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

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

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.

Study Overview

• Status: Completed
• Conditions: Neovascular (Wet) Age-related Macular Degeneration
• Intervention / Treatment: Drug: Lucentis

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.

• Study Type: Observational
• Enrollment (Actual): 5500

Contacts and Locations

Study Locations

• Germany
  • Ahaus, Germany, 48683
    • Novartis Investigative Site
  • Andernach, Germany, 56626
    • Novartis Investigative Site
  • Augsburg, Germany, 86179
    • Novartis Investigative Site
  • Augsburg, Germany, 86150
    • Novartis Investigative Site
  • Bad Arolsen-Meneringhausen, Germany, 34454
    • Novartis Investigative Site
  • Bad Liebenzell, Germany, 75378
    • Novartis Investigative Site
  • Bad Saeckingen, Germany, 79713
    • Novartis Investigative Site
  • Baden-Baden, Germany, 76530
    • Novartis Investigative Site
  • Bautzen, Germany, 02625
    • Novartis Investigative Site
  • Beckum, Germany, 59269
    • Novartis Investigative Site
  • Berlin, Germany, 10367
    • Novartis Investigative Site
  • Berlin, Germany, 14169
    • Novartis Investigative Site
  • Berlin, Germany, 10787
    • Novartis Investigative Site
  • Berlin, Germany, 12683
    • Novartis Investigative Site
  • Berlin, Germany, 10629
    • Novartis Investigative Site
  • Berlin, Germany, 14163
    • Novartis Investigative Site
  • Berlin, Germany, 13357
    • Novartis Investigative Site
  • Berlin, Germany, 10623
    • Novartis Investigative Site
  • Berlin, Germany, 12057
    • Novartis Investigative Site
  • Bielefeld, Germany, 33602
    • Novartis Investigative Site
  • Bonn, Germany, 53177
    • Novartis Investigative Site
  • Borna, Germany, 04552
    • Novartis Investigative Site
  • Braunschweig, Germany, 38100
    • Novartis Investigative Site
  • Breisach am Rhein, Germany, 79206
    • Novartis Investigative Site
  • Bremen, Germany, 28219
    • Novartis Investigative Site
  • Bremerhaven, Germany, 27568
    • Novartis Investigative Site
  • Bremerhaven, Germany, 27578
    • Novartis Investigative Site
  • Bremervörde, Germany, 27432
    • Novartis Investigative Site
  • Brühl, Germany, 50321
    • Novartis Investigative Site
  • Buchholz, Germany, 21244
    • Novartis Investigative Site
  • Buxtehude, Germany, 21614
    • Novartis Investigative Site
  • Celle, Germany, 29221
    • Novartis Investigative Site
  • Cham, Germany, 93413
    • Novartis Investigative Site
  • Chemnitz, Germany, 09113
    • Novartis Investigative Site
  • Chemnitz, Germany, 09116
    • Novartis Investigative Site
  • Coswig, Germany, 01640
    • Novartis Investigative Site
  • Dannenberg, Germany, 29451
    • Novartis Investigative Site
  • Darmstadt, Germany, 64297
    • Novartis Investigative Site
  • Dresden, Germany, 01307
    • Novartis Investigative Site
  • Dresden, Germany, 01067
    • Novartis Investigative Site
  • Dresden, Germany, 01257
    • Novartis Investigative Site
  • Dresden, Germany, 01157
    • Novartis Investigative Site
  • Dresden, Germany, 01324
    • Novartis Investigative Site
  • Duesseldorf, Germany, 40212
    • Novartis Investigative Site
  • Düsseldorf, Germany, 40476
    • Novartis Investigative Site
  • Düsseldorf, Germany, 40625
    • Novartis Investigative Site
  • Eckental, Germany, 90542
    • Novartis Investigative Site
  • Ehingen, Germany, 89584
    • Novartis Investigative Site
  • Einbeck, Germany, 37574
    • Novartis Investigative Site
  • Erding, Germany, 85435
    • Novartis Investigative Site
  • Erkrath, Germany, 40699
    • Novartis Investigative Site
  • Esslingen, Germany, 73728
    • Novartis Investigative Site
  • Frankenthal, Germany, 67227
    • Novartis Investigative Site
  • Frankfurt, Germany, 60590
    • Novartis Investigative Site
  • Frankfurt am Main, Germany, 60596
    • Novartis Investigative Site
  • Freudenstadt, Germany, 72250
    • Novartis Investigative Site
  • Friedberg, Germany, 86316
    • Novartis Investigative Site
  • Fulda, Germany, 36037
    • Novartis Investigative Site
  • Garching, Germany, 85748
    • Novartis Investigative Site
  • Glauchau, Germany, 08371
    • Novartis Investigative Site
  • Goettingen, Germany, 37073
    • Novartis Investigative Site
  • Göttingen, Germany, 37085
    • Novartis Investigative Site
