Neovascular Age-related Macular Degeneration (nAMD), Diabetic Macular Edema (DME), Retinal Vein Occlusion (RVO)NCT07308639
DATA-INSIGHT is a Project That Looks at Health Data in Germany to Find Out How Many Patients Suffer From Eye Disease. The Project Also Explores New Ways to Collect and Use Publicly Available Healthcare Information.
An observational study of Neovascular Age-related Macular Degeneration (nAMD), Diabetic Macular Edema (DME), Retinal Vein Occlusion (RVO), run by Bayer at 1 site in Germany.
Trial summary
The main goal of this study is to find out how common certain eye diseases are in Germany and how they have changed over time. The diseases being studied are: nAMD (neovascular age-related macular degeneration): a condition that affects the central part of the retina and can cause vision loss in older adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration (nAMD), Diabetic Macular Edema (DME), Retinal Vein Occlusion (RVO)
- What is being tested?
- anti-VEGF medication
- How many people
- 50,000 participants
- Where
- 1 siteGermany
- Study dates
- 3 Mar 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: all participants with the diagnosis of nAMD, DME and RVO from the FDZ and FDGP databases between 1 Jan 2009 and 31 Dec 2024
Who may be able to join
- At least one diagnosis of nAMD, DME and RVO in the timeframe 01 JAN 2009 until 31 DEC 2024
- nAMD patients aged ≥ 50 years
- DME patients aged ≥18 years
- RVO patients aged ≥18 years
- Participants living in Germany covered by statutory health insurance or private health insurance
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: DATA-INSIGHT: Data Analysis for Treatment Assessment and Evaluation of New Sources for Evidence Generation in German Healthcare System
The main goal of this study is to find out how common certain eye diseases are in Germany and how they have changed over time. The diseases being studied are:
nAMD (neovascular age-related macular degeneration): a condition that affects the central part of the retina and can cause vision loss in older adults.
Read more
DME (diabetic macular edema): a swelling in the central part of the retina caused by diabetes, which can also lead to vision problems.
RVO (retinal vein occlusion): a blockage of the veins in the retina, which can cause sudden vision loss.
Researchers will look at data collected from 2009 to 2024 to see how often these diseases occur (incidence) and how many people have them at a given time (prevalence). They will use two large sets of health data from Germany, called FDZ and FDGP.
The main question is: How do the numbers of new and existing cases of nAMD, DME, and RVO compare between the two data sources (FDZ and FDGP) in Germany from 2009 to 2024? The study also wants to find out if factors like age, other health problems, and medications affect how common these eye diseases are.
Another goal is to see how many people with these eye diseases are treated with a type of medicine called anti-VEGF, which is used to slow down or stop vision loss.
In summary, this study will help us understand how these eye diseases affect people in Germany, how they are treated, and whether different groups of people are more likely to get them.
- Being tested
- anti-VEGF medication
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-VEGF medicationDrug
according to local label and treating physician
| Study group | Role | What they receive |
|---|---|---|
| nAMD cohort | participants diagnosed with nAMD Receives: Drug: anti-VEGF medication | |
| DME cohort | participants diagnosed with DME Receives: Drug: anti-VEGF medication | |
| RVO cohort | participants diagnosed with RVO Receives: Drug: anti-VEGF medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of nAMD, DME and RVO of FDZ and FDPG in Germany
one-year incidence rate is defined as all new patients fulfilling the inclusion and exclusion criteria in each data repository in the respective year for the first time compared to all patients in the repository in the given year.
Measured: 1 Jan 2009 - 31 Dec 2024
prevalence of nAMD, DME and RVO in Germany
one-year prevalence rate is defined as the proportion of patients fulfilling inclusion and exclusion criteria in each data repository in the respective year PLUS patients identified in any previous year in relation to all patients in the repository in the given year.
Measured: 1 Jan 2009 - 31 Dec 2024
Secondary outcomes (4)
incidence of nAMD, DME and RVO of FDZ and FDPG in Germany influenced by demographics, comorbidities, medications and data sources
one-year incidence rate is defined as all new patients fulfilling the inclusion and exclusion criteria in each data repository in the respective year for the first time compared to all patients in the repository in the given year.
Measured: 1 Jan 2009 - 31 Dec 2024
prevalence of nAMD, DME and RVO of FDZ and FDPG in Germany influenced by demographics, comorbidities, medications and data sources
one-year prevalence rate is defined as the proportion of patients fulfilling inclusion and exclusion criteria in each data repository in the respective year PLUS patients identified in any previous year in relation to all patients in the repository in the given year.
Measured: 1 Jan 2009 - 31 Dec 2024
Number of patients with nAMD, DME, and RVO treated with anti-VEGF medications
Measured: 1 Jan 2009 - 31 Dec 2024
Proportion of patients with nAMD, DME, and RVO treated with anti-VEGF medications
Measured: 1 Jan 2009 - 31 Dec 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start3 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular Degeneration (nAMD), Diabetic Macular Edema (DME), Retinal Vein Occlusion (RVO)Studies 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
- Retrospective
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308639
- Sponsor's protocol ID
- 23110
- Status last verified
- Jun 2026
- First submitted
- 17 Dec 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Individual data sharing
- No: Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. 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. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DATA-INSIGHT: Data Analysis for Treatment Assessment and Evaluation of New Sources for Evidence Generation in German Healthcare System
- ClinicalTrials.gov ID
- NCT07308639
- Acronym / sponsor ID
- 23110
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Dec 2025 (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.
The main goal of this study is to find out how common certain eye diseases are in Germany and how they have changed over time. The diseases being studied are:
nAMD (neovascular age-related macular degeneration): a condition that affects the central part of the retina and can cause vision loss in older adults.
DME (diabetic macular edema): a swelling in the central part of the retina caused by diabetes, which can also lead to vision problems.
RVO (retinal vein occlusion): a blockage of the veins in the retina, which can cause sudden vision loss.
Researchers will look at data collected from 2009 to 2024 to see how often these diseases occur (incidence) and how many people have them at a given time (prevalence). They will use two large sets of health data from Germany, called FDZ and FDGP.
The main question is: How do the numbers of new and existing cases of nAMD, DME, and RVO compare between the two data sources (FDZ and FDGP) in Germany from 2009 to 2024? The study also wants to find out if factors like age, other health problems, and medications affect how common these eye diseases are.
Another goal is to see how many people with these eye diseases are treated with a type of medicine called anti-VEGF, which is used to slow down or stop vision loss.
In summary, this study will help us understand how these eye diseases affect people in Germany, how they are treated, and whether different groups of people are more likely to get them.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| nAMD cohort | – | Drug: anti-VEGF medicationparticipants diagnosed with nAMD |
| DME cohort | – | Drug: anti-VEGF medicationparticipants diagnosed with DME |
| RVO cohort | – | Drug: anti-VEGF medicationparticipants diagnosed with RVO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all participants with the diagnosis of nAMD, DME and RVO from the FDZ and FDGP databases between 1 Jan 2009 and 31 Dec 2024
Key inclusion criteria (5 listed)
- At least one diagnosis of nAMD, DME and RVO in the timeframe 01 JAN 2009 until 31 DEC 2024
- nAMD patients aged ≥ 50 years
- DME patients aged ≥18 years
- RVO patients aged ≥18 years
- Participants living in Germany covered by statutory health insurance or private health insurance
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 |
|---|---|---|
| anti-VEGF medicationaccording to local label and treating physician | Drug | DME cohort, RVO cohort, nAMD cohort |
Primary outcome
incidence of nAMD, DME and RVO of FDZ and FDPG in Germany
Time frame: 1 Jan 2009 - 31 Dec 2024
one-year incidence rate is defined as all new patients fulfilling the inclusion and exclusion criteria in each data repository in the respective year for the first time compared to all patients in the repository in the given year.
prevalence of nAMD, DME and RVO in Germany
Time frame: 1 Jan 2009 - 31 Dec 2024
one-year prevalence rate is defined as the proportion of patients fulfilling inclusion and exclusion criteria in each data repository in the respective year PLUS patients identified in any previous year in relation to all patients in the repository in the given year.
4 secondary outcomes
incidence of nAMD, DME and RVO of FDZ and FDPG in Germany influenced by demographics, comorbidities, medications and data sources
Time frame: 1 Jan 2009 - 31 Dec 2024
prevalence of nAMD, DME and RVO of FDZ and FDPG in Germany influenced by demographics, comorbidities, medications and data sources
Time frame: 1 Jan 2009 - 31 Dec 2024
Number of patients with nAMD, DME, and RVO treated with anti-VEGF medications
Time frame: 1 Jan 2009 - 31 Dec 2024
Proportion of patients with nAMD, DME, and RVO treated with anti-VEGF medications
Time frame: 1 Jan 2009 - 31 Dec 2024
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No. Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. 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. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
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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.
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 Neovascular Age-related Macular Degeneration (nAMD), Diabetic Macular Edema (DME), Retinal Vein Occlusion (RVO), 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 5 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: looking for participants now, as of the sponsor's last update on 22 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bayer Clinical Trials Contact ((+)1-888-84 22937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of nAMD, DME and RVO of FDZ and FDPG in Germany (time frame: 1 Jan 2009 - 31 Dec 2024). The study lists 2 primary outcomes in all. 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 22 Jun 2026.