ProspectiveTrial of Proton Beam Combined With Anti-VEGF Therapy for Exudative Age-related Macular Degeneration (AMD) (PBAMD2)
19. juni 2018 opdateret af: University of California, Davis
Phase I/II Prospective, Randomized, Double-blinded Study of Intravitreal Anti-VEGF Therapy Combined With Proton Beam Radiation Versus Sham Irradiation in Treating Exudative Age-related Macular Degeneration
The purpose of this study is to test the hypothesis that proton beam irradiation combined with intravitreal anti-VEGF therapy is safe and potentially more effective than intravitreal anti-VEGF therapy alone in eyes with exudative age-related macular degeneration.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Radiation combined with anti-VEGF therapy has been shown to be synergistic in treating cancer and result in sustained tumor regression.
On-going clinical trials have shown potential synergism between intravitreal anti-VEGF therapy and epiretinal brachytherapy administered during vitrectomy surgery in treating eyes with exudative age-related macular degeneration (eAMD).
In this study, we test the hypothesis that radiation to the macula administered noninvasively via proton beam is well-tolerated in eyes with eAMD when combined with intravitreal anti-VEGF therapy and that this combination therapy may act synergistically to result in sustained treatment effect in eyes with eAMD.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
34
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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Sacramento, California, Forenede Stater, 95817
- University of California Davis Eye Center
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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
50 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
Subjects will be eligible if the following criteria are met:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 50 years
- Patient related considerations
- Able to maintain follow-up for at least 24 months.
- Women must be postmenopausal without a period for at least one year.
- Diagnosed with Age-related Macular Degeneration (ARMD) with active subfoveal choroidal neovascular membrane (CNVM), newly diagnosed or treated with first dose of anti-VEGF therapy within 6 weeks of enrollment
- Visual acuity 20/40 to 20/400
- Lesion size < 12 Disc Area
- Submacular hemorrhage less than 75% of total lesion and not involving foveal center
- Submacular fibrosis less than 25% of total lesion
- Candidate for intravitreal anti-VEGF therapy
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from this study:
- Prior enrollment in the study
- Pregnancy (positive pregnancy test) or lactation
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial
- Previous treatment with Photodynamic Therapy (PDT) or thermal laser in study eye
- Anti-VEGF therapy within 6 weeks
- Intravitreal or subtenon's Kenalog within 6 months
- Intraocular surgery within 3 months or expected in the next 6 months
- Current or planned participation in other experimental treatments for wet AMD
- Other concurrent retinopathy or optic neuropathy
- Other causes of CNVM, i.e. myopic degeneration or ocular histoplasmosis (POHS)
- Significant media opacity precluding adequate view of the fundus for exam, photography or OCT
- History of radiation therapy to the head or study eye
- Diabetes mellitus or hemoglobin A1c > 6
- Head tremor or h/o claustrophobia precluding positioning for proton irradiation
- Inability to maintain steady fixation with either eye
- History of Malignancy treated within 5 years
- Allergy to Fluorescein dye
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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 24GyE + anti-VEGF
|
24GyE proton beam will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy
Andre navne:
|
|
Eksperimentel: 16GyE + anti-VEGF
|
16GyE of Proton Beam Irradiation will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy
Andre navne:
|
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Sham-komparator: Sham Irradiation + anti-VEGF
|
2 Sessions of Sham Proton Beam Irradiation 24 hrs apart administered 2 to 6 weeks after intravitreal anti-VEGF therapy
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percent of Eyes With Severe Ocular Adverse
Tidsramme: Month 24
|
vision loss of 3 or more lines associated with radiation retinopathy or papillopathy
|
Month 24
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Anti-VEGF Injections Administered
Tidsramme: Month 24
|
efficacy measure
|
Month 24
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Susanna S Park, MD PhD, University of California, Davis
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. september 2010
Primær færdiggørelse (Faktiske)
31. januar 2017
Studieafslutning (Faktiske)
31. januar 2017
Datoer for studieregistrering
Først indsendt
29. september 2010
Først indsendt, der opfyldte QC-kriterier
30. september 2010
Først opslået (Skøn)
1. oktober 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. juli 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. juni 2018
Sidst verificeret
1. maj 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 223071
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