Subconjunctival Bevacizumab Effect on Bleb Vascularity

Study Overview
=================
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.

Official Title
-----------------
Subconjunctival Bevacizumab Injection for the Prevention of Bleb Vascularization Post Trabeculectomy

Conditions
-----------------
Bleb Vascularity, Bleb Fibrosis, Trabeculectomy Failure

Intervention / Treatment
-----------------
* Drug: Bevacizumab


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 1 week after the surgery | Drug: Bevacizumab<br>* sub-conjunctival injection of 1.25mg Bevacizumab<br>* Other names: Avastin;|
| Active Comparator: 2<br>20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 2 weeks after the surgery | Drug: Bevacizumab<br>* sub-conjunctival injection of 1.25mg Bevacizumab<br>* Other names: Avastin;|
| No Intervention: 3<br>20 patients after an uneventful trabeculectomy with usage of mitomycin C, will not receive any bevacizumab injection. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleb vascularity grading |  | 1, 2, 3, 4, 5. 6. montes post operative. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indiana Bleb Appearance Grading Scale (IBAGS) |  | 1, 2, 3, 4, 5, 6 months post operative | 
| Intra-ocular pressure |  | 1, 2, 3, 4, 5, 6 months post operative | 
| Indication for subconjunctival Mitomycin C injection or revision of surgery = yes / no |  | 1, 2, 3, 4, 5, 6 months post operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bevacizumab, subconjunctival injection, trabeculectomy, bleb, mitomycin c