Use of Ranibizumab With Mitomycin C During Trabeculectomy (OCTOPUS)
Occlusion Prevention for Trabeculectomy Procedures Using Combination Ranibizumab and Mitomycin C (MMC) During Surgery (OCTOPUS Study)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Rocky Mountain Lions Eye Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Ranibizumab alone
Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)
|
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)
|
Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy
Other Names:
|
|
ACTIVE_COMPARATOR: MMC alone
MMC therapy alone (n=10)
|
MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of Ocular Adverse Events
Time Frame: 6 months
|
To assess ocular adverse events of combination ranibizumab and MMC therapy at 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent of Subjects With a Qualified Success and Viable Bleb at 6 Months.
Time Frame: 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)
|
6 months
|
|
Mean Change in in Intraocular Pressure.
Time Frame: 6 months
|
Mean change in in intraocular pressure at 3 months and at 6 months
|
6 months
|
|
Mean Change in Visual Acuity
Time Frame: 6 months
|
Mean change in visual acuity in logMAR.
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Malik Y. Kahook, MD, Rocky Mountain Lions Eye Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Eye Diseases
- Ocular Hypertension
- Glaucoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Alkylating Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Antibiotics, Antineoplastic
- Ranibizumab
- Mitomycins
- Mitomycin
Other Study ID Numbers
- 07-0921
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD 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.
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