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Trabeculectomy With Mitomycin C Associated With Sub-conjunctival Injection of Ranibizumab

8. april 2014 opdateret af: Gisele Li, Maisonneuve-Rosemont Hospital

Trabeculectomy with mitomycin C remains the standard surgery for glaucoma. This surgery involves creating a door in the eye wall in order to improve fluid outflow and decrease intraocular pressure. However, success rates range from 70% to 90% depending on the criteria used and tend to decrease with time. The failure of the surgery is associated with inflammation, new blood vessel formation and scarring which can cause closure of the door. Molecules which inhibit new blood vessel formation such as inhibitors of vascular endothelial growth factor have been used successfully to decrease scarring in animal eyes where little doors were created and significantly improve survival. Furthermore, they have shown promise when used during trabeculectomy. Ranibizumab, a vascular endothelial growth factor, has also been used safely in intraocular surgery to treat other diseases which involve new blood vessel formation such as macular degeneration and diabetes.

The investigators hypothesize that ranibizumab may decrease the failure rate of trabeculectomy with mitomycin C by decreasing scarring.

The aim of the study is to evaluate the difference in failure rates and bleb morphology at one year post-operatively in eyes having undergone sub-conjunctival injections of ranibizumab in addition to primary trabeculectomy with mitomycin C compared to eyes having undergone trabeculectomy with mitomycin C alone.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Prospective, randomized, unblinded clinical trial. Two groups of patients with glaucoma undergoing primary trabeculectomy or phaco-trabeculectomy with MMC between March 2009 and September 2012. The ranibizumab group (RAN) received 2 subconjunctival injections of 0.5 mg of ranibizumab (intraoperatively and on day 14) and he control group did not receive ranibizumab.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

242

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • Quebec
      • Montreal, Quebec, Canada, H1T2M4
        • Maisonneuve-Rosemont 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

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • to have uncontrolled glaucoma
  • to have accepted to undergo a primary trabeculectomy with mitomycin C
  • to have one of the following types of glaucoma:

    • Normal tension Glaucoma
    • Chronic Open-Angle Glaucoma
    • Chronic Angle-Closure Glaucoma
    • Mixed mechanism glaucoma
    • Steroid-induced Glaucoma
    • Neovascular Glaucoma

Exclusion Criteria:

  • to be less than 18 years old
  • to be unable to observe the study protocol
  • to present some risk factors for thromboembolic events and cerebrovascular accidents : hypertension, dyslipidemia, coronary artery diseases
  • a history of thromboembolic events and cerebrovascular accidents
  • congenital glaucoma
  • uveitic glaucoma
  • to be pregnant
  • to be breastfeeding
  • surgical complications prior to injection of the study drug such as vitreous in the anterior chamber or the presence of suprachoroidal hemorrhages
  • to have undergone a previous conjunctival surgery
  • to be hypersensitive to the drug, to one of the components of the drug or to one of the components of the packaging
  • to present an active or suspected intraocular or periocular inflammation
  • to have a kidney failure
  • to have a liver failure

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
Trabeculectomy with mitomycin C associated with 2 subconjunctival injections of ranibizumab: 1 intraoperatively and 1 at 2 weeks post-operatively
Two ranibizumab subconjunctival injections (0.5 mg ∕ 0.05 mL). The first injection at the end of the surgery (intraoperative) and the second two weeks post-operatively.
Aktiv komparator: standard care
Trabeculectomy with mitomycin C and standard post-operative care
standard post-operative care after trabeculectomy with mitomycin C

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Failure rates of the surgery as defined by intraocular pressure reductions
Tidsramme: one year
Complete success: post-operative IOP between 5-18 mm Hg and at least a 20% reduction in IOP from baseline without the use of glaucoma medications. Qualified success: similar definition with the use of glaucoma medications.
one year

Sekundære resultatmål

Resultatmål
Tidsramme
Bleb morphology using Moorfields bleb grading system
Tidsramme: one year
one year

Samarbejdspartnere og efterforskere

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

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Gisele Li, M.D., Maisonneuve-Rosemont Hospital

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. marts 2009

Primær færdiggørelse (Faktiske)

1. oktober 2013

Studieafslutning (Faktiske)

1. marts 2014

Datoer for studieregistrering

Først indsendt

1. maj 2009

Først indsendt, der opfyldte QC-kriterier

1. maj 2009

Først opslået (Skøn)

4. maj 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. april 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. april 2014

Sidst verificeret

1. april 2014

Mere information

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 .

Kliniske forsøg med ranibizumab

3
Abonner