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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT04847895
Collaborator
(none)
5,500
Enrollment
175
Locations
70
Actual Duration (Months)
31.4
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Actual Enrollment :
5500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Observation of Treatment Patterns With Lucentis® (Ranibizumab) in Real-life Conditions in All Approved Indications
Actual Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Mar 31, 2021
Actual Study Completion Date :
Mar 31, 2021

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. mean change in visual acuity [Baseline, Up to month 24]

    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.

  2. mean change in central retinal thickness [Baseline, Up to month 24]

    As central retinal thickness data is optional, this analysis will be performed only if data allow.

Secondary Outcome Measures

  1. Number of treatments [Up to 24 months]

    Number of treatments will be provided

  2. Number of visits [Up to 24 months]

    Number of visits will be provided

  3. Time interval between treatments [Up to 24 months]

    Time interval between treatments will be provided

  4. Time interval between visits [Up to 24 months]

    Time interval between visits will be provided

  5. Duration of treatment period [Up to 24 months]

    Duration of treatment period will be provided

  6. Maximum period of treatment extension [Up to 24 months]

    Maximum period of treatment extension (where applicable)

  7. Number of retreatments [Up to 24 months]

    Number of retreatments will be provided

  8. Reasons for retreatment [Up to 24 months]

    Reasons for retreatment will be provided

  9. Monitoring and treatment regimen - Therapy schemes [Up to 24 months]

    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.

  10. Reasons for choice of treatment regimen [Up to 24 months]

    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

  11. Monitoring and treatment patterns as a function of health insurances [Up to 24 months]

    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).

  12. Number of treatments with Lucentis® vials and pre-filled syringe [Up to 24 months]

    Number of treatments with Lucentis® vials and pre-filled syringe will be provided

