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NCT Number: NCT00892398

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

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T2M4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard care

Procedure

standard post-operative care after trabeculectomy with mitomycin C

Primary outcomes

  1. Failure rates of the surgery as defined by intraocular pressure reductions

    Time frame: one year

    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.

Secondary outcomes

  1. Bleb morphology using Moorfields bleb grading system

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Maisonneuve-Rosemont Hospital

Other

Collaborators

  • Novartis

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
May 4, 2009
Registry last updated
Apr 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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