Use of Ranibizumab With Mitomycin C During Trabeculectomy (OCTOPUS)
Primary Purpose
Glaucoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab
Ranibizumab and MMC
MMC
Sponsored by

About this trial
This is an interventional treatment trial for Glaucoma focused on measuring trabeculectomy, glaucoma, ranibizumab
Eligibility 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
Sites / Locations
- Rocky Mountain Lions Eye Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Ranibizumab alone
Ranibizumab and MMC
MMC alone
Arm Description
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)
MMC therapy alone (n=10)
Outcomes
Primary Outcome Measures
Assessment of Ocular Adverse Events
To assess ocular adverse events of combination ranibizumab and MMC therapy at 6 months
Secondary Outcome Measures
Percent of Subjects With a Qualified Success and Viable Bleb at 6 Months.
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.
Mean change in in intraocular pressure at 3 months and at 6 months
Mean Change in Visual Acuity
Mean change in visual acuity in logMAR.
Full Information
NCT ID
NCT00661583
First Posted
April 15, 2008
Last Updated
August 19, 2016
Sponsor
University of Colorado, Denver
Collaborators
Genentech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00661583
Brief Title
Use of Ranibizumab With Mitomycin C During Trabeculectomy
Acronym
OCTOPUS
Official Title
Occlusion Prevention for Trabeculectomy Procedures Using Combination Ranibizumab and Mitomycin C (MMC) During Surgery (OCTOPUS Study)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Genentech, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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 (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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
trabeculectomy, glaucoma, ranibizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ranibizumab alone
Arm Type
Experimental
Arm Description
Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)
Arm Title
Ranibizumab and MMC
Arm Type
Experimental
Arm Description
Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)
Arm Title
MMC alone
Arm Type
Active Comparator
Arm Description
MMC therapy alone (n=10)
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Intervention Description
0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed
Intervention Type
Drug
Intervention Name(s)
Ranibizumab and MMC
Other Intervention Name(s)
Ranibizumab and Mitomycin C
Intervention Description
Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy
Intervention Type
Drug
Intervention Name(s)
MMC
Other Intervention Name(s)
Mitomycin C
Intervention Description
MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy.
Primary Outcome Measure Information:
Title
Assessment of Ocular Adverse Events
Description
To assess ocular adverse events of combination ranibizumab and MMC therapy at 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percent of Subjects With a Qualified Success and Viable Bleb at 6 Months.
Description
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
Title
Mean Change in in Intraocular Pressure.
Description
Mean change in in intraocular pressure at 3 months and at 6 months
Time Frame
6 months
Title
Mean Change in Visual Acuity
Description
Mean change in visual acuity in logMAR.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malik Y. Kahook, MD
Organizational Affiliation
Rocky Mountain Lions Eye institute
Official's Role
Study Director
Facility Information:
Facility Name
Rocky Mountain Lions Eye Institute
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
20570237
Citation
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.
Results Reference
derived
Learn more about this trial
Use of Ranibizumab With Mitomycin C During Trabeculectomy
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