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novartis Investigative Site Ettlingen Baden Wuerttemberg Germany 76275
2 Novartis Investigative Site Ahaus Germany 48683
3 Novartis Investigative Site Andernach Germany 56626
4 Novartis Investigative Site Augsburg Germany 86150
5 Novartis Investigative Site Augsburg Germany 86179
6 Novartis Investigative Site Bad Arolsen-Meneringhausen Germany 34454
7 Novartis Investigative Site Bad Liebenzell Germany 75378
8 Novartis Investigative Site Bad Saeckingen Germany 79713
9 Novartis Investigative Site Baden-Baden Germany 76530
10 Novartis Investigative Site Bautzen Germany 02625
11 Novartis Investigative Site Beckum Germany 59269
12 Novartis Investigative Site Berlin Germany 10367
13 Novartis Investigative Site Berlin Germany 10623
14 Novartis Investigative Site Berlin Germany 10629
15 Novartis Investigative Site Berlin Germany 10787
16 Novartis Investigative Site Berlin Germany 12057
17 Novartis Investigative Site Berlin Germany 12683
18 Novartis Investigative Site Berlin Germany 13357
19 Novartis Investigative Site Berlin Germany 14163
20 Novartis Investigative Site Berlin Germany 14169
21 Novartis Investigative Site Bielefeld Germany 33602
22 Novartis Investigative Site Bonn Germany 53177
23 Novartis Investigative Site Borna Germany 04552
24 Novartis Investigative Site Braunschweig Germany 38100
25 Novartis Investigative Site Breisach am Rhein Germany 79206
26 Novartis Investigative Site Bremen Germany 28219
27 Novartis Investigative Site Bremerhaven Germany 27568
28 Novartis Investigative Site Bremerhaven Germany 27578
29 Novartis Investigative Site Bremervörde Germany 27432
30 Novartis Investigative Site Brühl Germany 50321
31 Novartis Investigative Site Buchholz Germany 21244
32 Novartis Investigative Site Buxtehude Germany 21614
33 Novartis Investigative Site Celle Germany 29221
34 Novartis Investigative Site Cham Germany 93413
35 Novartis Investigative Site Chemnitz Germany 09113
36 Novartis Investigative Site Chemnitz Germany 09116
37 Novartis Investigative Site Coswig Germany 01640
38 Novartis Investigative Site Dannenberg Germany 29451
39 Novartis Investigative Site Darmstadt Germany 64297
40 Novartis Investigative Site Dresden Germany 01067
41 Novartis Investigative Site Dresden Germany 01157
42 Novartis Investigative Site Dresden Germany 01257
43 Novartis Investigative Site Dresden Germany 01307
44 Novartis Investigative Site Dresden Germany 01324
45 Novartis Investigative Site Duesseldorf Germany 40212
46 Novartis Investigative Site Düsseldorf Germany 40476
47 Novartis Investigative Site Düsseldorf Germany 40625
48 Novartis Investigative Site Eckental Germany 90542
49 Novartis Investigative Site Ehingen Germany 89584
50 Novartis Investigative Site Einbeck Germany 37574
51 Novartis Investigative Site Erding Germany 85435
52 Novartis Investigative Site Erkrath Germany 40699
53 Novartis Investigative Site Esslingen Germany 73728
54 Novartis Investigative Site Frankenthal Germany 67227
55 Novartis Investigative Site Frankfurt am Main Germany 60596
56 Novartis Investigative Site Frankfurt Germany 60590
57 Novartis Investigative Site Freudenstadt Germany 72250
58 Novartis Investigative Site Friedberg Germany 86316
59 Novartis Investigative Site Fulda Germany 36037
60 Novartis Investigative Site Garching Germany 85748
61 Novartis Investigative Site Glauchau Germany 08371
62 Novartis Investigative Site Goettingen Germany 37073
63 Novartis Investigative Site Göttingen Germany 37085
64 Novartis Investigative Site Gütersloh Germany 33330
65 Novartis Investigative Site Halle Germany 06114
66 Novartis Investigative Site Halle Germany 06118
67 Novartis Investigative Site Hamburg Germany 20099
68 Novartis Investigative Site Hamburg Germany 21029
69 Novartis Investigative Site Hamburg Germany 22159
70 Novartis Investigative Site Hamburg Germany 22391
71 Novartis Investigative Site Hamburg Germany 22529
72 Novartis Investigative Site Hamburg Germany 22587
73 Novartis Investigative Site Heidelberg Germany 69120
74 Novartis Investigative Site Heppenheim Germany 64646
75 Novartis Investigative Site Herrsching Germany 82211
76 Novartis Investigative Site Herzberg Germany 37412
77 Novartis Investigative Site Homburg Germany 66421
78 Novartis Investigative Site Hoppegarten Germany 15366
79 Novartis Investigative Site Höhr-Grenzhausen Germany 56203
80 Novartis Investigative Site Hösbach Germany 63768
81 Novartis Investigative Site Juelich Germany 52428
82 Novartis Investigative Site Kaiserslautern Germany 67655
83 Novartis Investigative Site Karlsruhe Germany 76185
84 Novartis Investigative Site Kempten Germany 87435
85 Novartis Investigative Site Kiel Germany 24105
86 Novartis Investigative Site Koblenz Germany 56072
87 Novartis Investigative Site Koeln Germany 50935
88 Novartis Investigative Site Leer Germany 26789
89 Novartis Investigative Site Leipzig Germany 04106
90 Novartis Investigative Site Leipzig Germany 04229
91 Novartis Investigative Site Ludwigshafen Germany 67059
92 Novartis Investigative Site Ludwigshafen Germany 67069
93 Novartis Investigative Site Lübeck Germany 23538
