Langsigtet effektivitet og sikkerhed af intravitreale injektioner med Bevacizumab hos patienter med neovaskularisering eller makulært ødem (2013-005056-15)
Although the safety and efficacy of bevacizumab has been established in several phase 3 trials, there is only little documented about the long-term safety and efficacy in the 'real-world practice' in large populations from different regions.
Therefore the investigators evaluate the long-term safety and efficacy of intravitreal treatment with bevacizumab by registration of best corrected visual acuity, side-effects and central retinal thickness as measured with the ocular coherence tomography if available. This will allow the investigators to compare the results of their centre with the results of several phase 3 trials from the literature and will guide improvements in their treatment protocols.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
-
Ghent, Belgien, 9000
- Ghent University Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age ≥ 18 years of either gender
- Written informed consent must be obtained before any intravitreal injection of bevacizumab is performed
- Visual impairment predominantly due to abnormal new vessel ingrowth and/or macular edema. The presence of fluid (intraretinal, subretinal or sub-RPE) detected clinically or on the ocular coherence tomography.
If both eyes are eligible for the study, both eyes can be included in the study.
Exclusion Criteria:
- Women who are pregnant or breastfeeding (pregnancy defined as the state of a female after conception until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test (> 5mIU/mL)
- Women of child bearing potential must be practicing effective contraception implemented during the trial and for at least 28 days following the last dose of study medication
- Tromboembolic event (CVA or transient ischemic attack, AMI) less than 3 months prior to the intravitreal injection of bevacizumab
- History of hypersensitivity for bevacizumab.
Studieplan
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 |
|---|---|
|
Andet: åben etiket
|
Bevacizumab 1.25mg/0.05 mL will be injected intravitreally using one 30-gauge x 1/2-inch injection needle vials are for single eye use only. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Best Corrected Visual Acuity
Tidsramme: every visit, up to ten years
|
will be performed with a 1, 3 or 6 month interval (or more frequent) as long as there are signs of disease activity |
every visit, up to ten years
|
|
Slit lamp examination
Tidsramme: every visit, up to ten years
|
will be performed with a 1, 3 or 6 month interval (or more frequent) as long as there are signs of disease activity |
every visit, up to ten years
|
|
Dilated Fundoscopy
Tidsramme: every visit, up to ten years
|
will be performed with a 1, 3 or 6 month interval (or more frequent) as long as there are signs of disease activity |
every visit, up to ten years
|
|
Central Retinal Thickness
Tidsramme: annually, up to ten years
|
central retinal thickness as measured with the ocular coherence tomography |
annually, up to ten years
|
|
Fluorescein Angiography and Ocular Coherence Tomography
Tidsramme: annually, up to ten years
|
fluorescein angiography and ocular coherence tomography. The necessity of these investigations is determined by the degree of activity and as deemed necessary by the investigator. |
annually, up to ten years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
bivirkninger
Tidsramme: årligt, op til ti år
|
årligt, op til ti år
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Øjensygdomme
- Nethindesygdomme
- Nethindedegeneration
- Metaplasi
- Makuladegeneration
- Neovaskularisering, patologisk
- Patologiske tilstande, tegn og symptomer
- Makulaødem
- Retinal neovaskularisering
- Aminosyrer, peptider og proteiner
- Proteiner
- Antistoffer, monoklonal, humaniseret
- Antistoffer, monoklonal
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serum globuliner
- Globuliner
- Bevacizumab
Andre undersøgelses-id-numre
- BC-00584
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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