- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00892398
Trabeculectomy With Mitomycin C Associated With Sub-conjunctival Injection of Ranibizumab
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
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Quebec
-
Montreal, Quebec, Canada, H1T2M4
- Maisonneuve-Rosemont Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
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
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Gisele Li, M.D., Maisonneuve-Rosemont Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CRFB002ACA04T
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
-
University of Campania "Luigi Vanvitelli"Afsluttet
-
University of Illinois at ChicagoGenentech, Inc.Trukket tilbageGrøn stær | Neovaskulært glaukom | Nyopstået glaukom | Nyopstået neovaskulært glaukom
-
Hawaii Pacific HealthGenentech, Inc.AfsluttetPolypoid choroidal vaskulopati | PCVForenede Stater
-
Lupin Ltd.RekrutteringNeovaskulær aldersrelateret makuladegenerationIndien
-
New England Retina AssociatesGenentech, Inc.AfsluttetChoroidalt melanomForenede Stater
-
Samsung Bioepis Co., Ltd.AfsluttetAldersrelateret makuladegenerationKorea, Republikken, Forenede Stater, Indien, Tyskland, Ungarn, Det Forenede Kongerige, Tjekkiet, Polen, Den Russiske Føderation
-
Especialistas en Retina Medica y Quirurgica Grupo...Centro de Retina Medica y Quirurgica S.C.AfsluttetDiabetisk makulært ødemArgentina, Mexico
-
Instituto de Olhos de GoianiaAfsluttet
-
Vista KlinikAfsluttetAldersrelateret makuladegeneration | Choroidal neovaskulariseringSchweiz
-
Pusan National University HospitalNovartisAfsluttetEksudativ aldersrelateret makuladegenerationKorea, Republikken