Use of Ranibizumab With Mitomycin C During Trabeculectomy (OCTOPUS)

This study has been completed.
Genentech, Inc.
Information provided by (Responsible Party):
University of Colorado, Denver Identifier:
First received: April 15, 2008
Last updated: May 27, 2015
Last verified: May 2015

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 function of the bleb. This study will add ranibizumab to the standard of care treatment as ranibizumab may compliment mitomycin C in the prevention of scarring at the bleb site potentially adding to the effectiveness of mitomycin C.

The study will access ocular adverse events of adding ranibizumab to standard of care treatment at 6 months after trabeculectomy.

Condition Intervention
Drug: ranibizumab

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Occlusion Prevention for TrabeculectOmy Procedures Using Combination Ranibizumab and Mitomycin C (MMC) During Surgery (OCTOPUS Study)

Resource links provided by NLM:

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • to assess ocular adverse events of combination ranibizumab and MMC therapy at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: April 2008
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
standard of care
Drug: ranibizumab
0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed


Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00661583

United States, Colorado
Rocky Mountain Lions Eye Institute
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Genentech, Inc.
Study Director: Malik Y. Kahook, MD Rocky Mountain Lions Eye institute
  More Information

No publications provided by University of Colorado, Denver

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Colorado, Denver Identifier: NCT00661583     History of Changes
Other Study ID Numbers: 07-0921 
Study First Received: April 15, 2008
Last Updated: May 27, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Colorado, Denver:
ranibizumab processed this record on February 04, 2016