Clinical trial NCT04847895: Observation of Treatment Patterns With Lucentis® in Real-life Conditions in All Approved Indications
Official title: Observation of Treatment Patterns With Lucentis® (Ranibizumab) in Real-life Conditions in All Approved Indications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neovascular (Wet) Age-related Macular Degeneration
Keywords: Lucentis
Ranibizumab
Neovascular (wet) age-related macular degeneration
nAMD
diabetic macular edema
retinal vein occlusions
choroidal neovascularizations
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-04-19
Enrollment: 5500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients being treated with Lucentis® for any approved indication included in the local product posology. Patients will be enrolled from approximately 211 centers across Europe.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Male or female patients, ≥18 years of age, being treated with Lucentis® for any approved indication in the local Lucentis® SmPC
* Written informed consent

Exclusion Criteria:

* As described in Lucentis® SmPC
* Participation in any other clinical study or NIS with Lucentis® as the investigational drug (such as OCEAN or LUMINOUS)

Primary outcomes:
measure: mean change in visual acuity
timeFrame: Baseline, Up to month 24
measure: mean change in central retinal thickness
timeFrame: Baseline, Up to month 24
Secondary outcomes:
measure: Number of treatments
timeFrame: Up to 24 months
measure: Number of visits
timeFrame: Up to 24 months
measure: Time interval between treatments
timeFrame: Up to 24 months
measure: Time interval between visits
timeFrame: Up to 24 months
measure: Duration of treatment period
timeFrame: Up to 24 months
measure: Maximum period of treatment extension
timeFrame: Up to 24 months
measure: Number of retreatments
timeFrame: Up to 24 months
measure: Reasons for retreatment
timeFrame: Up to 24 months
measure: Monitoring and treatment regimen - Therapy schemes
timeFrame: Up to 24 months
measure: Reasons for choice of treatment regimen
timeFrame: Up to 24 months
measure: Monitoring and treatment patterns as a function of health insurances
timeFrame: Up to 24 months
measure: Number of treatments with Lucentis® vials and pre-filled syringe
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Ettlingen
country: Germany
facility: Novartis Investigative Site
state: Baden Wuerttemberg
city: Ahaus
country: Germany
facility: Novartis Investigative Site
city: Andernach
country: Germany
facility: Novartis Investigative Site
city: Augsburg
country: Germany
facility: Novartis Investigative Site
city: Augsburg
country: Germany
facility: Novartis Investigative Site
city: Bad Arolsen-Meneringhausen
country: Germany
facility: Novartis Investigative Site
city: Bad Liebenzell
country: Germany
facility: Novartis Investigative Site
city: Bad Saeckingen
country: Germany
facility: Novartis Investigative Site
city: Baden-Baden
country: Germany
facility: Novartis Investigative Site
city: Bautzen
country: Germany
facility: Novartis Investigative Site
city: Beckum
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bielefeld
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Borna
country: Germany
facility: Novartis Investigative Site
city: Braunschweig
country: Germany
facility: Novartis Investigative Site
city: Breisach am Rhein
country: Germany
facility: Novartis Investigative Site
city: Bremen
country: Germany
facility: Novartis Investigative Site
city: Bremerhaven
country: Germany
facility: Novartis Investigative Site
city: Bremerhaven
country: Germany
facility: Novartis Investigative Site
city: Bremervörde
country: Germany
facility: Novartis Investigative Site
city: Brühl
country: Germany
facility: Novartis Investigative Site
city: Buchholz
country: Germany
facility: Novartis Investigative Site
city: Buxtehude
country: Germany
facility: Novartis Investigative Site
city: Celle
country: Germany
facility: Novartis Investigative Site
city: Cham
country: Germany
facility: Novartis Investigative Site
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
city: Coswig
country: Germany
facility: Novartis Investigative Site
city: Dannenberg
country: Germany
facility: Novartis Investigative Site
city: Darmstadt
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
city: Düsseldorf
country: Germany
facility: Novartis Investigative Site
city: Düsseldorf
country: Germany
facility: Novartis Investigative Site
city: Eckental
country: Germany
facility: Novartis Investigative Site
city: Ehingen
country: Germany
facility: Novartis Investigative Site
city: Einbeck
country: Germany
facility: Novartis Investigative Site
city: Erding
country: Germany
facility: Novartis Investigative Site
city: Erkrath
country: Germany
facility: Novartis Investigative Site
city: Esslingen
country: Germany
facility: Novartis Investigative Site
city: Frankenthal
country: Germany
facility: Novartis Investigative Site
city: Frankfurt am Main
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Freudenstadt
country: Germany
facility: Novartis Investigative Site
city: Friedberg
country: Germany
facility: Novartis Investigative Site
city: Fulda
country: Germany
facility: Novartis Investigative Site
city: Garching
country: Germany
facility: Novartis Investigative Site
city: Glauchau
country: Germany
facility: Novartis Investigative Site
city: Goettingen
country: Germany
facility: Novartis Investigative Site
city: Göttingen
country: Germany
facility: Novartis Investigative Site
city: Gütersloh
country: Germany
facility: Novartis Investigative Site
city: Halle
country: Germany
facility: Novartis Investigative Site
city: Halle
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Heppenheim
country: Germany
facility: Novartis Investigative Site
city: Herrsching
country: Germany
facility: Novartis Investigative Site
city: Herzberg
country: Germany
facility: Novartis Investigative Site
city: Homburg
country: Germany
