Trabeculectomy With Subconjunctival Bevacizumab Injection
Primary Purpose
Glaucoma
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Trabeculectomy
Sponsored by

About this trial
This is an interventional treatment trial for Glaucoma focused on measuring Intraocular pressure, Trabeculectomy, Mitomycin C, Bevacizumab
Eligibility Criteria
Inclusion Criteria:
- Uncontrolled Open angle glaucoma.
- Glaucoma patients who are non-compliant to medical treatment.
- Progressive glaucoma despite of medical treatment.
- Follow-up of at least 6 months after surgery
Exclusion Criteria:
- History of prior ocular surgery.
- Pregnancy or breast feeding.
- Age < 18 years.
- History of ocular surface infection in recent two weeks.
- History of systemic thrombo-embolic events.
Sites / Locations
- Rassoul Akram hospital, eye research center
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Mitomycin C
Bevacizumab
Arm Description
Those with trabeculectomy and intraoperative application of mitomycin C.
Those with trabeculectomy and adjunctive intraoperative subconjunctival injection of bevacizumab.
Outcomes
Primary Outcome Measures
Intraocular pressure.
Pre and post operative intraocular pressures are measured with Goldmann applanation tonometer at each time point visits and the measurement were compared between both groups.
Secondary Outcome Measures
Number of medications.
Number of pre and post operative medications were recorded and compared in each post operative visits.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01310764
Brief Title
Trabeculectomy With Subconjunctival Bevacizumab Injection
Official Title
Efficacy and Safety of Trabeculectomy With Subconjunctival Bevacizumab Versus Trabeculectomy With Mitomycin C.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Rassoul Akram Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate the safety and efficacy of bevacizumab as an adjunctive treatment to trabeculectomy in open angle glaucoma patients and to compare this new drug to the most commonly used anti-scarring agent, mitomycin C.
Detailed Description
The most common surgical technique for controlling the intraocular pressure in glaucoma patients is trabeculectomy.In this surgery, internal cavity of the eye is connected by a fistula like openings to subconjunctival space. The main cause of failure in trabeculectomy is excessive postoperative conjunctival scarring at the site of fistula, which is related to severity of conjunctival vascularization, tortuousity of vessel, and fibroblast migration and proliferation. At the time of surgery most surgeons use mitomycin C, which is an antimitotic and antifibrotic agent, to improve the results of the procedure. Although this agent is very effective, but is not without complication. The most significant and sight threatening complications are low intraocular pressure and endophthalmitis. Therefore investigations are going on to find a much safer and effective agents. Bevacizumab is a monoclonal antibody against vascular endothelial factor (VEGF). VEGF is an important vasculogenic and fibrogenic factor with a prominent role in wound healing.Bevacizumab is widely used in ophthalmology and has a promising effect in treatment of neovascularization in conjunctiva, cornea and retina. There are limited animal and human case series regarding the effect of this agent in trabeculectomy. In this study the investigators are trying, in addition to evaluating the efficacy and safety of this agent in result of trabeculectomy, compare this agent with mitomycin C.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Intraocular pressure, Trabeculectomy, Mitomycin C, Bevacizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mitomycin C
Arm Type
Sham Comparator
Arm Description
Those with trabeculectomy and intraoperative application of mitomycin C.
Arm Title
Bevacizumab
Arm Type
Active Comparator
Arm Description
Those with trabeculectomy and adjunctive intraoperative subconjunctival injection of bevacizumab.
Intervention Type
Procedure
Intervention Name(s)
Trabeculectomy
Intervention Description
Both groups underwent trabeculectomy ,but in active group bevacizumab was used and in sham group mitomycin c was used during the surgery.
Primary Outcome Measure Information:
Title
Intraocular pressure.
Description
Pre and post operative intraocular pressures are measured with Goldmann applanation tonometer at each time point visits and the measurement were compared between both groups.
Time Frame
7-12 months
Secondary Outcome Measure Information:
Title
Number of medications.
Description
Number of pre and post operative medications were recorded and compared in each post operative visits.
Time Frame
7-12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Uncontrolled Open angle glaucoma.
Glaucoma patients who are non-compliant to medical treatment.
Progressive glaucoma despite of medical treatment.
Follow-up of at least 6 months after surgery
Exclusion Criteria:
History of prior ocular surgery.
Pregnancy or breast feeding.
Age < 18 years.
History of ocular surface infection in recent two weeks.
History of systemic thrombo-embolic events.
Facility Information:
Facility Name
Rassoul Akram hospital, eye research center
City
Tehran
ZIP/Postal Code
14455-364
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
18692246
Citation
Grewal DS, Jain R, Kumar H, Grewal SP. Evaluation of subconjunctival bevacizumab as an adjunct to trabeculectomy a pilot study. Ophthalmology. 2008 Dec;115(12):2141-2145.e2. doi: 10.1016/j.ophtha.2008.06.009. Epub 2008 Aug 9.
Results Reference
background
PubMed Identifier
19182254
Citation
Memarzadeh F, Varma R, Lin LT, Parikh JG, Dustin L, Alcaraz A, Eliott D. Postoperative use of bevacizumab as an antifibrotic agent in glaucoma filtration surgery in the rabbit. Invest Ophthalmol Vis Sci. 2009 Jul;50(7):3233-7. doi: 10.1167/iovs.08-2441. Epub 2009 Jan 31.
Results Reference
background
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Trabeculectomy With Subconjunctival Bevacizumab Injection
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