Ophthalmology, Macular DegenerationNCT04067583
A Follow-up Physician Survey to Evaluate Physician Knowledge of Safety and Safe Use Information for Aflibercept Administered by Intravitreal Injection in Europe
An observational study of Ophthalmology, Macular Degeneration, run by Bayer at 1 site in Germany.
Trial summary
With this follow up physician survey researcher want to collect the same data from all participants of the study using a highly structured questionnaire. The questionnaire will gather information related to physician characteristics and experience with Aflibercept, as well as assess physicians' knowledge and… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ophthalmology, Macular Degeneration
- What is being tested?
- Physician questionnaire
- How many people
- 454 participants
- Where
- 1 siteGermany
- Study dates
- 8 Oct 2019to 23 Apr 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The source of information for the study will be self-reported data collected from physicians using standard questionnaires with closed-ended response choices. Countries included are France, Germany, Italy, Spain, and the United Kingdom.
Who may be able to join
- Has signed informed consent
- Is a licensed and practicing ophthalmologist
- Has prescribed and/or administered aflibercept to at least one patient in the past 6 months
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Physician Knowledge of Safety and Safe Use Information for Aflibercept Administered by Intravitreal Injection in Europe: A Follow-up Physician Survey
With this follow up physician survey researcher want to collect the same data from all participants of the study using a highly structured questionnaire. The questionnaire will gather information related to physician characteristics and experience with Aflibercept, as well as assess physicians' knowledge and understanding of storage and preparation, proper injection technique, and the risks associated with Aflibercept injection into the eye (intravitreal injection). Analysis will be done using descriptive statistics.
- Conditions
- Ophthalmology, Macular Degeneration
- Being tested
- Physician questionnaire
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician questionnaireOther
This is a one-time cross-sectional survey of physicians, conducted electronically; there are no in person visits
| Study group | Role | What they receive |
|---|---|---|
| Physicians with recent aflibercept experience | Ophthalmologists who have prescribed and/or administered aflibercept in the past 6 months Receives: Other: Physician questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of physicians responding correctly to each individual knowledge question
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start8 Oct 2019
- Primary completion15 Apr 2020
- Study completion23 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ophthalmology, 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
- Other
- Time perspective
- Prospective
- Enrolment
- 454 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067583
- Sponsor's protocol ID
- 20285
- Status last verified
- Apr 2021
- First submitted
- 22 Aug 2019
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Physician Knowledge of Safety and Safe Use Information for Aflibercept Administered by Intravitreal Injection in Europe: A Follow-up Physician Survey
- ClinicalTrials.gov ID
- NCT04067583
- Acronym / sponsor ID
- 20285
- Conditions
- Ophthalmology, Macular Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 454 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 23 Apr 2020 (actual)
- First posted
- 26 Aug 2019 (actual)
- 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.
With this follow up physician survey researcher want to collect the same data from all participants of the study using a highly structured questionnaire. The questionnaire will gather information related to physician characteristics and experience with Aflibercept, as well as assess physicians' knowledge and understanding of storage and preparation, proper injection technique, and the risks associated with Aflibercept injection into the eye (intravitreal injection). Analysis will be done using descriptive statistics.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physicians with recent aflibercept experience | – | Other: Physician questionnaireOphthalmologists who have prescribed and/or administered aflibercept in the past 6 months |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The source of information for the study will be self-reported data collected from physicians using standard questionnaires with closed-ended response choices. Countries included are France, Germany, Italy, Spain, and the United Kingdom.
Key inclusion criteria (3 listed)
- Has signed informed consent
- Is a licensed and practicing ophthalmologist
- Has prescribed and/or administered aflibercept to at least one patient in the past 6 months
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Physician questionnaireThis is a one-time cross-sectional survey of physicians, conducted electronically; there are no in person visits | Other | Physicians with recent aflibercept experience |
Primary outcome
Percentage of physicians responding correctly to each individual knowledge question
Time frame: Up to 1 year
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 8 Apr 2021.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ophthalmology, 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 3 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 8 Apr 2021. 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?
Percentage of physicians responding correctly to each individual knowledge question (time frame: Up to 1 year). 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 8 Apr 2021; AzTrials last refreshed its copy on 6 Nov 2026.