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

Primary Purpose

Wet Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BI 144807
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wet Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 1313.20.43001 Boehringer Ingelheim Investigational Site
  • 1313.20.49004 Boehringer Ingelheim Investigational Site
  • 1313.20.49002 Boehringer Ingelheim Investigational Site
  • 1313.20.49001 Boehringer Ingelheim Investigational Site
  • 1313.20.49005 Boehringer Ingelheim Investigational Site
  • 1313.20.49003 Boehringer Ingelheim Investigational Site
  • 1313.20.49006 Boehringer Ingelheim Investigational Site
  • 1313.20.36002 Boehringer Ingelheim Investigational Site
  • 1313.20.36003 Boehringer Ingelheim Investigational Site
  • 1313.20.36001 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BI 144807

Arm Description

twice daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 22, 2014
Last Updated
June 10, 2016
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT02121522
Brief Title
A 4 Week Study With BI 144807 in Patients >= 50 Years With Wet Age Related Macular Degeneration
Official Title
A Single Arm Open Label Study to Evaluate the Pharmacodynamics and Safety of a 4 wk Treatment With BI 144807 in Patients With Newly Diagnosed Wet Age Related Macular Degeneration (wAMD)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wet Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BI 144807
Arm Type
Experimental
Arm Description
twice daily
Intervention Type
Drug
Intervention Name(s)
BI 144807
Intervention Description
twice daily
Primary Outcome Measure Information:
Title
Change From Baseline in CRT as Measured by SD-OCT on Day 29
Description
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
Secondary Outcome Measure Information:
Title
Change From Baseline in Neovascular Leakage Area as Assessed by FA on Day 29
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1313.20.43001 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
1313.20.49004 Boehringer Ingelheim Investigational Site
City
Bonn
Country
Germany
Facility Name
1313.20.49002 Boehringer Ingelheim Investigational Site
City
Leipzig
Country
Germany
Facility Name
1313.20.49001 Boehringer Ingelheim Investigational Site
City
Lübeck
Country
Germany
Facility Name
1313.20.49005 Boehringer Ingelheim Investigational Site
City
Münster
Country
Germany
Facility Name
1313.20.49003 Boehringer Ingelheim Investigational Site
City
Tübingen
Country
Germany
Facility Name
1313.20.49006 Boehringer Ingelheim Investigational Site
City
Ulm
Country
Germany
Facility Name
1313.20.36002 Boehringer Ingelheim Investigational Site
City
Budapest
Country
Hungary
Facility Name
1313.20.36003 Boehringer Ingelheim Investigational Site
City
Budapest
Country
Hungary
Facility Name
1313.20.36001 Boehringer Ingelheim Investigational Site
City
Debrecen
Country
Hungary

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info

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

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