Trabeculectomy With Subconjunctival Bevacizumab Injection
Efficacy and Safety of Trabeculectomy With Subconjunctival Bevacizumab Versus Trabeculectomy With Mitomycin C.
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 7, 2011
CompletedFirst Posted
Study publicly available on registry
March 8, 2011
CompletedMarch 29, 2011
April 1, 2009
7 months
March 7, 2011
March 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
7-12 months
Secondary Outcomes (1)
Number of medications.
7-12 months
Study Arms (2)
Mitomycin C
SHAM COMPARATORThose with trabeculectomy and intraoperative application of mitomycin C.
Bevacizumab
ACTIVE COMPARATORThose with trabeculectomy and adjunctive intraoperative subconjunctival injection of bevacizumab.
Interventions
Both groups underwent trabeculectomy ,but in active group bevacizumab was used and in sham group mitomycin c was used during the surgery.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rassoul Akram hospital, eye research center
Tehran, Tehran Province, 14455-364, Iran
Related Publications (2)
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.
PMID: 18692246BACKGROUNDMemarzadeh 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.
PMID: 19182254BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 7, 2011
First Posted
March 8, 2011
Study Start
April 1, 2009
Primary Completion
November 1, 2009
Study Completion
July 1, 2010
Last Updated
March 29, 2011
Record last verified: 2009-04