Long-Term Non-Interventional Study (NIS) To Investigate The Safety And Effectiveness Of MACUGEN In Patients With Neovascular Age-Related Macular Degeneration Under Conditions Of Routine Clinical Practice
6. november 2018 opdateret af: Pfizer
To define what procedures were used for the diagnosis and monitoring of the treatment age-related macular degeneration (AMD).
What is the effect of the Macugen, compliance with Macugen treatment, safety profile of Macugen, final physician assessment of treatment with Macugen.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
no sampling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
108
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Brno, Tjekkiet, 625 00
- Pfizer Investigational Site
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Brno, Tjekkiet, 62500
- Pfizer Investigational Site
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Olomouc, Tjekkiet, 775 20
- Pfizer Investigational Site
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Olomouc, Tjekkiet, 77520
- Pfizer Investigational Site
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Ostrava - Poruba, Tjekkiet, 70852
- Pfizer Investigational Site
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Plzen, Tjekkiet, 304 60
- Pfizer Investigational Site
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Praha 2, Tjekkiet, 128 08
- Pfizer Investigational Site
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Praha 2, Tjekkiet, 12808
- Pfizer Investigational Site
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Praha 6, Tjekkiet, 169 00
- Pfizer Investigational Site
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Praha 6, Tjekkiet, 169 02
- Pfizer Investigational Site
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Usti nad Labem, Tjekkiet, 40113
- Pfizer Investigational Site
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
outpatients
Beskrivelse
Inclusion Criteria:
- age over 18 years old
- patients with neovascular age-related macular degeneration
- enrollment to study is fully on physician decision in compliance with current SPC
Exclusion Criteria:
- Patient who did not meet indication according to SPC Macugen.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
AMD
|
Outpatients with age-related macular degeneration (AMD)
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Visual Acuity (VA) at Final Visit
Tidsramme: Baseline, Final Visit (Week 104 or early termination [ET])
|
Visual acuity (VA) measured as viewing distance (distance for participant/distance for normal vision).
Viewing distance considered as fraction to calculate decimal VA.
Decimal VA data presented as Logarithm of Minimum Angle of Resolution (logMAR), logMAR= -log10 (decimal VA).
It measures VA loss; positive values indicated vision loss, while negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts (85 or 100 letters, 85 letter equivalents to decimal VA of 1.0).
Results were based on study eye for which medication was given.
|
Baseline, Final Visit (Week 104 or early termination [ET])
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Visual Acuity (VA) at Each Visit
Tidsramme: Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102
|
VA measured as viewing distance (distance for participant/distance for normal vision).
Viewing distance considered as fraction to calculate decimal VA.
Decimal VA data presented as logMAR, logMAR= -log10 (decimal VA).
It measures VA loss; positive values indicated vision loss, while negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts (85 or 100 letters, 85 letter equivalents to decimal VA of 1.0).
Results were based on study eye for which medication was given.
|
Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Tidsramme: Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102
|
VA measured as viewing distance (distance for participant/distance for normal vision).
Viewing distance considered as fraction to calculate decimal VA. logMAR= -log10 (decimal VA).
It measures VA loss; positive values indicated vision loss,negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts(85 or 100 letters, 85 letter equivalents to decimal VA of 1.0).
Results based on study eye for which medication was given.
Number of participants with VA improved, unchanged or worsened as compared to previous examination reported.
|
Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102
|
|
Physician's Assessment of Efficacy
Tidsramme: Week 104 or End of study (EOS)
|
Efficacy was based on the study eye for which pegaptanib treatment was given.
Number of participants with each grade of efficacy of treatment, as assessed by the physician was reported on the 5 point categorical scale: excellent, very good, good, fair, poor.
|
Week 104 or End of study (EOS)
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Tidsramme: Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102
|
Procedures used for diagnosis of AMD and monitoring of the course of treatment included fluorescein angiography (FA), optical coherent tomography (OCT), or other (Ot) procedure apart from FA and OCT.
OCT, FA, and other are not mutually exclusive, hence same participant may be included in more than 1 procedure for AMD diagnosis and monitoring at a particular time point.
|
Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102
|
|
Number of Participants Who Discontinued Treatment Due to Adverse Events (AEs)
Tidsramme: Baseline up to Week 104 (EOS)
|
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
|
Baseline up to Week 104 (EOS)
|
|
Duration of Treatment
Tidsramme: Baseline up to Week 104 (EOS)
|
Duration of treatment (in weeks) was calculated as: (date of the last injection of study medication minus date of the first injection of study medication plus 1) divided by 7.
|
Baseline up to Week 104 (EOS)
|
|
Mean Number of Doses of Study Medication Received
Tidsramme: Baseline up to Week 104 (EOS)
|
Baseline up to Week 104 (EOS)
|
|
|
Physician's Assessment of Tolerability
Tidsramme: Baseline up to Week 104 (EOS)
|
Number of participants with each grade of tolerability of treatment as assessed by physician was evaluated on the five point categorical scale: excellent, very good, good, fair, poor.
|
Baseline up to Week 104 (EOS)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2010
Primær færdiggørelse (Faktiske)
1. juni 2012
Studieafslutning (Faktiske)
1. juni 2012
Datoer for studieregistrering
Først indsendt
6. november 2008
Først indsendt, der opfyldte QC-kriterier
6. november 2008
Først opslået (Skøn)
7. november 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. december 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. november 2018
Sidst verificeret
1. november 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- A5751032
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .