Subconjunctival Bevacizumab Effect on Bleb Vascularity

Bleb Vascularity Clinical Trial

Official title:

Subconjunctival Bevacizumab Injection for the Prevention of Bleb Vascularization Post Trabeculectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00854529
• Other study ID #: 005285
• Status: Not yet recruiting
• Phase: Phase 2
• First received: March 1, 2009
• Last updated: March 2, 2009
• Start date: April 2009
• Est. completion date: October 2011

Study information

• Verified date: February 2009
• Source: Rabin Medical Center
• Contact: moshe lusky, MD
• Phone: 972-39376113
• Email: moshel[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bleb Fibrosis
• Bleb Vascularity
• Blister
• Trabeculectomy Failure

Intervention

Drug:
• Bevacizumab
sub-conjunctival injection of 1.25mg Bevacizumab

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petah-tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (5)

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. — View 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. — View Citation

Ichhpujani P, Ramasubramanian A, Kaushik S, Pandav SS. Bevacizumab in glaucoma: a review. Can J Ophthalmol. 2007 Dec;42(6):812-5. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleb vascularity grading		1, 2, 3, 4, 5. 6. montes post operative.	No
Secondary	Indiana Bleb Appearance Grading Scale (IBAGS)		1, 2, 3, 4, 5, 6 months post operative	No
Secondary	Intra-ocular pressure		1, 2, 3, 4, 5, 6 months post operative	No
Secondary	Indication for subconjunctival Mitomycin C injection or revision of surgery = yes / no		1, 2, 3, 4, 5, 6 months post operative	No