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

NCT ID: NCT02121522

Last Updated: 2016-06-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-04-30

Brief Summary

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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

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Conditions

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Wet Macular Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BI 144807

twice daily

Group Type EXPERIMENTAL

BI 144807

Intervention Type DRUG

twice daily

Interventions

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BI 144807

twice daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1313.20.43001 Boehringer Ingelheim Investigational Site

Vienna, , Austria

Site Status

1313.20.49004 Boehringer Ingelheim Investigational Site

Bonn, , Germany

Site Status

1313.20.49002 Boehringer Ingelheim Investigational Site

Leipzig, , Germany

Site Status

1313.20.49001 Boehringer Ingelheim Investigational Site

Lübeck, , Germany

Site Status

1313.20.49005 Boehringer Ingelheim Investigational Site

Münster, , Germany

Site Status

1313.20.49003 Boehringer Ingelheim Investigational Site

Tübingen, , Germany

Site Status

1313.20.49006 Boehringer Ingelheim Investigational Site

Ulm, , Germany

Site Status

1313.20.36002 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Site Status

1313.20.36003 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Site Status

1313.20.36001 Boehringer Ingelheim Investigational Site

Debrecen, , Hungary

Site Status

Countries

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Austria Germany Hungary

Other Identifiers

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2013-004567-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1313.20

Identifier Type: -

Identifier Source: org_study_id

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