94 Novartis Investigative Site Mainz Germany 55116
95 Novartis Investigative Site Mainz Germany 55124
96 Novartis Investigative Site Mainz Germany 55131
97 Novartis Investigative Site Meiben Germany 01662
98 Novartis Investigative Site Minden Germany 32427
99 Novartis Investigative Site Moers Germany 47441
100 Novartis Investigative Site Muenchen Germany 80377
101 Novartis Investigative Site Muenchen Germany 80637
102 Novartis Investigative Site Muenster Germany 48145
103 Novartis Investigative Site Mutterstadt Germany 67112
104 Novartis Investigative Site München Germany 80335
105 Novartis Investigative Site München Germany 81925
106 Novartis Investigative Site München Germany 85356
107 Novartis Investigative Site Münster Germany 48143
108 Novartis Investigative Site Neu-Ulm Germany 89231
109 Novartis Investigative Site Neubrandenburg Germany 17033
110 Novartis Investigative Site Neubrandenburg Germany 17036
111 Novartis Investigative Site Neustadt A. D. Weinstraße Germany 67433
112 Novartis Investigative Site Neustadt Germany 67433
113 Novartis Investigative Site Neutraubling Germany 93073
114 Novartis Investigative Site Neuwied Germany 56564
115 Novartis Investigative Site Nuernberg Germany 90403
116 Novartis Investigative Site Obernkirchen Germany 31683
117 Novartis Investigative Site Offenburg Germany 77654
118 Novartis Investigative Site Oldenburg Germany 26121
119 Novartis Investigative Site Oldenburg Germany 26123
120 Novartis Investigative Site Osnabrück Germany 49076
121 Novartis Investigative Site Paderborn Germany 33098
122 Novartis Investigative Site Paderborn Germany 33100
123 Novartis Investigative Site Peine Germany 31224
124 Novartis Investigative Site Pfaffenhofen Germany 85276
125 Novartis Investigative Site Pirna Germany 01796
126 Novartis Investigative Site Plauen Germany 08523
127 Novartis Investigative Site Polch Germany 56751
128 Novartis Investigative Site Prien Germany 83209
129 Novartis Investigative Site Quakenbrück Germany 49610
130 Novartis Investigative Site Raesfeld Germany 46348
131 Novartis Investigative Site Ratingen Germany 40885
132 Novartis Investigative Site Regensburg Germany 93 047
133 Novartis Investigative Site Rhauderfehn Germany 26817
134 Novartis Investigative Site Rheine Germany 48429
135 Novartis Investigative Site Rostock Germany 18057
136 Novartis Investigative Site Ruesselsheim Germany 65428
137 Novartis Investigative Site Saarbruecken Germany 66119
138 Novartis Investigative Site Saarbrücken Germany 66113
139 Novartis Investigative Site Saarburg Germany 54439
140 Novartis Investigative Site Saarlouis Germany 66740
141 Novartis Investigative Site Salzgitter Germany 38226
142 Novartis Investigative Site Schweinfurt Germany 97421
143 Novartis Investigative Site Siegen Germany 57072
144 Novartis Investigative Site Sindelfingen Germany 71063
145 Novartis Investigative Site Speyer Germany 67346
146 Novartis Investigative Site Straubing Germany 94315
147 Novartis Investigative Site Torgau Germany 04860
148 Novartis Investigative Site Trier Germany 54290
149 Novartis Investigative Site Troisdorf Germany 53844
150 Novartis Investigative Site Tuebingen Germany 72076
151 Novartis Investigative Site Ulm Germany 89073
152 Novartis Investigative Site Waldshut-Tiengen Germany 79761
153 Novartis Investigative Site Wedel Germany 22880
154 Novartis Investigative Site Westerstede Germany 26655
155 Novartis Investigative Site Wismar Germany 23966
156 Novartis Investigative Site Worms Germany 67547
157 Novartis Investigative Site Wuerzburg Germany 97080
158 Novartis Investigative Site Bergen op Zoom Noord Brabant Netherlands 4611 AN
159 Novartis Investigative Site Heerhugowaard Noord Holland Netherlands 1703 DC
160 Novartis Investigative Site Den Bosch Netherlands 5223 GZ
161 Novartis Investigative Site Deventer Netherlands 7416 SE
162 Novartis Investigative Site Rotterdam Netherlands 3011 BH
163 Novartis Investigative Site Rotterdam Netherlands 3079 DZ
164 Novartis Investigative Site Terneuzen Netherlands 4535 PA
165 Novartis Investigative Site Tilburg Netherlands NL-5022GC
166 Novartis Investigative Site Bern BE Switzerland 3011
167 Novartis Investigative Site Neuchatel NE Switzerland 2000
168 Novartis Investigative Site Wil SG Switzerland 9500
169 Novartis Investigative Site Aarau Switzerland 5001
170 Novartis Investigative Site Basel Switzerland 4051
171 Novartis Investigative Site Basel Switzerland 4056
172 Novartis Investigative Site Fribourg Switzerland 1708
173 Novartis Investigative Site Geneve Switzerland 1205
174 Novartis Investigative Site Genève Switzerland 1204
175 Novartis Investigative Site Zurich Switzerland 8091

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT04847895
Other Study ID Numbers:
  • CRFB002ADE28
First Posted:
Apr 19, 2021
Last Update Posted:
Apr 19, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Novartis Pharmaceuticals
Lucentis
Ranibizumab
Neovascular (wet) age-related macular degeneration
nAMD
diabetic macular edema
retinal vein occlusions
choroidal neovascularizations
Additional relevant MeSH terms:
Macular Degeneration
Ranibizumab

Study Results

No Results Posted as of Apr 19, 2021