- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00853073
Does Adding Bevacizumab Therapy in Glaucoma Surgery Improve the Success of Needle Bleb Revisions? (Avastin)
June 7, 2018 updated by: Marlene Moster, MD, Wills Eye
Does a New Add on (or Adjunctive) Therapy Used in Glaucoma Surgery Improve the Success of Needle Bleb Revisions?
The purpose of this study is to see if a new add on (or adjunctive) therapy used in glaucoma surgery improves the success of needle bleb revisions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To investigate the efficacy of needle bleb revisions with mitomycin C with subconjunctival bevacizumab in promoting both filtering success and favorable bleb morphologic features.
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Wills Eye Institute, Glaucoma Service
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- require glaucoma bleb needle revision with Mitomycin-C
Exclusion Criteria:
- pregnant, nursing, or not using adequate contraception
- other glaucoma eye surgery involving tube shunts
- prior retinal detachments surgery with scleral buckle
- infection, inflammation, or any abnormality preventing eye pressure measurement
- enrolled in another investigational study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Bevacizumab
subjects will receive 1.0mg (0.04cc of 25 mg/ml) subconjunctival bevacizumab either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
|
1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure
Other Names:
|
Placebo Comparator: balanced salt solution
patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
|
0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraocular Pressure (IOP)
Time Frame: 6 months
|
mmHg (millimeters of mercury)
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Surgical Success
Time Frame: 6 months
|
Surgery was rated as complete success, qualified success or failure.
Complete success was defined as 20% (percent) reduction in eye pressure (IOP) without any IOP lowering medications.
Qualified success was defined as 20% reduction of IOP with IOP lowering medications.
Failure was defined as IOP greater than 21 mmHG (millimeters of mercury), less than 20% IOP reduction or need for additional surgery.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marlene R Moster, MD, Wills Eye
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
February 26, 2009
First Submitted That Met QC Criteria
February 26, 2009
First Posted (Estimate)
February 27, 2009
Study Record Updates
Last Update Posted (Actual)
July 9, 2018
Last Update Submitted That Met QC Criteria
June 7, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-867
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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