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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: anti-VEGF medication.
- Who it may be relevant to
- Registry conditions: Neovascular Age-related Macular Degeneration (nAMD), Diabetic Macular Edema (DME), Retinal Vein Occlusion (RVO). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
DATA-INSIGHT: Data Analysis for Treatment Assessment and Evaluation of New Sources for Evidence Generation in German Healthcare System
Overview
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.
Interventions
- Drug anti-VEGF medication
according to local label and treating physician
Primary outcome measures
- incidence of nAMD, DME and RVO of FDZ and FDPG in Germany [Time frame: 1 Jan 2009 - 31 Dec 2024]
- prevalence of nAMD, DME and RVO in Germany [Time frame: 1 Jan 2009 - 31 Dec 2024]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- none
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Bayer Vital GmbH — Leverkusen
Identifiers
NCT: NCT07308639 · 23110