Observation of Treatment Patterns With Lucentis® in Real-life Conditions in All Approved Indications

Neovascular (Wet) Age-related Macular Degeneration Clinical Trial

— PACIFIC  

Official title:

Observation of Treatment Patterns With Lucentis® (Ranibizumab) in Real-life Conditions in All Approved Indications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04847895
• Other study ID #: CRFB002ADE28
• Status: Completed
• Start date: June 1, 2015
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5500
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular (Wet) Age-related Macular Degeneration

Intervention

Drug:
• Lucentis
There is no treatment allocation. Patients administered Lucentis by prescription that have started before inclusion of the patient into the study will be enrolled.

Locations

Country	Name	City	State
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 Saeckingen
Germany	Novartis Investigative Site	Baden-Baden
Germany	Novartis Investigative Site	Bautzen
Germany	Novartis Investigative Site	Beckum
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bielefeld
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Borna
Germany	Novartis Investigative Site	Braunschweig
Germany	Novartis Investigative Site	Breisach am Rhein
Germany	Novartis Investigative Site	Bremen
Germany	Novartis Investigative Site	Bremerhaven
Germany	Novartis Investigative Site	Bremerhaven
Germany	Novartis Investigative Site	Bremervörde
Germany	Novartis Investigative Site	Brühl
Germany	Novartis Investigative Site	Buchholz
Germany	Novartis Investigative Site	Buxtehude
Germany	Novartis Investigative Site	Celle
Germany	Novartis Investigative Site	Cham
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Coswig
Germany	Novartis Investigative Site	Dannenberg
Germany	Novartis Investigative Site	Darmstadt
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Duesseldorf
Germany	Novartis Investigative Site	Düsseldorf
Germany	Novartis Investigative Site	Düsseldorf
Germany	Novartis Investigative Site	Eckental
Germany	Novartis Investigative Site	Ehingen
Germany	Novartis Investigative Site	Einbeck
Germany	Novartis Investigative Site	Erding
Germany	Novartis Investigative Site	Erkrath
Germany	Novartis Investigative Site	Esslingen
Germany	Novartis Investigative Site	Ettlingen	Baden Wuerttemberg
Germany	Novartis Investigative Site	Frankenthal
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Frankfurt am Main
Germany	Novartis Investigative Site	Freudenstadt
Germany	Novartis Investigative Site	Friedberg
Germany	Novartis Investigative Site	Fulda
Germany	Novartis Investigative Site	Garching
Germany	Novartis Investigative Site	Glauchau
Germany	Novartis Investigative Site	Goettingen
Germany	Novartis Investigative Site	Göttingen
Germany	Novartis Investigative Site	Gütersloh
Germany	Novartis Investigative Site	Halle
Germany	Novartis Investigative Site	Halle
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Heppenheim
Germany	Novartis Investigative Site	Herrsching
Germany	Novartis Investigative Site	Herzberg
Germany	Novartis Investigative Site	Höhr-Grenzhausen
Germany	Novartis Investigative Site	Homburg
Germany	Novartis Investigative Site	Hoppegarten
Germany	Novartis Investigative Site	Hösbach
Germany	Novartis Investigative Site	Juelich
Germany	Novartis Investigative Site	Kaiserslautern
Germany	Novartis Investigative Site	Karlsruhe
Germany	Novartis Investigative Site	Kempten
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigative Site	Koblenz
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Leer
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Lübeck
Germany	Novartis Investigative Site	Ludwigshafen
Germany	Novartis Investigative Site	Ludwigshafen
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Meiben
Germany	Novartis Investigative Site	Minden
Germany	Novartis Investigative Site	Moers
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	München
Germany	Novartis Investigative Site	München
Germany	Novartis Investigative Site	München
Germany	Novartis Investigative Site	Münster
Germany	Novartis Investigative Site	Mutterstadt
Germany	Novartis Investigative Site	Neu-Ulm
Germany	Novartis Investigative Site	Neubrandenburg
Germany	Novartis Investigative Site	Neubrandenburg
Germany	Novartis Investigative Site	Neustadt
Germany	Novartis Investigative Site	Neustadt A. D. Weinstraße
Germany	Novartis Investigative Site	Neutraubling
