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

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ClinicalTrials.gov Identifier: NCT00892398
Recruitment Status : Completed
First Posted : May 4, 2009
Last Update Posted : April 10, 2014
Information provided by (Responsible Party):
Gisele Li, Maisonneuve-Rosemont Hospital

Brief Summary:

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.

Condition or disease Intervention/treatment
Glaucoma Drug: ranibizumab Procedure: standard care

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Trabeculectomy With Mitomycin C Associated With Sub-conjunctival Injection of Ranibizumab
Study Start Date : March 2009
Primary Completion Date : October 2013
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: ranibizumab
Trabeculectomy with mitomycin C associated with 2 subconjunctival injections of ranibizumab: 1 intraoperatively and 1 at 2 weeks post-operatively
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.
Active Comparator: standard care
Trabeculectomy with mitomycin C and standard post-operative care
Procedure: standard care
standard post-operative care after trabeculectomy with mitomycin C

Primary Outcome Measures :
  1. Failure rates of the surgery as defined by intraocular pressure reductions [ Time Frame: 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.

Secondary Outcome Measures :
  1. Bleb morphology using Moorfields bleb grading system [ Time Frame: one year ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00892398

Canada, Quebec
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T2M4
Sponsors and Collaborators
Maisonneuve-Rosemont Hospital
Principal Investigator: Gisele Li, M.D. Maisonneuve-Rosemont Hospital

Responsible Party: Gisele Li, Assistant Professor, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier: NCT00892398     History of Changes
Other Study ID Numbers: CRFB002ACA04T
First Posted: May 4, 2009    Key Record Dates
Last Update Posted: April 10, 2014
Last Verified: April 2014

Keywords provided by Gisele Li, Maisonneuve-Rosemont Hospital:
Vascular Endothelial Growth Factor A
Wound Healing
Angiogenesis Inhibitors

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antibiotics, Antineoplastic
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors