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Use of Ranibizumab With Mitomycin C During Trabeculectomy (OCTOPUS)

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00661583
First received: April 15, 2008
Last updated: August 19, 2016
Last verified: August 2016

April 15, 2008
August 19, 2016
April 2008
September 2014   (final data collection date for primary outcome measure)
Assessment of Ocular Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
To assess ocular adverse events of combination ranibizumab and MMC therapy at 6 months
to assess ocular adverse events of combination ranibizumab and MMC therapy at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00661583 on ClinicalTrials.gov Archive Site
  • Percent of Subjects With a Qualified Success and Viable Bleb at 6 Months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To determine percent of subjects with a qualified success and viable bleb at 6 months (IOP between 6mm Hg and 22 mm Hg with pressure controlled with and without adjunctive medications)
  • Mean Change in in Intraocular Pressure. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Mean change in in intraocular pressure at 3 months and at 6 months
  • Mean Change in Visual Acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Mean change in visual acuity in logMAR.
  • to determine percent of subjects with a qualified success and viable bleb at 6 months (IOP between 6mm Hg and 22 mm Hg with pressure controlled with and without adjunctive medications) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • to determine mean change in in intraocular pressure and in visual acuity at 3 months and at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Use of Ranibizumab With Mitomycin C During Trabeculectomy
Occlusion Prevention for Trabeculectomy Procedures Using Combination Ranibizumab and Mitomycin C (MMC) During Surgery (OCTOPUS Study)
The purpose of the study is to study the safety of the combination of ranibizumab and MMC vs monotherapy MMC vs intravitreal ranibizumab injection in patients with glaucoma.

A common problem after undergoing trabeculectomy surgery to create a bleb (blister or bubble) to reduce intraocular pressure, is scarring of the opening. This scarring prevents fluid drainage and interferes with the proper functioning of the bleb. MMC (Mitomycin C) is usually administered intraoperatively, to reduce scarring and increase filtration. However, the failure rate of trabeculectomy remains high. Anti-VEGF (Vascular endothelial growth factor) agents have been used successfully in cases requiring bleb needling. The purpose of the study is to determine the safety of the combination of ranibizumab and MMC vs monotherapy MMC in patients with glaucoma.

This is an open-label, Phase I/II safety study of 30 patients randomized to either treatment with ranibizumab 0.5 mg intravitreally injected (n=10), combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10) or MMC therapy alone (n=10).

For the ranibizumab groups, a repeat injection of ranibizumab 0.5mg may be given PRN (as needed) at 1 month if hypervascularity or neovascularization of the conjunctiva exists.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Glaucoma
  • Drug: Ranibizumab
    0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed
  • Drug: Ranibizumab and MMC
    Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy
    Other Name: Ranibizumab and Mitomycin C
  • Drug: MMC
    MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy.
    Other Name: Mitomycin C
  • Experimental: Ranibizumab alone
    Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)
    Intervention: Drug: Ranibizumab
  • Experimental: Ranibizumab and MMC
    Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)
    Intervention: Drug: Ranibizumab and MMC
  • Active Comparator: MMC alone
    MMC therapy alone (n=10)
    Intervention: Drug: MMC
Kahook MY. Bleb morphology and vascularity after trabeculectomy with intravitreal ranibizumab: a pilot study. Am J Ophthalmol. 2010 Sep;150(3):399-403.e1. doi: 10.1016/j.ajo.2010.03.025.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
September 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • glaucoma
  • undergoing trabeculectomy
  • 21 years of age or older

Exclusion Criteria:

  • pregnancy or lactation
  • any condition the investigator believes would impose a significant hazard to the patient if investigational therapy were initiated
  • history of ocular surface disease
  • cataract surgery in the past 6 months
  • history of active inflammatory, infectious or idiopathic keratitis
Both
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00661583
07-0921
No
No

Subject medical information obtained by this study is confidential, and disclosure to third parties other than those noted below is prohibited.

Upon the subject's permission, medical information may be given to his/her personal physician or other appropriate medical personnel responsible for his/her welfare.

Data generated by this study will be available for inspection upon request by representatives of the U.S. FDA, national and local health authorities, the drug manufacturer and the IRB/EC, if appropriate.

University of Colorado, Denver
University of Colorado, Denver
Genentech, Inc.
Study Director: Malik Y. Kahook, MD Rocky Mountain Lions Eye institute
University of Colorado, Denver
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP