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

Sponsor
Maisonneuve-Rosemont Hospital
Study ID
NCT00892398
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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.
  • standard care — PROCEDURE
    standard post-operative care after trabeculectomy with mitomycin C

Study Details

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.

Key Dates

First listed
May 4, 2009
Start date
Mar 31, 2009
Status verified
Apr 2014
Primary completion
Oct 31, 2013
Completion
Mar 31, 2014

Study Design

Enrollment
242 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ranibizumab
    Trabeculectomy with mitomycin C associated with 2 subconjunctival injections of ranibizumab: 1 intraoperatively and 1 at 2 weeks post-operatively
  • Active Comparator: standard care
    Trabeculectomy with mitomycin C and standard post-operative care

Primary Outcome Measure

Failure rates of the surgery as defined by intraocular pressure reductions [ Time Frame: one year ]

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