Wet Macular DegenerationPhase 2NCT02121522
A 4 Week Study With BI 144807 in Patients >= 50 Years With Wet Age Related Macular Degeneration
A Phase 2 study testing BI 144807 in people with Wet Macular Degeneration, run by Boehringer Ingelheim at 10 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Wet Macular Degeneration
- What is being tested?
- BI 144807
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Jun 2014to Apr 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed men and women with unilateral subfoveal choroideal neovascularization secondary to age-related macular degeneration
Who cannot join
- Additional eye disease that could compromizse best corrected visual acuity, such as uncontrolled glaucoma
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Germany6 sites
1313.20.49004 Boehringer Ingelheim Investigational Site
Bonn
1313.20.49002 Boehringer Ingelheim Investigational Site
Leipzig
1313.20.49001 Boehringer Ingelheim Investigational Site
Lübeck
1313.20.49005 Boehringer Ingelheim Investigational Site
Münster
1313.20.49003 Boehringer Ingelheim Investigational Site
Tübingen
1313.20.49006 Boehringer Ingelheim Investigational Site
Ulm
Hungary3 sites
1313.20.36002 Boehringer Ingelheim Investigational Site
Budapest
1313.20.36003 Boehringer Ingelheim Investigational Site
Budapest
1313.20.36001 Boehringer Ingelheim Investigational Site
Debrecen
About this study
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)
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.
- Conditions
- Wet Macular Degeneration
- Being tested
- BI 144807
- Medical subject headings
- Wet Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 144807Drug
twice daily
| Study group | Role | What they receive |
|---|---|---|
| BI 144807 | Experimental | twice daily Receives: Drug: BI 144807 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (day 1) and day 29
Secondary outcomes (1)
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.
Measured: Baseline and day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Wet Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121522
- Sponsor's protocol ID
- 1313.20
- Other IDs
- 2013-004567-30
- Status last verified
- Jun 2016
- First submitted
- 22 Apr 2014
- Last updated
- 27 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02121522
- Acronym / sponsor ID
- 1313.20
- Conditions
- Wet Macular Degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Posted 27 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BI 144807 | Experimental | Drug: BI 144807twice daily |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Newly diagnosed men and women with unilateral subfoveal choroideal neovascularization secondary to age-related macular degeneration
Key exclusion criteria (1 listed)
- Additional eye disease that could compromizse best corrected visual acuity, such as uncontrolled glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 144807twice daily | Drug | BI 144807 |
Primary outcome
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.
1 secondary outcome
Change From Baseline in Neovascular Leakage Area as Assessed by FA on Day 29
Time frame: Baseline and day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
Related trials for Wet Macular Degeneration
RecruitingPhase 1/2
Safety and Efficacy of Oral HX9428 Tablets in Subjects With Wet Age-related Macular Degeneration (wAMD)
Wet Age-related Macular Degeneration (AMD)
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 3
4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
Macular Neovascularization Secondary to Age-Related Macular Degeneration
RecruitingPhase 3
Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
Neovascular Age-Related Macular Degeneration (nAMD)
RecruitingPhase 1/2
Study in Human iPSCs-derived RPE Cells Transplantation for Advanced (Late-stage) AMD
AMD - Age-Related Macular Degeneration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 144807 in people with Wet Macular Degeneration, run by Boehringer Ingelheim at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Hungary, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in CRT as Measured by SD-OCT on Day 29 (time frame: Baseline (day 1) and day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2016.