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

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Gisele Li, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier:
NCT00892398
First received: May 1, 2009
Last updated: April 8, 2014
Last verified: April 2014

May 1, 2009
April 8, 2014
March 2009
October 2013   (final data collection date for primary outcome measure)
Failure rates of the surgery as defined by intraocular pressure reductions [ Time Frame: one year ] [ Designated as safety issue: No ]
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.
Failure rates of the surgery as defined by intraocular pressure reductions [ Time Frame: one year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00892398 on ClinicalTrials.gov Archive Site
Bleb morphology using Moorfields bleb grading system [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Trabeculectomy With Mitomycin C Associated With Sub-conjunctival Injection of Ranibizumab
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Glaucoma
  • Drug: ranibizumab
    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.
  • Procedure: standard care
    standard post-operative care after trabeculectomy with mitomycin C
  • Experimental: ranibizumab
    Trabeculectomy with mitomycin C associated with 2 subconjunctival injections of ranibizumab: 1 intraoperatively and 1 at 2 weeks post-operatively
    Intervention: Drug: ranibizumab
  • Active Comparator: standard care
    Trabeculectomy with mitomycin C and standard post-operative care
    Intervention: Procedure: standard care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
242
March 2014
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00892398
CRFB002ACA04T
Yes
Gisele Li, Maisonneuve-Rosemont Hospital
Maisonneuve-Rosemont Hospital
Novartis
Principal Investigator: Gisele Li, M.D. Maisonneuve-Rosemont Hospital
Maisonneuve-Rosemont Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP