Status:
COMPLETED
Trabeculectomy With Mitomycin C Associated With Sub-conjunctival Injection of Ranibizumab
Lead Sponsor:
Maisonneuve-Rosemont Hospital
Collaborating Sponsors:
Novartis
Conditions:
Glaucoma
Eligibility:
All Genders
18-75 years
Phase:
NA
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. Ho...
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 ra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT00892398
Start Date
March 1 2009
End Date
March 1 2014
Last Update
April 10 2014
Active Locations (1)
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1
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T2M4