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

June 10, 2016 updated by: Boehringer Ingelheim

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria
        • 1313.20.43001 Boehringer Ingelheim Investigational Site
  • Germany
      • Bonn, Germany
        • 1313.20.49004 Boehringer Ingelheim Investigational Site
      • Leipzig, Germany
        • 1313.20.49002 Boehringer Ingelheim Investigational Site
      • Lübeck, Germany
        • 1313.20.49001 Boehringer Ingelheim Investigational Site
      • Münster, Germany
        • 1313.20.49005 Boehringer Ingelheim Investigational Site
      • Tübingen, Germany
        • 1313.20.49003 Boehringer Ingelheim Investigational Site
      • Ulm, Germany
        • 1313.20.49006 Boehringer Ingelheim Investigational Site
  • Hungary
      • Budapest, Hungary
        • 1313.20.36002 Boehringer Ingelheim Investigational Site
      • Budapest, Hungary
        • 1313.20.36003 Boehringer Ingelheim Investigational Site
      • Debrecen, Hungary
        • 1313.20.36001 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BI 144807
twice daily
Drug: BI 144807
twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in CRT as Measured by SD-OCT on Day 29
Time Frame: 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.
Baseline (day 1) and day 29

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Neovascular Leakage Area as Assessed by FA on Day 29
Time Frame: 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.
Baseline and day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

April 22, 2014

First Submitted That Met QC Criteria

April 22, 2014

First Posted (Estimate)

April 23, 2014

Study Record Updates

Last Update Posted (Estimate)

June 27, 2016

Last Update Submitted That Met QC Criteria

June 10, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1313.20
  • 2013-004567-30 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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