- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01903720
A Safety and Efficacy Study of OZURDEX® in Macular Edema Associated With Branch Retinal Vein Occlusion (COBALT)
9. april 2019 opdateret af: Allergan
This study will evaluate the safety and efficacy of OZURDEX® (700 µg dexamethasone implant) in patients with macular edema associated with branch retinal vein occlusion.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
71
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Seoul, Korea, Republikken
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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
Beskrivelse
Inclusion Criteria:
- Diagnosis of macular edema
- Best corrected visual acuity of approximately 20/400 to 20/40 in the study eye
Exclusion Criteria:
- Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month
- Intraocular surgery, including cataract surgery, and/or laser surgery of any type within 3 months
- Any active ocular infection in either eye
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: OZURDEX®
OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
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OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 6
Tidsramme: Baseline, Month 6
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BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best).
A positive number change in the number of letters read correctly means that the vision improved and a negative number change in the number of letters read correctly means that the vision has worsened.
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Baseline, Month 6
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change From Baseline in Central Retinal Thickness (CRT) at Month 6
Tidsramme: Baseline, Month 6
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CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina.
A negative change from Baseline indicates an improvement.
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Baseline, Month 6
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Change From Baseline in BCVA at Month 12
Tidsramme: Baseline, Month 12
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BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best).
A positive number change in the number of letters read correctly means that the vision improved and a negative number change in the number of letters read correctly means that the vision has worsened.
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Baseline, Month 12
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Change From Baseline in CRT at Month 12
Tidsramme: Baseline, Month 12
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CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina.
A negative change from Baseline indicates an improvement.
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Baseline, Month 12
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Change From Baseline in BCVA at Each Visit
Tidsramme: Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
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BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best).
A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.
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Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
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Change From Baseline in CRT at Each Visit
Tidsramme: Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
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CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina.
A negative change from Baseline indicates an improvement.
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Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
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Percentage of Participants With a Change From Baseline of 15 or More Letters in BCVA
Tidsramme: Baseline, Months 6 and 12
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BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best).
An increase in the number of letters read correctly means that the vision improved and a decrease in the number of letters read correctly means that the vision has worsened.
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Baseline, Months 6 and 12
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Percentage of Participants Receiving a Second Injection
Tidsramme: 12 Months
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12 Months
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Percentage of Participants Receiving a Third Injection
Tidsramme: 12 Months
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12 Months
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Time to Second Injection
Tidsramme: 12 Months
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Time in weeks from the first injection to the second injection.
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12 Months
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Time to Third Injection
Tidsramme: 12 Months
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Time in weeks from the second injection to the third injection.
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12 Months
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Percentage of Participants Who Received Laser Treatments
Tidsramme: 12 Months
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Participants underwent laser photocoagulation therapy for all areas of foveal leakage and non-perfusion, as well as areas of extensive retinal hyperplasia if applicable for rescue therapy.
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12 Months
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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 (Faktiske)
16. juli 2013
Primær færdiggørelse (Faktiske)
24. september 2014
Studieafslutning (Faktiske)
30. marts 2015
Datoer for studieregistrering
Først indsendt
16. juli 2013
Først indsendt, der opfyldte QC-kriterier
18. juli 2013
Først opslået (Skøn)
19. juli 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. april 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. april 2019
Sidst verificeret
1. april 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hjerte-kar-sygdomme
- Karsygdomme
- Øjensygdomme
- Nethindedegeneration
- Nethindesygdomme
- Embolisme og trombose
- Venøs trombose
- Trombose
- Makuladegeneration
- Makulaødem
- Retinal veneokklusion
- Ødem
- Lægemidlers fysiologiske virkninger
- Autonome agenter
- Agenter fra det perifere nervesystem
- Anti-inflammatoriske midler
- Antineoplastiske midler
- Antiemetika
- Gastrointestinale midler
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Dexamethason
Andre undersøgelses-id-numre
- APMA-OZU-01-01
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 .
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