drug: BI 144807

• Registration Number: NCT02121522
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-22
• Study First Submitted QC: 2014-04-22
• Study First Posted: 2014-04-23
• Study Start: 2014-06
• Primary Completion: 2015-03
• Study Completion: 2015-04
• Results First Submitted: 2016-04-07
• Status Verified: 2016-06
• Results First Submitted QC: 2016-06-10
• Last Update Submitted: 2016-06-10
• Results First Posted: 2016-06-27
• Last Update Posted: 2016-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BI 144807	BI 144807	twice daily

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (10)

1313.20.49003 Boehringer Ingelheim Investigational Site; 🇩🇪 Tübingen, Germany

1313.20.49002 Boehringer Ingelheim Investigational Site; 🇩🇪 Leipzig, Germany

1313.20.49004 Boehringer Ingelheim Investigational Site; 🇩🇪 Bonn, Germany

1313.20.49001 Boehringer Ingelheim Investigational Site; 🇩🇪 Lübeck, Germany

1313.20.49005 Boehringer Ingelheim Investigational Site; 🇩🇪 Münster, Germany

1313.20.36003 Boehringer Ingelheim Investigational Site; 🇭🇺 Budapest, Hungary

1313.20.36001 Boehringer Ingelheim Investigational Site; 🇭🇺 Debrecen, Hungary

1313.20.36002 Boehringer Ingelheim Investigational Site; 🇭🇺 Budapest, Hungary

1313.20.43001 Boehringer Ingelheim Investigational Site; 🇦🇹 Wien, Austria

1313.20.49006 Boehringer Ingelheim Investigational Site; 🇩🇪 Ulm, Germany