Subconjunctival Bevacizumab Effect on Bleb Vascularity
Subconjunctival Bevacizumab Injection for the Prevention of Bleb Vascularization Post Trabeculectomy
Trabeculectomy is an ocular surgery intended to reduce intra-ocular pressure the surgery creates a sub-conjunctival filtering bleb which filters aqueous humor fluid out.
A rather common adverse event of the surgery is increasing vascularity of the conjunctiva overlying the bleb. This leads to adherence of the conjunctiva to the sclera and fibrosis and finally failure of the bleb (and of the surgery) this study intends to demonstrate that post operative subconjunctival bevacizumab injection will reduce incidence of bleb vascularity and ultimately, bleb failure.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
trabeculectomy is an ocular surgery intended to reduce intra-ocular pressure the surgery creates a sub-conjunctival filtering bleb which filters aqueous humor fluid out.
a rather common adverse event of the surgery is increasing vascularity of the conjunctiva overlying the bleb. this leads to adherence of the conjunctiva to the sclera and fibrosis and finally failure of the bleb (and of the surgery) this study wishes to demonstrate that post operative subconjunctival bevacizumab injection will reduce incidence of bleb vascularity and ultimately, bleb failure.
during the study, one study group will be given subconjunctival bevacizumab 1 week after surgery, another study group will be given subconjunctival bevacizumab 2 week after surgery, and a third group will serve as control and will not receive bevacizumab. if bleb vascularity will be diagnosed all patients will be treated according to current guidelines.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Petah-tikva, Israel, 49100
- Rabin Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- post uneventful trabeculectomy with mitomycin c application during surgery
- adult
Exclusion Criteria:
- usage of 5-fluorouracil in trabeculectomy
- post-operative complications
- ischemic heart disease
- s/p cerebrovascular accident
- allergy to bevacizumab
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: 1
20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 1 week after the surgery
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sub-conjunctival injection of 1.25mg Bevacizumab
Other Names:
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ACTIVE_COMPARATOR: 2
20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 2 weeks after the surgery
|
sub-conjunctival injection of 1.25mg Bevacizumab
Other Names:
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NO_INTERVENTION: 3
20 patients after an uneventful trabeculectomy with usage of mitomycin C, will not receive any bevacizumab injection.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Bleb vascularity grading
Time Frame: 1, 2, 3, 4, 5. 6. montes post operative.
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1, 2, 3, 4, 5. 6. montes post operative.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Indiana Bleb Appearance Grading Scale (IBAGS)
Time Frame: 1, 2, 3, 4, 5, 6 months post operative
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1, 2, 3, 4, 5, 6 months post operative
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Intra-ocular pressure
Time Frame: 1, 2, 3, 4, 5, 6 months post operative
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1, 2, 3, 4, 5, 6 months post operative
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Indication for subconjunctival Mitomycin C injection or revision of surgery = yes / no
Time Frame: 1, 2, 3, 4, 5, 6 months post operative
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1, 2, 3, 4, 5, 6 months post operative
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: moshe lusky, MD, Rabin Medical Center
- Study Chair: omer Y bialer, MD, rabin medial center
- Study Chair: anat robinson, MD, Rabin Medical Center
Publications and helpful links
General Publications
- Ichhpujani P, Ramasubramanian A, Kaushik S, Pandav SS. Bevacizumab in glaucoma: a review. Can J Ophthalmol. 2007 Dec;42(6):812-5. doi: 10.3129/i07-160.
- Schwartz AL, Van Veldhuisen PC, Gaasterland DE, Ederer F, Sullivan EK, Cyrlin MN. The Advanced Glaucoma Intervention Study (AGIS): 5. Encapsulated bleb after initial trabeculectomy. Am J Ophthalmol. 1999 Jan;127(1):8-19. doi: 10.1016/s0002-9394(98)00290-6.
- 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.
- Coote MA, Ruddle JB, Qin Q, Crowston JG. Vascular changes after intra-bleb injection of bevacizumab. J Glaucoma. 2008 Oct-Nov;17(7):517-8. doi: 10.1097/IJG.0b013e31815f5345.
- Kahook MY, Schuman JS, Noecker RJ. Needle bleb revision of encapsulated filtering bleb with bevacizumab. Ophthalmic Surg Lasers Imaging. 2006 Mar-Apr;37(2):148-50.
- Treatment of Failing Blebs with Ranibizumab. Study number NCT00570726. http://clinicaltrials.gov
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 005285
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