Germany	Novartis Investigative Site	Neuwied
Germany	Novartis Investigative Site	Nuernberg
Germany	Novartis Investigative Site	Obernkirchen
Germany	Novartis Investigative Site	Offenburg
Germany	Novartis Investigative Site	Oldenburg
Germany	Novartis Investigative Site	Oldenburg
Germany	Novartis Investigative Site	Osnabrück
Germany	Novartis Investigative Site	Paderborn
Germany	Novartis Investigative Site	Paderborn
Germany	Novartis Investigative Site	Peine
Germany	Novartis Investigative Site	Pfaffenhofen
Germany	Novartis Investigative Site	Pirna
Germany	Novartis Investigative Site	Plauen
Germany	Novartis Investigative Site	Polch
Germany	Novartis Investigative Site	Prien
Germany	Novartis Investigative Site	Quakenbrück
Germany	Novartis Investigative Site	Raesfeld
Germany	Novartis Investigative Site	Ratingen
Germany	Novartis Investigative Site	Regensburg
Germany	Novartis Investigative Site	Rhauderfehn
Germany	Novartis Investigative Site	Rheine
Germany	Novartis Investigative Site	Rostock
Germany	Novartis Investigative Site	Ruesselsheim
Germany	Novartis Investigative Site	Saarbrücken
Germany	Novartis Investigative Site	Saarbruecken
Germany	Novartis Investigative Site	Saarburg
Germany	Novartis Investigative Site	Saarlouis
Germany	Novartis Investigative Site	Salzgitter
Germany	Novartis Investigative Site	Schweinfurt
Germany	Novartis Investigative Site	Siegen
Germany	Novartis Investigative Site	Sindelfingen
Germany	Novartis Investigative Site	Speyer
Germany	Novartis Investigative Site	Straubing
Germany	Novartis Investigative Site	Torgau
Germany	Novartis Investigative Site	Trier
Germany	Novartis Investigative Site	Troisdorf
Germany	Novartis Investigative Site	Tuebingen
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Waldshut-Tiengen
Germany	Novartis Investigative Site	Wedel
Germany	Novartis Investigative Site	Westerstede
Germany	Novartis Investigative Site	Wismar
Germany	Novartis Investigative Site	Worms
Germany	Novartis Investigative Site	Wuerzburg
Netherlands	Novartis Investigative Site	Bergen op Zoom	Noord Brabant
Netherlands	Novartis Investigative Site	Den Bosch
Netherlands	Novartis Investigative Site	Deventer
Netherlands	Novartis Investigative Site	Heerhugowaard	Noord Holland
Netherlands	Novartis Investigative Site	Rotterdam
Netherlands	Novartis Investigative Site	Rotterdam
Netherlands	Novartis Investigative Site	Terneuzen
Netherlands	Novartis Investigative Site	Tilburg
Switzerland	Novartis Investigative Site	Aarau
Switzerland	Novartis Investigative Site	Basel
Switzerland	Novartis Investigative Site	Basel
Switzerland	Novartis Investigative Site	Bern	BE
Switzerland	Novartis Investigative Site	Fribourg
Switzerland	Novartis Investigative Site	Geneve
Switzerland	Novartis Investigative Site	Genève
Switzerland	Novartis Investigative Site	Neuchatel	NE
Switzerland	Novartis Investigative Site	Wil	SG
Switzerland	Novartis Investigative Site	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Germany,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Up to month 24
Primary	mean change in central retinal thickness	As central retinal thickness data is optional, this analysis will be performed only if data allow.	Baseline, Up to month 24
Secondary	Number of treatments	Number of treatments will be provided	Up to 24 months
Secondary	Number of visits	Number of visits will be provided	Up to 24 months
Secondary	Time interval between treatments	Time interval between treatments will be provided	Up to 24 months
Secondary	Time interval between visits	Time interval between visits will be provided	Up to 24 months
Secondary	Duration of treatment period	Duration of treatment period will be provided	Up to 24 months
Secondary	Maximum period of treatment extension	Maximum period of treatment extension (where applicable)	Up to 24 months
Secondary	Number of retreatments	Number of retreatments will be provided	Up to 24 months
Secondary	Reasons for retreatment	Reasons for retreatment will be provided	Up to 24 months
Secondary	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.	Up to 24 months
Secondary	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	Up to 24 months
Secondary	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).	Up to 24 months
Secondary	Number of treatments with Lucentis® vials and pre-filled syringe	Number of treatments with Lucentis® vials and pre-filled syringe will be provided	Up to 24 months