facility: Novartis Investigative Site
city: Hoppegarten
country: Germany
facility: Novartis Investigative Site
city: Höhr-Grenzhausen
country: Germany
facility: Novartis Investigative Site
city: Hösbach
country: Germany
facility: Novartis Investigative Site
city: Juelich
country: Germany
facility: Novartis Investigative Site
city: Kaiserslautern
country: Germany
facility: Novartis Investigative Site
city: Karlsruhe
country: Germany
facility: Novartis Investigative Site
city: Kempten
country: Germany
facility: Novartis Investigative Site
city: Kiel
country: Germany
facility: Novartis Investigative Site
city: Koblenz
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Leer
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Ludwigshafen
country: Germany
facility: Novartis Investigative Site
city: Ludwigshafen
country: Germany
facility: Novartis Investigative Site
city: Lübeck
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Meiben
country: Germany
facility: Novartis Investigative Site
city: Minden
country: Germany
facility: Novartis Investigative Site
city: Moers
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Mutterstadt
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: Münster
country: Germany
facility: Novartis Investigative Site
city: Neu-Ulm
country: Germany
facility: Novartis Investigative Site
city: Neubrandenburg
country: Germany
facility: Novartis Investigative Site
city: Neubrandenburg
country: Germany
facility: Novartis Investigative Site
city: Neustadt A. D. Weinstraße
country: Germany
facility: Novartis Investigative Site
city: Neustadt
country: Germany
facility: Novartis Investigative Site
city: Neutraubling
country: Germany
facility: Novartis Investigative Site
city: Neuwied
country: Germany
facility: Novartis Investigative Site
city: Nuernberg
country: Germany
facility: Novartis Investigative Site
city: Obernkirchen
country: Germany
facility: Novartis Investigative Site
city: Offenburg
country: Germany
facility: Novartis Investigative Site
city: Oldenburg
country: Germany
facility: Novartis Investigative Site
city: Oldenburg
country: Germany
facility: Novartis Investigative Site
city: Osnabrück
country: Germany
facility: Novartis Investigative Site
city: Paderborn
country: Germany
facility: Novartis Investigative Site
city: Paderborn
country: Germany
facility: Novartis Investigative Site
city: Peine
country: Germany
facility: Novartis Investigative Site
city: Pfaffenhofen
country: Germany
facility: Novartis Investigative Site
city: Pirna
country: Germany
facility: Novartis Investigative Site
city: Plauen
country: Germany
facility: Novartis Investigative Site
city: Polch
country: Germany
facility: Novartis Investigative Site
city: Prien
country: Germany
facility: Novartis Investigative Site
city: Quakenbrück
country: Germany
facility: Novartis Investigative Site
city: Raesfeld
country: Germany
facility: Novartis Investigative Site
city: Ratingen
country: Germany
facility: Novartis Investigative Site
city: Regensburg
country: Germany
facility: Novartis Investigative Site
city: Rhauderfehn
country: Germany
facility: Novartis Investigative Site
city: Rheine
country: Germany
facility: Novartis Investigative Site
city: Rostock
country: Germany
facility: Novartis Investigative Site
city: Ruesselsheim
country: Germany
facility: Novartis Investigative Site
city: Saarbruecken
country: Germany
facility: Novartis Investigative Site
city: Saarbrücken
country: Germany
facility: Novartis Investigative Site
city: Saarburg
country: Germany
facility: Novartis Investigative Site
city: Saarlouis
country: Germany
facility: Novartis Investigative Site
city: Salzgitter
country: Germany
facility: Novartis Investigative Site
city: Schweinfurt
country: Germany
facility: Novartis Investigative Site
city: Siegen
country: Germany
facility: Novartis Investigative Site
city: Sindelfingen
country: Germany
facility: Novartis Investigative Site
city: Speyer
country: Germany
facility: Novartis Investigative Site
city: Straubing
country: Germany
facility: Novartis Investigative Site
city: Torgau
country: Germany
facility: Novartis Investigative Site
city: Trier
country: Germany
facility: Novartis Investigative Site
city: Troisdorf
country: Germany
facility: Novartis Investigative Site
city: Tuebingen
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Waldshut-Tiengen
country: Germany
facility: Novartis Investigative Site
city: Wedel
country: Germany
facility: Novartis Investigative Site
city: Westerstede
country: Germany
facility: Novartis Investigative Site
city: Wismar
country: Germany
facility: Novartis Investigative Site
city: Worms
country: Germany
facility: Novartis Investigative Site
city: Wuerzburg
country: Germany
facility: Novartis Investigative Site
city: Bergen op Zoom
country: Netherlands
facility: Novartis Investigative Site
state: Noord Brabant
city: Heerhugowaard
country: Netherlands
facility: Novartis Investigative Site
state: Noord Holland
city: Den Bosch
country: Netherlands
facility: Novartis Investigative Site
city: Deventer
country: Netherlands
facility: Novartis Investigative Site
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
city: Terneuzen
country: Netherlands
facility: Novartis Investigative Site
city: Tilburg
country: Netherlands
facility: Novartis Investigative Site
city: Bern
country: Switzerland
facility: Novartis Investigative Site
state: BE
city: Neuchatel
country: Switzerland
facility: Novartis Investigative Site
state: NE
city: Wil
country: Switzerland
facility: Novartis Investigative Site
state: SG
city: Aarau
country: Switzerland
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Fribourg
country: Switzerland
facility: Novartis Investigative Site
city: Geneve
country: Switzerland
facility: Novartis Investigative Site
city: Genève
country: Switzerland
facility: Novartis Investigative Site
city: Zurich
country: Switzerland
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: