Clinical trial NCT00892398: Trabeculectomy With Mitomycin C Associated With Sub-conjunctival Injection of Ranibizumab
Official title: Trabeculectomy With Mitomycin C Associated With Sub-conjunctival Injection of Ranibizumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: Trabeculectomy
Vascular Endothelial Growth Factor A
Wound Healing
Angiogenesis Inhibitors
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2009-05-04
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Failure rates of the surgery as defined by intraocular pressure reductions
timeFrame: one year
Secondary outcomes:
measure: Bleb morphology using Moorfields bleb grading system
timeFrame: one year
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Maisonneuve-Rosemont Hospital
state: Quebec
Study officials:
affiliation: Maisonneuve-Rosemont Hospital
name: Gisele Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References: