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: April 18, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention Phase
Glaucoma
Drug: Ranibizumab
Drug: Ranibizumab and MMC
Drug: MMC
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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
Experimental: Ranibizumab alone
Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)
Drug: Ranibizumab
0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed
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)
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
Active Comparator: MMC alone
MMC therapy alone (n=10)
Drug: MMC
MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy.
Other Name: Mitomycin C

Detailed Description:

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 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 at 1 month if hypervascularity or neovascularization of the conjunctiva exists.

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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: April 18, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No
Plan Description:

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.


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

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Ranibizumab
Mitomycins
Mitomycin
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antibiotics, Antineoplastic
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 21, 2016