Subconjunctival Bevacizumab Effect on Bleb Vascularity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bleb Vascularity Change After Subconjunctival Injection Bevacizumab

NCT00815594

Bleb Vascularity Conjunctival Scarring

UNKNOWN PHASE4

Bevacizumab for the Treatment of Corneal Neovascularization

NCT00992849

Corneal Neovascularization

UNKNOWN PHASE2

Trabeculectomy With Subconjunctival Bevacizumab Injection

NCT01310764

Glaucoma

COMPLETED NA

Comparison of Subconjuctival Versus Topical Bevacizumab as Adjunct Therapy to Trabeculectomy

NCT01425112

Complications of Treatment Progression

COMPLETED NA

The Effect of Bevacizumab on Corneal Neovascularization

NCT00797303

Corneal Neovascularization

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bleb Vascularity Bleb Fibrosis Trabeculectomy Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 1 week after the surgery

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

sub-conjunctival injection of 1.25mg Bevacizumab

2

20 patients who had an uneventful trabeculectomy with usage of mitomycin C, will receive subconjunctival bevacizumab 2 weeks after the surgery

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type DRUG

sub-conjunctival injection of 1.25mg Bevacizumab

3

20 patients after an uneventful trabeculectomy with usage of mitomycin C, will not receive any bevacizumab injection.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bevacizumab

sub-conjunctival injection of 1.25mg Bevacizumab

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Avastin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No