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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: ranibizumab
* Procedure: standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ranibizumab<br>Trabeculectomy with mitomycin C associated with 2 subconjunctival injections of ranibizumab: 1 intraoperatively and 1 at 2 weeks post-operatively | Drug: ranibizumab<br>* 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.<br>|
| Active Comparator: standard care<br>Trabeculectomy with mitomycin C and standard post-operative care | Procedure: standard care<br>* standard post-operative care after trabeculectomy with mitomycin C<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure rates of the surgery as defined by intraocular pressure reductions | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleb morphology using Moorfields bleb grading system |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trabeculectomy, Vascular Endothelial Growth Factor A, Wound Healing, Angiogenesis Inhibitors