This study is designed as an observational, non-interventional, multicenter, open label, single arm study in patients being treated with Lucentis® for any approved indication included in the local product posology.
The prospective observation period per patient will be up to 24 months. A minimum of one follow-up visit per year is required in order to maintain patient's participation in the study. The baseline visit will be used to assess eligibility and collect baseline characteristics information. The follow-up visits will take place at a frequency defined as per investigator's discretion. The study eye is defined as the first eye treated during the study, the other eye will be considered as the fellow eye. If both eyes are treated at baseline, the right eye will be chosen as the study eye.
Study Type
OBSERVATIONAL
Enrollment
5,500
There is no treatment allocation. Patients administered Lucentis by prescription that have started before inclusion of the patient into the study will be enrolled.
mean change in visual acuity
Visual acuity will be measured according to the method used by each participating physician in his/her routine practice. To be able to integrate different visual acuity assessment methods for analysis, visual acuity assessments performed using Snellen or decimal notation will be converted into an Early Treatment Diabetic Retinopathy Study (ETDRS) letter score equivalent.
Time frame: Baseline, Up to month 24
mean change in central retinal thickness
As central retinal thickness data is optional, this analysis will be performed only if data allow.
Time frame: Baseline, Up to month 24
Number of treatments
Number of treatments will be provided
Time frame: Up to 24 months
Number of visits
Number of visits will be provided
Time frame: Up to 24 months
Time interval between treatments
Time interval between treatments will be provided
Time frame: Up to 24 months
Time interval between visits
Time interval between visits will be provided
Time frame: Up to 24 months
Duration of treatment period
Duration of treatment period will be provided
Time frame: Up to 24 months
Maximum period of treatment extension
Maximum period of treatment extension (where applicable)
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Novartis Investigative Site
Ettlingen, Baden-Wurttemberg, Germany
Novartis Investigative Site
Ahaus, Germany
Novartis Investigative Site
Andernach, Germany
Novartis Investigative Site
Augsburg, Germany
Novartis Investigative Site
Augsburg, Germany
Novartis Investigative Site
Bad Arolsen-Meneringhausen, Germany
Novartis Investigative Site
Bad Liebenzell, Germany
Novartis Investigative Site
Bad Säckingen, Germany
Novartis Investigative Site
Baden-Baden, Germany
Novartis Investigative Site
Bautzen, Germany
...and 165 more locations
Time frame: Up to 24 months
Number of retreatments
Number of retreatments will be provided
Time frame: Up to 24 months
Reasons for retreatment
Reasons for retreatment will be provided
Time frame: Up to 24 months
Monitoring and treatment regimen - Therapy schemes
The following therapy schemes are defined: * Fixed scheme (FIX): Planned interval of (control-) visits: "regular" and planned treatment performance: "at each visit" * Pro Re Nata (PRN): Planned interval of (control-) visits: "regular" and planned treatment performance: "as needed" * Treat \& Extend (T+E): Planned interval of (control-) visits: "variable" and planned treatment performance: "at each visit" * Monitor \& Extend (M+E): Planned interval of (control-) visits: "variable" and planned treatment performance: "as needed" FIX, PRN, T+E and M+E are based on documentation by visit regarding physician's planning and will be applied as overall planned therapy scheme, if no different therapy schemes are documented between patient's visit. Actual interval of (control-) visits and treatment performance will be derived using the documented visit dates and treatment documentations.
Time frame: Up to 24 months
Reasons for choice of treatment regimen
Reasons for choice of treatment regimen will be provided. The choice of treatment is described within 5 categories: * Medical reasons * Compability with organisation of practice/clinic * Compability with availability of patient * Patient's request * Other
Time frame: Up to 24 months
Monitoring and treatment patterns as a function of health insurances
The results from the above derived monitoring and treatment regimen will be stratified for German patients according to the status of insurance (public health insurance or private health insurance).
Time frame: Up to 24 months
Number of treatments with Lucentis® vials and pre-filled syringe
Number of treatments with Lucentis® vials and pre-filled syringe will be provided
Time frame: Up to 24 months