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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
  Purpose

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 Intervention
Glaucoma
Drug: ranibizumab
Procedure: standard care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Trabeculectomy With Mitomycin C Associated With Sub-conjunctival Injection of Ranibizumab

Resource links provided by NLM:


Further study details as provided by Maisonneuve-Rosemont Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Bleb morphology using Moorfields bleb grading system [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 242
Study Start Date: March 2009
Study Completion Date: March 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892398

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

No publications provided

Responsible Party: Gisele Li, Assistant Professor, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier: NCT00892398     History of Changes
Other Study ID Numbers: CRFB002ACA04T
Study First Received: May 1, 2009
Last Updated: April 8, 2014
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Mitomycin
Mitomycins
Alkylating Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014