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

NCT00892398 | Completed DMC

• 1 other identifier: CRFB002ACA04T
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

Trabeculectomy; Vascular Endothelial Growth Factor A; Wound Healing; Angiogenesis Inhibitors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Bleb morphology using Moorfields bleb grading system

  one year

Study Arms (2)

ranibizumab

EXPERIMENTAL

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

Drug: ranibizumab

standard care

ACTIVE COMPARATOR

Trabeculectomy with mitomycin C and standard post-operative care

Procedure: standard care

Interventions

ranibizumab 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.

ranibizumab

standard care PROCEDURE

standard post-operative care after trabeculectomy with mitomycin C

standard care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead
• Novartis: collaborator

Study Sites (1)

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T2M4, Canada

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Ranibizumab; Standard of Care

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Gisele Li, M.D.

  Maisonneuve-Rosemont Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 1, 2009
• First Posted: May 4, 2009
• Study Start: March 1, 2009
• Primary Completion: October 1, 2013
• Study Completion: March 1, 2014
• Last Updated: April 10, 2014

Record last verified: 2014-04

Locations

CA (1)