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

11. juni 2014 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

69

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Bevacizumab injection and vitrectomy
0.16 mg/0.05 ml bevacizumab intravitreal injection one day before vitrectomy.
Legemiddel: Bevacizumab
0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation)
Andre navn:
  • Avastin
Fremgangsmåte: Vitrectomy
vitrectomy of 25 gauge system.
Sham-komparator: Sham injection and vitrectomy
Sham injection one day before vitrectomy.
Fremgangsmåte: Vitrectomy
vitrectomy of 25 gauge system.
Enhet: Sham injection
Sham injection one day before vitrectomy

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Nihon University

Etterforskere

  • Studiestol: Ayumu Manabe

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2012

Primær fullføring (Faktiske)

1. august 2013

Studiet fullført (Faktiske)

1. mars 2014

Datoer for studieregistrering

Først innsendt

13. mai 2013

Først innsendt som oppfylte QC-kriteriene

13. mai 2013

Først lagt ut (Anslag)

15. mai 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

14. juli 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. juni 2014

Sist bekreftet

1. juni 2014

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CCT-NAPN-23170

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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