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Intravitreal Ranibizumab and TA Combination Therapy vs. Ranibizumab Monotherapy in Polypoidal Choroidal Vasculopathy (RANTA)

29. november 2018 opdateret af: Aier School of Ophthalmology, Central South University

Multicenter Randomized Controlled Study of Intravitreal Ranibizumab and Triamcinolone Acetonide Combination Therapy Versus Ranibizumab Monotherapy in Patients With Polypoidal Choroidal Vasculopathy

The purpose of this study is to evaluate the effects and safety of ranibizumab therapy combined with TA versus ranibizumab monotherapy in patients with polypoidal choroidal vasculopathy (PCV). Furthermore, the pharmacogenetics effect of inflammatory related genes polymorphism in response to the treatments. To further confirm the role of inflammatory factors in the pathogenesis and advance of PCV.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Polypoidal choroidal vasculopathy (PCV), a vascular disease of the choroid, appears to be the predominant subtype of exudative or "wet" AMD in Asian populations, in contrast to choroidal neovascularization secondary to AMD (CNV-AMD) in Western populations. There are distinct differences in pathophysiological, clinical and epidemiological factors between the two subtypes, although they also share some common risk factors. In contrast to CNV-AMD, PCV does not seem to respond as well to anti-VEGF treatment. The optimal treatment option for PCV remains elusive, with most studies showing good short-term visual outcome but poorer longer-term outcome with current treatment strategies. Therefore, understanding the pathogenesis of PCV, while developing novel and effective treatments strategies to prevent PCV-related vision loss is significant unmet needs.

The purpose of this study is to assess the effects and safety of ranibizumab therapy combined with TA versus ranibizumab monotherapy in patients with PCV. Second, the pharmacogenetics effect of inflammatory related genes and polymorphism in response to the treatments of PCV will be explored. To further confirm the role of inflammatory factors in the pathogenesis and advance of PCV, it is important to determine the levels of inflammatory factors in the anterior chamber aqueous humor from PCV patients, comparing with the aqueous humor acquired from the age-matched age-related cataract patients undergoing phacoemulsification.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

120

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina
        • Beijing Aier Intech Eye Hospital
    • Guangdong
      • Guanzhou, Guangdong, Kina
        • Guangzhou Aier Eye Hospital
      • Shenzhen, Guangdong, Kina, 510000
        • Shenzhen Aier Eye Hospital
      • Shenzhen, Guangdong, Kina, 528000
        • Shenzhen Eye Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, Kina
        • Harbin Aier Eye Hospital
    • Hubei
      • Wuhan, Hubei, Kina
        • Wuhan General Hospital of Pla
    • Zhejiang
      • Wenzhou, Zhejiang, Kina, 325027
        • The Eye Hospital of Wenzhou Medical University

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 til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • bestcorrected visual acuity (BCVA) letter score of 73 to 24 using Early Treatment of Diabetic Retinopathy Study charts at a starting distance of 4 m (20/40 to 20/320 Snellen equivalent);
  • a greatest lineardimensionof the lesion of <5400 um( 9 Macular Photocoagulation Study disk areas), assessed by ICGA;
  • Cross-reading by different center to confirmed diagnosis of PCV, that is, presence of early subretinal focal ICGA hyperfluorescence (appearing within the first 6 minutes after injection of indocyanine green) and in addition, at least one of the following angiographic or clinical criteria: (i) association with a BVN, (ii) presence of pulsatile polyp, (iii) nodular appearance when viewed stereoscopically, (iv) presence of hypofluorescent halo (in first 6 minutes),7 (v) orange subretinal nodules in stereoscopic color fundus photograph (polyp corresponding to ICGA lesions), or (vi) association with massive submacular hemorrhage (defined as size of hemorrhage of at least 4 disk areas).

Exclusion Criteria:

  • received treatment previously with verteporfin PDT, focal laser photocoagulation, transpupillary thermotherapy, pneumatic displacement of subretinal blood, or any investigational treatment;
  • a history of angioid streaks, presumed ocular histoplasmosis syndrome, or pathologic myopia;
  • experienced RPE tear, retinal detachment, macular hole, or uncontrolled glaucoma;
  • undergone intraocular surgery (except uncomplicated cataract extraction with intraocular lens implantation within 60 days before the screening visit)

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Ranibizumab + Triamcinolone Acetonide
intravitreal injection: Ranibizumab 0.5mg + Triamcinolone Acetonide 2mg
Medicin: Triamcinolone Acetonide
Intravitreal inject 0.5mg of Ranibizumab and 2mg of Triamcinolone Acetonide.
Andre navne:
  • RANTA
Medicin: Ranibizumab
Intravitreal inject 0.5mg of Ranibizumab.
Andre navne:
  • RAN
Aktiv komparator: Ranibizumab
intravitreal injection: Ranibizumab 0.5mg
Medicin: Ranibizumab
Intravitreal inject 0.5mg of Ranibizumab.
Andre navne:
  • RAN

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change of mean BCVA
Tidsramme: 12 months
Change of Central BCVA (Measured with EDTRS Chart,numbers of letters) (primary: baseline and 6 months, secondary: baseline to 12 months)
12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change of Central Rerina Thickness
Tidsramme: 12 months
Change of Central Rerina Thickness (um) (primary: between baseline and 6 months, secondary: between baseline to 12 months)
12 months
regression of Branch vacular network(BVN)
Tidsramme: 12 months
Size of Branch vascular network (um)
12 months
Polyps regression
Tidsramme: 12 months
Size of polyps (um)(primary: between baseline and 6 months, secondary: between baseline to 12 months)
12 months
Number of re-treatments
Tidsramme: 12 month
re-treatments numbers
12 month

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Aier School of Ophthalmology, Central South University

Efterforskere

  • Studiestol: Shibo Tang, Aier School of Ophthalmology, Central South University

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)

1. januar 2017

Primær færdiggørelse (Forventet)

1. december 2018

Studieafslutning (Forventet)

1. december 2019

Datoer for studieregistrering

Først indsendt

17. april 2016

Først indsendt, der opfyldte QC-kriterier

16. juni 2016

Først opslået (Skøn)

21. juni 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. november 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. november 2018

Sidst verificeret

1. november 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB2016006

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

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