Use of Ranibizumab With Mitomycin C During Trabeculectomy (OCTOPUS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by University of Colorado, Denver.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00661583
First received: April 15, 2008
Last updated: December 4, 2012
Last verified: April 2008

April 15, 2008
December 4, 2012
April 2008
September 2013   (final data collection date for primary outcome measure)
to assess ocular adverse events of combination ranibizumab and MMC therapy at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00661583 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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)

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Trabeculectomy
  • Glaucoma
Drug: ranibizumab
0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed
Active Comparator: 1
standard of care
Intervention: Drug: ranibizumab
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. Epub 2010 Jun 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
September 2013
September 2013   (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
No
Contact: Malik Y. Kahook, MD 720-848-2500 malik.kahook@ucdenver.edu
Contact: Mary Preston 720-848-2035 mary.preston@ucdenver.edu
United States
 
NCT00661583
07-0921
No
University of Colorado, Denver
University of Colorado, Denver
Genentech
Study Director: Malik Y. Kahook, MD Rocky Mountain Lions Eye institute
University of Colorado, Denver
April 2008

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