Wet Macular DegenerationNCT01448538
Non-Persistence/Non-Adherence (NP/NA) in Wet Age-related Macular Degeneration (wAMD) Patients in Germany
An observational study of Wet Macular Degeneration, run by Bayer at 1 site in Germany.
Trial summary
In the research study an observation of patients with wet age-related macular degeneration (wet AMD) will be performed. The term observational study indicates that the current course of therapy and the associated circumstances will be recorded. In this study, no medical care is changed. Also, no new drugs are tested. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wet Macular Degeneration
- What is being tested?
- Anti-VEGF injections
- Type of treatment
- Injection or infusion
- How many people
- 480 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: German wAMD patients with Anti-VEGF therapy included by centers responsible for intravitreal injections
Who may be able to join
- Patient has wet age-related macular degeneration (wAMD)
- Patient has already received at least one Anti-VEGF injection
- From a clinical standpoint, if there is an ophthalmological need for treatment it is probable that the patient gets additional anti-VEGF injections in the next year.
- The patient is able and willing to take part in the study (answering a short questionnaire in the study centre, 4 independent phone interviews during study period).
Who cannot join
- At time of inclusion visit, the study centre is only exceptionally responsible for the treatment of the patient.
- The patient is taking part in another study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Persistence/Non-Adherence of German wAMD Patients Related to Their Anti-VEGF Injections: Extent, Explanations and Patients' Preferences
In the research study an observation of patients with wet age-related macular degeneration (wet AMD) will be performed.
The term observational study indicates that the current course of therapy and the associated circumstances will be recorded. In this study, no medical care is changed. Also, no new drugs are tested.
Read more
This study is being conducted in about 30 centers in Germany. A total of approximately 500 patients will be enrolled. The study is designed for a period of 12 months.
At the beginning and end of the study the physician will document the patient data. Therefore will be used information from the patient records and documented visits. If such information is not available in the study center, the otherwise attending ophthalmologist will be consulted about the vision acuity values and visits in the observation period.
Furthermore, patients are asked to participate in three telephone interviews and fill out during their visits to the study center a short questionnaire about their current vision and their well-being. In the telephone interviews will be discussed with the patient about his wet AMD disease and its treatment, its experience and its perspectives as well as any problems occur.
- Conditions
- Wet Macular Degeneration
- Being tested
- Anti-VEGF injections
- Keywords
- Medication Non-Adherence, Medication Persistence, wet macular degeneration
- Medical subject headings
- Wet Macular Degeneration, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-VEGF injectionsDrug
All Anti-VEGF injections approved for the German market, dosages as defined by doctors
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Anti-VEGF injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-Persistence (NP) in the wAMD therapy in alternative study-specific definitions: (1) no eye exam for a period of at least 3 months OR (2) no 2 subsequent Anti-VEGF injections despite a clear medical need for injections
Measured: 12 months after a patient was included into the study
Secondary outcomes (4)
Extent of Non-Adherence (NA) in the Anti-VEGF-therapy in a study-specific definition: (1) no eye exam every 4th week OR (2) no Anti-VEGF injection despite a medical need for an injection
Measured: 12 months after inclusion of patients
Identifying NA/NP causes (multivariate analysis based on patient interviews; main factors are sociodemographics and patient preferences)
Measured: Measurement during patient interviews about 4/8 months after inclusion
Identifying NA/NP outcomes (assessed by visual acuity)
Measured: Every eye doctors visit between inclusion of patients and their exclusion
Identifying patients' preferences (based on patients' questionnaires) towards treatment and treatment schemes
Measured: Measurement during patient interview after about 11 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet Macular DegenerationStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448538
- Sponsor's protocol ID
- 15785
- Other IDs
- HE-WAMD-01
- Status last verified
- Sep 2015
- First submitted
- 4 Oct 2011
- Last updated
- 14 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Persistence/Non-Adherence of German wAMD Patients Related to Their Anti-VEGF Injections: Extent, Explanations and Patients' Preferences
- ClinicalTrials.gov ID
- NCT01448538
- Acronym / sponsor ID
- 15785
- Conditions
- Wet Macular Degeneration
- Keywords
- Medication Non-Adherence, Medication Persistence, wet macular degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 7 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the research study an observation of patients with wet age-related macular degeneration (wet AMD) will be performed.
The term observational study indicates that the current course of therapy and the associated circumstances will be recorded. In this study, no medical care is changed. Also, no new drugs are tested.
This study is being conducted in about 30 centers in Germany. A total of approximately 500 patients will be enrolled. The study is designed for a period of 12 months.
At the beginning and end of the study the physician will document the patient data. Therefore will be used information from the patient records and documented visits. If such information is not available in the study center, the otherwise attending ophthalmologist will be consulted about the vision acuity values and visits in the observation period.
Furthermore, patients are asked to participate in three telephone interviews and fill out during their visits to the study center a short questionnaire about their current vision and their well-being. In the telephone interviews will be discussed with the patient about his wet AMD disease and its treatment, its experience and its perspectives as well as any problems occur.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Anti-VEGF injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- German wAMD patients with Anti-VEGF therapy included by centers responsible for intravitreal injections
Key inclusion criteria (4 listed)
- Patient has wet age-related macular degeneration (wAMD)
- Patient has already received at least one Anti-VEGF injection
- From a clinical standpoint, if there is an ophthalmological need for treatment it is probable that the patient gets additional anti-VEGF injections in the next year.
- The patient is able and willing to take part in the study (answering a short questionnaire in the study centre, 4 independent phone interviews during study period).
Key exclusion criteria (2 listed)
- At time of inclusion visit, the study centre is only exceptionally responsible for the treatment of the patient.
- The patient is taking part in another study.
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 |
|---|---|---|
| Anti-VEGF injectionsAll Anti-VEGF injections approved for the German market, dosages as defined by doctors | Drug | Group 1 |
Primary outcome
Non-Persistence (NP) in the wAMD therapy in alternative study-specific definitions: (1) no eye exam for a period of at least 3 months OR (2) no 2 subsequent Anti-VEGF injections despite a clear medical need for injections
Time frame: 12 months after a patient was included into the study
4 secondary outcomes
Extent of Non-Adherence (NA) in the Anti-VEGF-therapy in a study-specific definition: (1) no eye exam every 4th week OR (2) no Anti-VEGF injection despite a medical need for an injection
Time frame: 12 months after inclusion of patients
Identifying NA/NP causes (multivariate analysis based on patient interviews; main factors are sociodemographics and patient preferences)
Time frame: Measurement during patient interviews about 4/8 months after inclusion
Identifying NA/NP outcomes (assessed by visual acuity)
Time frame: Every eye doctors visit between inclusion of patients and their exclusion
Identifying patients' preferences (based on patients' questionnaires) towards treatment and treatment schemes
Time frame: Measurement during patient interview after about 11 months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2015.
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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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wet Macular Degeneration, run by Bayer at 1 site in Germany.
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 4 inclusion and 2 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 14 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Non-Persistence (NP) in the wAMD therapy in alternative study-specific definitions: (1) no eye exam for a period of at least 3 months OR (2) no 2 subsequent Anti-VEGF injections despite a clear medical need for injections (time frame: 12 months after a patient was included into the study). 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 14 Sep 2015.