Neovascular (Wet) Age-related Macular DegenerationPACIFICNCT04847895
Observation of Treatment Patterns With Lucentis® in Real-life Conditions in All Approved Indications
An observational study of Neovascular (Wet) Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 175 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neovascular (Wet) Age-related Macular Degeneration
- What is being tested?
- Lucentis
- How many people
- 5,500 participants
- Where
- 175 sitesin 3 countries
- Study dates
- 1 Jun 2015to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Male or female patients, ≥18 years of age, being treated with Lucentis® for any approved indication in the local Lucentis® SmPC
- Written informed consent
Who cannot join
- As described in Lucentis® SmPC
- Participation in any other clinical study or NIS with Lucentis® as the investigational drug (such as OCEAN or LUMINOUS)
Trial locations and contacts
175 sites in 3 countries.
175 sites in 3 countries
Germany157 sites
Novartis Investigative Site
Ahaus, 48683
Novartis Investigative Site
Andernach, 56626
Novartis Investigative Site
Augsburg, 86150
Novartis Investigative Site
Augsburg, 86179
Novartis Investigative Site
Bad Arolsen-Meneringhausen, 34454
Novartis Investigative Site
Bad Liebenzell, 75378
Novartis Investigative Site
Bad Säckingen, 79713
Novartis Investigative Site
Baden-Baden, 76530
Novartis Investigative Site
Bautzen, 02625
Novartis Investigative Site
Beckum, 59269
Novartis Investigative Site
Berlin, 10367
Novartis Investigative Site
Berlin, 10623
Novartis Investigative Site
Berlin, 10629
Novartis Investigative Site
Berlin, 10787
Novartis Investigative Site
Berlin, 12057
Novartis Investigative Site
Berlin, 12683
Novartis Investigative Site
Berlin, 13357
Novartis Investigative Site
Berlin, 14163
Novartis Investigative Site
Berlin, 14169
Novartis Investigative Site
Bielefeld, 33602
Novartis Investigative Site
Bonn, 53177
Novartis Investigative Site
Borna, 04552
Novartis Investigative Site
Braunschweig, 38100
Novartis Investigative Site
Breisach, 79206
Novartis Investigative Site
Bremen, 28219
Novartis Investigative Site
Bremerhaven, 27568
Novartis Investigative Site
Bremerhaven, 27578
Novartis Investigative Site
Bremervörde, 27432
Novartis Investigative Site
Brühl, 50321
Novartis Investigative Site
Buchholz, 21244
Novartis Investigative Site
Buxtehude, 21614
Novartis Investigative Site
Celle, 29221
Novartis Investigative Site
Cham, 93413
Novartis Investigative Site
Chemnitz, 09113
Novartis Investigative Site
Chemnitz, 09116
Novartis Investigative Site
Cologne, 50935
Novartis Investigative Site
Coswig, 01640
Novartis Investigative Site
Dannenberg, 29451
Novartis Investigative Site
Darmstadt, 64297
Novartis Investigative Site
Dresden, 01067
Novartis Investigative Site
Dresden, 01157
Novartis Investigative Site
Dresden, 01257
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Dresden, 01324
Novartis Investigative Site
Düsseldorf, 40212
Novartis Investigative Site
Düsseldorf, 40476
Novartis Investigative Site
Düsseldorf, 40625
Novartis Investigative Site
Eckental, 90542
Novartis Investigative Site
Ehingen, 89584
Novartis Investigative Site
Einbeck, 37574
Novartis Investigative Site
Erding, 85435
Novartis Investigative Site
Erkrath, 40699
Novartis Investigative Site
Esslingen am Neckar, 73728
Novartis Investigative Site
Ettlingen, Baden-Wurttemberg, 76275
Novartis Investigative Site
Frankenthal, 67227
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Frankfurt am Main, 60596
Novartis Investigative Site
Freudenstadt, 72250
Novartis Investigative Site
Friedberg, 86316
Novartis Investigative Site
Fulda, 36037
Novartis Investigative Site
Garching, 85748
Novartis Investigative Site
Glauchau, 08371
Novartis Investigative Site
Göttingen, 37073
Novartis Investigative Site
Göttingen, 37085
Novartis Investigative Site
Gütersloh, 33330
Novartis Investigative Site
Halle, 06114
Novartis Investigative Site
Halle, 06118
Novartis Investigative Site
Hamburg, 20099
Novartis Investigative Site
Hamburg, 21029
Novartis Investigative Site
Hamburg, 22159
Novartis Investigative Site
Hamburg, 22391
Novartis Investigative Site
Hamburg, 22529
Novartis Investigative Site
Hamburg, 22587
Novartis Investigative Site
Heidelberg, 69120
Novartis Investigative Site
Heppenheim an der Bergstrasse, 64646
Novartis Investigative Site
Herrsching am Ammersee, 82211
Novartis Investigative Site
Herzberg, 37412
Novartis Investigative Site
Höhr-Grenzhausen, 56203
Novartis Investigative Site
Homburg, 66421