  • Gütersloh, Germany, 33330
    • Novartis Investigative Site
  • Halle, Germany, 06114
    • Novartis Investigative Site
  • Halle, Germany, 06118
    • Novartis Investigative Site
  • Hamburg, Germany, 20099
    • Novartis Investigative Site
  • Hamburg, Germany, 22391
    • Novartis Investigative Site
  • Hamburg, Germany, 22587
    • Novartis Investigative Site
  • Hamburg, Germany, 21029
    • Novartis Investigative Site
  • Hamburg, Germany, 22159
    • Novartis Investigative Site
  • Hamburg, Germany, 22529
    • Novartis Investigative Site
  • Heidelberg, Germany, 69120
    • Novartis Investigative Site
  • Heppenheim, Germany, 64646
    • Novartis Investigative Site
  • Herrsching, Germany, 82211
    • Novartis Investigative Site
  • Herzberg, Germany, 37412
    • Novartis Investigative Site
  • Homburg, Germany, 66421
    • Novartis Investigative Site
  • Hoppegarten, Germany, 15366
    • Novartis Investigative Site
  • Höhr-Grenzhausen, Germany, 56203
    • Novartis Investigative Site
  • Hösbach, Germany, 63768
    • Novartis Investigative Site
  • Juelich, Germany, 52428
    • Novartis Investigative Site
  • Kaiserslautern, Germany, 67655
    • Novartis Investigative Site
  • Karlsruhe, Germany, 76185
    • Novartis Investigative Site
  • Kempten, Germany, 87435
    • Novartis Investigative Site
  • Kiel, Germany, 24105
    • Novartis Investigative Site
  • Koblenz, Germany, 56072
    • Novartis Investigative Site
  • Koeln, Germany, 50935
    • Novartis Investigative Site
  • Leer, Germany, 26789
    • Novartis Investigative Site
  • Leipzig, Germany, 04106
    • Novartis Investigative Site
  • Leipzig, Germany, 04229
    • Novartis Investigative Site
  • Ludwigshafen, Germany, 67059
    • Novartis Investigative Site
  • Ludwigshafen, Germany, 67069
    • Novartis Investigative Site
  • Lübeck, Germany, 23538
    • Novartis Investigative Site
  • Mainz, Germany, 55131
    • Novartis Investigative Site
  • Mainz, Germany, 55116
    • Novartis Investigative Site
  • Mainz, Germany, 55124
    • Novartis Investigative Site
  • Meiben, Germany, 01662
    • Novartis Investigative Site
  • Minden, Germany, 32427
    • Novartis Investigative Site
  • Moers, Germany, 47441
    • Novartis Investigative Site
  • Muenchen, Germany, 80637
    • Novartis Investigative Site
  • Muenchen, Germany, 80377
    • Novartis Investigative Site
  • Muenster, Germany, 48145
    • Novartis Investigative Site
  • Mutterstadt, Germany, 67112
    • Novartis Investigative Site
  • München, Germany, 80335
    • Novartis Investigative Site
  • München, Germany, 81925
    • Novartis Investigative Site
  • München, Germany, 85356
    • Novartis Investigative Site
  • Münster, Germany, 48143
    • Novartis Investigative Site
  • Neu-Ulm, Germany, 89231
    • Novartis Investigative Site
  • Neubrandenburg, Germany, 17033
    • Novartis Investigative Site
  • Neubrandenburg, Germany, 17036
    • Novartis Investigative Site
  • Neustadt, Germany, 67433
    • Novartis Investigative Site
  • Neustadt A. D. Weinstraße, Germany, 67433
    • Novartis Investigative Site
  • Neutraubling, Germany, 93073
    • Novartis Investigative Site
  • Neuwied, Germany, 56564
    • Novartis Investigative Site
  • Nuernberg, Germany, 90403
    • Novartis Investigative Site
  • Obernkirchen, Germany, 31683
    • Novartis Investigative Site
  • Offenburg, Germany, 77654
    • Novartis Investigative Site
  • Oldenburg, Germany, 26121
    • Novartis Investigative Site
  • Oldenburg, Germany, 26123
    • Novartis Investigative Site
  • Osnabrück, Germany, 49076
    • Novartis Investigative Site
  • Paderborn, Germany, 33098
    • Novartis Investigative Site
  • Paderborn, Germany, 33100
    • Novartis Investigative Site
  • Peine, Germany, 31224
    • Novartis Investigative Site
  • Pfaffenhofen, Germany, 85276
    • Novartis Investigative Site
  • Pirna, Germany, 01796
    • Novartis Investigative Site
  • Plauen, Germany, 08523
    • Novartis Investigative Site
  • Polch, Germany, 56751
    • Novartis Investigative Site
  • Prien, Germany, 83209
    • Novartis Investigative Site
  • Quakenbrück, Germany, 49610
    • Novartis Investigative Site
  • Raesfeld, Germany, 46348
    • Novartis Investigative Site
  • Ratingen, Germany, 40885
    • Novartis Investigative Site
  • Regensburg, Germany, 93 047
    • Novartis Investigative Site
  • Rhauderfehn, Germany, 26817
    • Novartis Investigative Site
  • Rheine, Germany, 48429
    • Novartis Investigative Site
  • Rostock, Germany, 18057
    • Novartis Investigative Site
  • Ruesselsheim, Germany, 65428
    • Novartis Investigative Site
  • Saarbruecken, Germany, 66119
    • Novartis Investigative Site
  • Saarbrücken, Germany, 66113
    • Novartis Investigative Site
  • Saarburg, Germany, 54439
    • Novartis Investigative Site
  • Saarlouis, Germany, 66740
    • Novartis Investigative Site
  • Salzgitter, Germany, 38226
    • Novartis Investigative Site
  • Schweinfurt, Germany, 97421
    • Novartis Investigative Site
  • Siegen, Germany, 57072
    • Novartis Investigative Site
  • Sindelfingen, Germany, 71063
    • Novartis Investigative Site
  • Speyer, Germany, 67346
    • Novartis Investigative Site
  • Straubing, Germany, 94315
    • Novartis Investigative Site
  • Torgau, Germany, 04860
    • Novartis Investigative Site
  • Trier, Germany, 54290
    • Novartis Investigative Site
  • Troisdorf, Germany, 53844
    • Novartis Investigative Site
  • Tuebingen, Germany, 72076
    • Novartis Investigative Site
  • Ulm, Germany, 89073
    • Novartis Investigative Site
  • Waldshut-Tiengen, Germany, 79761
    • Novartis Investigative Site
  • Wedel, Germany, 22880
    • Novartis Investigative Site
  • Westerstede, Germany, 26655
    • Novartis Investigative Site
  • Wismar, Germany, 23966
    • Novartis Investigative Site
  • Worms, Germany, 67547
    • Novartis Investigative Site
  • Wuerzburg, Germany, 97080
    • Novartis Investigative Site
  • Baden Wuerttemberg
    • Ettlingen, Baden Wuerttemberg, Germany, 76275
      • Novartis Investigative Site
• Netherlands
  • Den Bosch, Netherlands, 5223 GZ
    • Novartis Investigative Site
  • Deventer, Netherlands, 7416 SE
    • Novartis Investigative Site
  • Rotterdam, Netherlands, 3079 DZ
    • Novartis Investigative Site
  • Rotterdam, Netherlands, 3011 BH
    • Novartis Investigative Site
  • Terneuzen, Netherlands, 4535 PA
    • Novartis Investigative Site
  • Tilburg, Netherlands, NL-5022GC
    • Novartis Investigative Site
  • Noord Brabant
    • Bergen op Zoom, Noord Brabant, Netherlands, 4611 AN
      • Novartis Investigative Site
  • Noord Holland
    • Heerhugowaard, Noord Holland, Netherlands, 1703 DC
      • Novartis Investigative Site
• Switzerland
  • Aarau, Switzerland, 5001
    • Novartis Investigative Site
  • Basel, Switzerland, 4056
    • Novartis Investigative Site
  • Basel, Switzerland, 4051
    • Novartis Investigative Site
  • Fribourg, Switzerland, 1708
    • Novartis Investigative Site
  • Geneve, Switzerland, 1205
    • Novartis Investigative Site
  • Genève, Switzerland, 1204
    • Novartis Investigative Site
  • Zurich, Switzerland, 8091
    • Novartis Investigative Site
  • BE
    • Bern, BE, Switzerland, 3011
      • Novartis Investigative Site
  • NE
    • Neuchatel, NE, Switzerland, 2000
      • Novartis Investigative Site
  • SG
    • Wil, SG, Switzerland, 9500
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lucentis; Patients administered Lucentis by prescription	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of treatments	Number of treatments will be provided	Up to 24 months
Number of visits	Number of visits will be provided	Up to 24 months
Time interval between treatments	Time interval between treatments will be provided	Up to 24 months
Time interval between visits	Time interval between visits will be provided	Up to 24 months
Duration of treatment period	Duration of treatment period will be provided	Up to 24 months
Maximum period of treatment extension	Maximum period of treatment extension (where applicable)	Up to 24 months
Number of retreatments	Number of retreatments will be provided	Up to 24 months
Reasons for retreatment	Reasons for retreatment will be provided	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.	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	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).	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	Up to 24 months

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 12, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: diabetic macular edema; Ranibizumab; Lucentis; nAMD; retinal vein occlusions; Neovascular (wet) age-related macular degeneration; choroidal neovascularizations
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: CRFB002ADE28

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO