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Prospective Randomized Controlled Study of Intravitreal Injection of Bevacizumab for Proliferative Diabetic Retinopathy

11. juni 2014 opdateret af: Ayumu Manabe, Nihon University

Prospective Randomized Controlled Study of Intravitreal Injection of 0.16 mg Bevacizumab One Day Before Surgery for Proliferative Diabetic Retinopathy

We hypothesized that to reduce the adverse effects of intravitreal bevacizumab on ocular tissue and whole body, intravitreal injection of a low concentration of bevacizumab and conducting vitrectomy shortly after the injection is useful. In the present prospective, double-masked, randomized, controlled study, we aimed to verify the usefulness of intravitreal injection of 0.16 mg/0.05 ml bevacizumab one day before conducting vitrectomy for PDR.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Early postoperative hemorrhage in proliferative diabetic retinopathy (PDR) patients is a major complication. Intravitreal injection of anti-vascular endothelial growth factor (VEGF) has reported to reduce vitreous hemorrhage. Recently, numerous reports have shown the efficacy of reducing neovascularization activity before vitrectomy by preoperative intravitreal injection of anti-VEGF agents. When intravitreal bevacizumab (IVB) injection is used as an adjunct therapy, a shortterm effect is needed. Because it is reported some adverse events caused by bevacizumab injection. Hattori et al reported intravitreal injection of 0.16 mg/0.05 ml bevacizumab in PDR patients marked blockage of intravitreal VEGF concentrations in the pilot study. The purpose of this study is to evaluate low dose of intravitreal bevacizumab as a preoperative adjunct therapy reduce the postoperative vitreous hemorrhage. This study involves PDR patients who underwent vitrectomy between May 2012 and August 2013 at Surugadai Hospital of Nihon University. The risks to participants are accompanied by the intravitreal injection of bevacizumab (especially the possibility of endophthalmitis and thromboembolic events).

Between June 2012 and August 2013, one investigator (AM) randomized PDR patients with an indication for primary 25-gauge vitrectomy into a sham group and an IVB group. One day after injection, three surgeons except AM conducted the surgeries. Vitreous samples were collected at the start of surgery, and intraoperative and postoperative complications were evaluated.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

69

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Japan
      • Tokyo, Japan, 101-8309
        • Surugadai Nihon university hospital

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Clinical diagnosis of Proliferative Diabetic Retinopathy (PDR)
  • Indicated for vitrectomy

Exclusion Criteria:

  • History of intraocular surgery, intravitreal injection of drugs or sub-Tenon injection of steroids or retinal photocoagulation within 6 months

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Bevacizumab injection and vitrectomy
0.16 mg/0.05 ml bevacizumab intravitreal injection one day before vitrectomy.
Medicin: Bevacizumab
0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation)
Andre navne:
  • Avastin
Procedure: Vitrectomy
vitrectomy of 25 gauge system.
Sham-komparator: Sham injection and vitrectomy
Sham injection one day before vitrectomy.
Procedure: Vitrectomy
vitrectomy of 25 gauge system.
Enhed: Sham injection
Sham injection one day before vitrectomy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Reoperation
Tidsramme: 1 month
Vitreoretinal reoperation due to recurrent vitreous hemorrhage.
1 month

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Intra Operative Hemorrhage
Tidsramme: End of the surgery.
Calculate the number of coagulators for the intra operative hemorrhage.
End of the surgery.
Postoperative Vitreous Hemorrhage.
Tidsramme: 1 month
Postoperative vitreous hemorrhage that is permitted within 4 weeks after surgery.
1 month
Vascular Endothelial Growth Factor Concentration in Vitreous
Tidsramme: Start of surgery.
Vascular endothelial growth factor concentration in vitreous at the start of vitrectomy.
Start of surgery.
Endolaser Photocoagulation
Tidsramme: End of surgery.
Number of intraoperative endolaser photocoagulation.
End of surgery.
Iatrogenic Retinal Tears
Tidsramme: End of surgery.
The number of participants who had intraoperative iatrogenic retinal tears.
End of surgery.
Surgical Time
Tidsramme: End of surgery.
End of surgery.
Postoperative Best Corrected Visual Acuity
Tidsramme: 1 mouth after surgery.

Best corrected visual acuity was measured using the Landolt ring chart, and the result was converted to logMAR notation for analysis.

The minimum of the scale is 2.0 and the maximum of the scale is -0.3. The higher values represent a worse outcome.
1 mouth after surgery.
Best Corrected Visual Acuity Change
Tidsramme: 1 month

Best corrected visual acuity change was calculated by postoperative logMAR visual acuity minus preoperative logMAR visual acuity.

The higher values represent a worse outcome.
1 month
Postoperative Neovascular Glaucoma
Tidsramme: Within 1 month after the surgery.
The number of participants with progressive or persistent neovascular glaucoma after surgery.
Within 1 month after the surgery.
Elevated Intraocular Pressure
Tidsramme: Within 1 month after the surgery.
The number of participants with elevated intraocular pressure after surgery.
Within 1 month after the surgery.
Gas Tamponade
Tidsramme: End of surgery.
The number of participants with gas tamponade at the end of the surgery.
End of surgery.
Silicon Oil Tamponade
Tidsramme: End of surgery.
The number of participants with silicon oil tamponade at the end of the surgery.
End of surgery.

Samarbejdspartnere og efterforskere

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

Sponsor

Nihon University

Efterforskere

  • Studiestol: Ayumu Manabe

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. maj 2012

Primær færdiggørelse (Faktiske)

1. august 2013

Studieafslutning (Faktiske)

1. marts 2014

Datoer for studieregistrering

Først indsendt

13. maj 2013

Først indsendt, der opfyldte QC-kriterier

13. maj 2013

Først opslået (Skøn)

15. maj 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. juli 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juni 2014

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CCT-NAPN-23170

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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