Novartis Investigative Site
Hoppegarten, 15366
Novartis Investigative Site
Hösbach, 63768
Novartis Investigative Site
Jülich, 52428
Novartis Investigative Site
Kaiserslautern, 67655
Novartis Investigative Site
Karlsruhe, 76185
Novartis Investigative Site
Kempten, 87435
Novartis Investigative Site
Kiel, 24105
Novartis Investigative Site
Koblenz, 56072
Novartis Investigative Site
Leer, 26789
Novartis Investigative Site
Leipzig, 04106
Novartis Investigative Site
Leipzig, 04229
Novartis Investigative Site
Lübeck, 23538
Novartis Investigative Site
Ludwigshafen, 67059
Novartis Investigative Site
Ludwigshafen, 67069
Novartis Investigative Site
Mainz, 55116
Novartis Investigative Site
Mainz, 55124
Novartis Investigative Site
Mainz, 55131
Novartis Investigative Site
Meiben, 01662
Novartis Investigative Site
Minden, 32427
Novartis Investigative Site
Moers, 47441
Novartis Investigative Site
München, 80335
Novartis Investigative Site
München, 80377
Novartis Investigative Site
München, 80637
Novartis Investigative Site
München, 81925
Novartis Investigative Site
München, 85356
Novartis Investigative Site
Münster, 48143
Novartis Investigative Site
Münster, 48145
Novartis Investigative Site
Mutterstadt, 67112
Novartis Investigative Site
Neu-Ulm, 89231
Novartis Investigative Site
Neubrandenburg, 17033
Novartis Investigative Site
Neubrandenburg, 17036
Novartis Investigative Site
Neustadt, 67433
Novartis Investigative Site
Neustadt A. D. Weinstraße, 67433
Novartis Investigative Site
Neutraubling, 93073
Novartis Investigative Site
Neuwied, 56564
Novartis Investigative Site
Nuremberg, 90403
Novartis Investigative Site
Obernkirchen, 31683
Novartis Investigative Site
Offenburg, 77654
Novartis Investigative Site
Oldenburg, 26121
Novartis Investigative Site
Oldenburg, 26123
Novartis Investigative Site
Osnabrück, 49076
Novartis Investigative Site
Paderborn, 33098
Novartis Investigative Site
Paderborn, 33100
Novartis Investigative Site
Peine, 31224
Novartis Investigative Site
Pfaffenhofen, 85276
Novartis Investigative Site
Pirna, 01796
Novartis Investigative Site
Plauen, 08523
Novartis Investigative Site
Polch, 56751
Novartis Investigative Site
Prien am Chiemsee, 83209
Novartis Investigative Site
Quakenbrück, 49610
Novartis Investigative Site
Raesfeld, 46348
Novartis Investigative Site
Ratingen, 40885
Novartis Investigative Site
Regensburg, 93 047
Novartis Investigative Site
Rhauderfehn, 26817
Novartis Investigative Site
Rheine, 48429
Novartis Investigative Site
Rostock, 18057
Novartis Investigative Site
Rüsselsheim am Main, 65428
Novartis Investigative Site
Saarbrücken, 66113
Novartis Investigative Site
Saarbrücken, 66119
Novartis Investigative Site
Saarburg, 54439
Novartis Investigative Site
Saarlouis, 66740
Novartis Investigative Site
Salzgitter, 38226
Novartis Investigative Site
Schweinfurt, 97421
Novartis Investigative Site
Siegen, 57072
Novartis Investigative Site
Sindelfingen, 71063
Novartis Investigative Site
Speyer, 67346
Novartis Investigative Site
Straubing, 94315
Novartis Investigative Site
Torgau, 04860
Novartis Investigative Site
Trier, 54290
Novartis Investigative Site
Troisdorf, 53844
Novartis Investigative Site
Tübingen, 72076
Novartis Investigative Site
Ulm, 89073
Novartis Investigative Site
Waldshut-Tiengen, 79761
Novartis Investigative Site
Wedel, 22880
Novartis Investigative Site
Westerstede, 26655
Novartis Investigative Site
Wismar, 23966
Novartis Investigative Site
Worms, 67547
Novartis Investigative Site
Würzburg, 97080
Switzerland10 sites
Novartis Investigative Site
Aarau, 5001
Novartis Investigative Site
Basel, 4051
Novartis Investigative Site
Basel, 4056
Novartis Investigative Site
Bern, Canton of Bern, 3011
Novartis Investigative Site
Fribourg, 1708
Novartis Investigative Site
Geneva, 1204
Novartis Investigative Site
Geneva, 1205
Novartis Investigative Site
Neuchâtel, Canton of Neuchâtel, 2000
Novartis Investigative Site
Wil, Canton of St. Gallen, 9500
Novartis Investigative Site
Zurich, 8091
Netherlands8 sites
Novartis Investigative Site
's-Hertogenbosch, 5223 GZ
Novartis Investigative Site
Bergen op Zoom, North Brabant, 4611 AN
Novartis Investigative Site
Deventer, 7416 SE
Novartis Investigative Site
Heerhugowaard, North Holland, 1703 DC
Novartis Investigative Site
Rotterdam, 3011 BH
Novartis Investigative Site
Rotterdam, 3079 DZ
Novartis Investigative Site
Terneuzen, 4535 PA
Novartis Investigative Site
Tilburg, NL-5022GC
About this study
Official title: 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.
