Status: Finalised
First registered on:
08/10/2016
Last updated on:
28/11/2016
1. Study identification
EU PAS Register NumberEUPAS15749
Official titlePattern of use of intravitreal drugs with antiangiogenic properties for age-related macular degeneration and other vascular retinopathies
Study title acronymAnti-VEGF drugs
Study typeObservational study
Brief description of the studyThis is a drug utilization study of antiVEGF drugs for the treatment of age related macular degeneration and other vascular retinopathies in clinical practice, in the Tuscany region of Italy, from 2011 to 2015
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsARS
Department/Research groupOsservatorio di Epidemiologia
Organisation/affiliationAgenzia regionale di sanità della Toscana (ARS)
Details of (Primary) lead investigator
Title Dr
Last name Gini
First name Rosa
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
National study
Italy
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed09/03/201603/03/2016
Start date of data collection05/09/201605/09/2016
Start date of data analysis12/09/201612/09/2016
Date of interim report, if expected
Date of final study report17/10/201628/11/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
Otherself-funded by ARS100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Gini
First name Rosa
Address line 1Via Pietro Dazzi 1
Address line 250141
Address line 3
CityFlorence
Postcode50141
CountryItaly
Phone number (incl. country code)39-0554624341
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Gini
First name Rosa
Address line 1Via Pietro Dazzi 1
Address line 250141
Address line 3
CityFlorence
Postcode50141
CountryItaly
Phone number (incl. country code)39-0554624341
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Substance class (ATC Code)S01LA05 (aflibercept)
Substance class (ATC Code)L01XC07 (bevacizumab)
Substance class (ATC Code)S01LA04 (ranibizumab)
Substance class (ATC Code)S01LA03 (pegaptanib)
Substance class (ATC Code)S01CB01 (dexamethasone)
7. Medical conditions to be studied
Medical condition(s)Yes
Diabetic retinopathy
Diabetic retinal oedema
Age-related macular degeneration
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects15000
Additional information
Ranibizumab, bevacizumab and pagaptanib were already available in 2011. Dexamethasone started in 2012 and aflibercept in 2013.
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Sources of data
Administrative database, e.g. claims database
Pharmacy dispensing records
disease-specific exemptions from copayment
11. Scope of the study
What is the scope of the study?
Drug utilisation study
Primary scope : Drug utilisation study
12. Main objective(s)
What is the main objective of the study?
To describe the pattern of use of anti-VEGF drugs for the treatment of age-related macular degeneration and other vascular retinopathies in clinical practice in Tuscany, Italy
Are there primary outcomes?Yes
Number of injections per year and intra-injections interval
Are there secondary outcomes?Yes
switching
less than 5 injections in the first year
13. Study design
What is the design of the study?
Drug utilisation study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
1 to 3 years per patient
15. Data analysis plan
Please provide a brief summary of the analysis method
Outcomes will be compared across incident users of the drugs. Subgroup analysis will be performed in patients with a sufficient number of contacts with ophthalmic services (interval between consecutive contacts not longer than 3 months) and in patient with at least 3 injections
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
