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Use of Ranibizumab With Mitomycin C During Trabeculectomy (OCTOPUS)

This study is currently recruiting participants.
Verified April 2008 by University of Colorado, Denver
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
History of Changes
  Purpose

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
Trabeculectomy
Glaucoma
 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:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

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 ]

Estimated Enrollment: 30
Study Start Date: April 2008
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00661583

Contacts
Contact: Malik Y. Kahook, MD 720-848-2500 malik.kahook@ucdenver.edu
Contact: Mary Preston 720-848-2035 mary.preston@ucdenver.edu

Locations
United States, Colorado
Rocky Mountain Lions Eye Institute Recruiting
Aurora, Colorado, United States, 80045
Contact: Malik Y. Kahook, MD     720-848-2500     malik.kahook@ucdenver.edu    
Contact: Mary Preston     720-848-2035     Mary.Preston@ucdenver.edu    
Sub-Investigator: Mina Pantcheva, MD            
Sponsors and Collaborators
University of Colorado, Denver
Genentech
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00661583     History of Changes
Other Study ID Numbers: 07-0921
Study First Received: April 15, 2008
Last Updated: December 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Colorado, Denver:
trabeculectomy
glaucoma
ranibizumab

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents

ClinicalTrials.gov processed this record on May 16, 2013