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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00892398
• Other study ID #: CRFB002ACA04T
• Status: Completed
• Phase: N/A
• First received: May 1, 2009
• Last updated: April 8, 2014
• Start date: March 2009
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Maisonneuve-Rosemont Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: March 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

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.

Procedure:
• standard care
standard post-operative care after trabeculectomy with mitomycin C

Locations

Country	Name	City	State
Canada	Maisonneuve-Rosemont Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital	Novartis

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Bleb morphology using Moorfields bleb grading system		one year	No