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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04847895
Other study ID # CRFB002ADE28
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
See also
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Active, not recruiting NCT05439629 - Efficacy Evaluation Study of BAT5906 and Lucentis® in Patients With Macular Degeneration Phase 3
Recruiting NCT05197270 - 4D-150 in Patients With Neovascular (Wet) Age-Related Macular Degeneration Phase 1/Phase 2
Terminated NCT05473715 - A Study to Learn How Well Aflibercept Injected Into the Eye Works and How Safe it is When Given in Customized Treatment Intervals in Patients With an Eye Disease Called Neovascular Age-related Macular Degeneration After Start of Treatment Phase 4
Recruiting NCT06346600 - A Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients With nAMD