Study type

Study topic

DiseaseĀ /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation

Data collection methods

Secondary data collection
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

Pharmacoepidemiological study
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(L01XC07) bevacizumab
(S01CB01) dexamethasone
(S01LA03) pegaptanib
(S01LA04) ranibizumab
(S01LA05) aflibercept

Medical condition to be studied

Diabetic retinopathy
Diabetic retinal oedema
Age-related macular degeneration
Population studied

Short description of the study population

Patients with diabetic retinopathy, retinal oedema or age-related macular degeneration in the Tuscany region of Italy, from 2011 to 2015.

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Other

Special population of interest, other

Patients with diabetic retinopathy, retinal oedema or age-related macular degeneration

Estimated number of subjects

15000
Study design details

Main study objective

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

Outcomes

Number of injections per year and intra-injections interval, switchingless than 5 injections in the first year

Data analysis plan

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
Documents
Study results
English (213.74 KB - PDF)View document