Read the 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.
- Being tested
- Lucentis
- Keywords
- Lucentis, Ranibizumab, Neovascular (wet) age-related macular degeneration, nAMD, diabetic macular edema, retinal vein occlusions, choroidal neovascularizations
- Medical subject headings
- Macular Degeneration, Retinal Vein Occlusion, Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LucentisDrug
There is no treatment allocation. Patients administered Lucentis by prescription that have started before inclusion of the patient into the study will be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Lucentis | Patients administered Lucentis by prescription Receives: Drug: Lucentis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Up to month 24
Secondary outcomes (12)
Number of treatments
Number of treatments will be provided
Measured: Up to 24 months
Number of visits
Number of visits will be provided
Measured: Up to 24 months
Time interval between treatments
Time interval between treatments will be provided
Measured: Up to 24 months
Time interval between visits
Time interval between visits will be provided
Measured: Up to 24 months
Duration of treatment period
Duration of treatment period will be provided
Measured: Up to 24 months
Maximum period of treatment extension
Maximum period of treatment extension (where applicable)
Measured: Up to 24 months
Number of retreatments
Number of retreatments will be provided
Measured: Up to 24 months
Reasons for retreatment
Reasons for retreatment will be provided
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start1 Jun 2015
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular (Wet) Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847895
- Sponsor's protocol ID
- CRFB002ADE28
- Acronym
- PACIFIC
- Status last verified
- Apr 2021
- First submitted
- 26 Mar 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Treatment Patterns With Lucentis® (Ranibizumab) in Real-life Conditions in All Approved Indications
- ClinicalTrials.gov ID
- NCT04847895
- Acronym / sponsor ID
- PACIFIC / CRFB002ADE28
- Keywords
- Lucentis, Ranibizumab, Neovascular (wet) age-related macular degeneration, nAMD, diabetic macular edema, retinal vein occlusions, choroidal neovascularizations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,500 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lucentis | – | Drug: LucentisPatients administered Lucentis by prescription |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Male or female patients, ≥18 years of age, being treated with Lucentis® for any approved indication in the local Lucentis® SmPC
- Written informed consent
Key exclusion criteria (2 listed)
- As described in Lucentis® SmPC
- Participation in any other clinical study or NIS with Lucentis® as the investigational drug (such as OCEAN or LUMINOUS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LucentisThere is no treatment allocation. Patients administered Lucentis by prescription that have started before inclusion of the patient into the study will be enrolled. | Drug | Lucentis |
Primary outcome
mean change in visual acuity
Time frame: 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.
mean change in central retinal thickness
Time frame: Baseline, Up to month 24
As central retinal thickness data is optional, this analysis will be performed only if data allow.
12 secondary outcomes
Number of treatments
Time frame: Up to 24 months
Number of visits
Time frame: Up to 24 months
Time interval between treatments
Time frame: Up to 24 months
Time interval between visits
Time frame: Up to 24 months
Duration of treatment period
Time frame: Up to 24 months
Maximum period of treatment extension
Time frame: Up to 24 months
Number of retreatments
Time frame: Up to 24 months
Reasons for retreatment
Time frame: Up to 24 months
Monitoring and treatment regimen - Therapy schemes
Time frame: Up to 24 months
Reasons for choice of treatment regimen
Time frame: Up to 24 months
Monitoring and treatment patterns as a function of health insurances
Time frame: Up to 24 months
Number of treatments with Lucentis® vials and pre-filled syringe
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Individual participant dataSharing planned: No
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A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
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RecruitingPhase 1
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
175 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neovascular (Wet) Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 175 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 175 sites in Germany, Switzerland, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean change in visual acuity (time frame: Baseline, Up to month 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.