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

NCT ID: NCT00892398

Last Updated: 2014-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2014-03-31

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.

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ranibizumab

Trabeculectomy with mitomycin C associated with 2 subconjunctival injections of ranibizumab: 1 intraoperatively and 1 at 2 weeks post-operatively

Group Type: EXPERIMENTAL

ranibizumab

Intervention Type: DRUG

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.

standard care

Trabeculectomy with mitomycin C and standard post-operative care

Group Type: ACTIVE_COMPARATOR

standard care

Intervention Type: PROCEDURE

standard post-operative care after trabeculectomy with mitomycin C

Interventions

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.

Intervention Type: DRUG

standard care

standard post-operative care after trabeculectomy with mitomycin C

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gisele Li

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gisele Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Maisonneuve-Rosemont Hospital

Locations

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

CRFB002ACA04T

Identifier Type: -

Identifier Source: org_study_id