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.

NCT ID: NCT07308639

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Neovascular Age-related Macular Degeneration (nAMD); Diabetic Macular Edema (DME); Retinal Vein Occlusion (RVO)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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nAMD cohort

participants diagnosed with nAMD

anti-VEGF medication

Intervention Type DRUG

according to local label and treating physician

DME cohort

participants diagnosed with DME

anti-VEGF medication

Intervention Type DRUG

according to local label and treating physician

RVO cohort

participants diagnosed with RVO

anti-VEGF medication

Intervention Type DRUG

according to local label and treating physician

Interventions

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anti-VEGF medication

according to local label and treating physician

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bayer Vital GmbH

Leverkusen, , Germany

Site Status

Countries

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Germany

Central Contacts

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Bayer Clinical Trials Contact

Role: CONTACT

Phone: (+)1-888-84 22937

Email: [email protected]

Other Identifiers

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23110

Identifier Type: -

Identifier Source: org_study_id