NCT02121522

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2014

Shorter than P25 for phase_2

Geographic Reach
3 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 23, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 27, 2016

Completed
Last Updated

June 27, 2016

Status Verified

June 1, 2016

Enrollment Period

9 months

First QC Date

April 22, 2014

Results QC Date

April 7, 2016

Last Update Submit

June 10, 2016

Conditions

Wet Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline (day 1) and day 29

Secondary Outcomes (1)

  • Change From Baseline in Neovascular Leakage Area as Assessed by FA on Day 29

    Baseline and day 29

Study Arms (1)

BI 144807

EXPERIMENTAL

twice daily

Drug: BI 144807

Interventions

BI 144807DRUG

twice daily

BI 144807

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed men and women with unilateral subfoveal choroideal neovascularization secondary to age-related macular degeneration

You may not qualify if:

  • Additional eye disease that could compromizse best corrected visual acuity, such as uncontrolled glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

1313.20.43001 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1313.20.49004 Boehringer Ingelheim Investigational Site

Bonn, Germany

Location

1313.20.49002 Boehringer Ingelheim Investigational Site

Leipzig, Germany

Location

1313.20.49001 Boehringer Ingelheim Investigational Site

Lübeck, Germany

Location

1313.20.49005 Boehringer Ingelheim Investigational Site

Münster, Germany

Location

1313.20.49003 Boehringer Ingelheim Investigational Site

Tübingen, Germany

Location

1313.20.49006 Boehringer Ingelheim Investigational Site

Ulm, Germany

Location

1313.20.36002 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1313.20.36003 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1313.20.36001 Boehringer Ingelheim Investigational Site

Debrecen, Hungary

Location

MeSH Terms

Conditions

Wet Macular Degeneration

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Limitations and Caveats

The trial was ended earlier as per protocol as the preliminary data showed that the likelihood to meet the trial's primary efficacy endpoint would have been low even if the patient recruitment had been continued.

Results Point of Contact

Title
Boehringer Ingelheim, Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2014

First Posted

April 23, 2014

Study Start

June 1, 2014

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

June 27, 2016

Results First Posted

June 27, 2016

Record last verified: 2016-06

Locations

HU(3)AU(1)DE(6)