Clinical trial NCT00854529: Subconjunctival Bevacizumab Effect on Bleb Vascularity
Official title: Subconjunctival Bevacizumab Injection for the Prevention of Bleb Vascularization Post Trabeculectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bleb Vascularity
Bleb Fibrosis
Trabeculectomy Failure
Keywords: bevacizumab
subconjunctival injection
trabeculectomy
bleb
mitomycin c
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2009-03-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bleb vascularity grading
timeFrame: 1, 2, 3, 4, 5. 6. montes post operative.
Secondary outcomes:
measure: Indiana Bleb Appearance Grading Scale (IBAGS)
timeFrame: 1, 2, 3, 4, 5, 6 months post operative
measure: Intra-ocular pressure
timeFrame: 1, 2, 3, 4, 5, 6 months post operative
measure: Indication for subconjunctival Mitomycin C injection or revision of surgery = yes / no
timeFrame: 1, 2, 3, 4, 5, 6 months post operative
Other outcomes:
Locations:
city: Petah-tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: moshe lusky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: rabin medial center
name: omer Y bialer, MD
role: STUDY_CHAIR
affiliation: Rabin Medical Center
name: anat robinson, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
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.
citation: 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.
citation: 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.
citation: Treatment of Failing Blebs with Ranibizumab. Study number NCT00570726. http://clinicaltrials.gov