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Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome

NCT ID: NCT01263834

Last Updated: 2014-01-31

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2014-01-31

Brief Summary

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The purpose of this study is to evaluate the adjunctive effect of intratenon Bevacizumab on the result of trabeculectomy in primary term of intraocular pressure (IOP).

Detailed Description

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Prospective interventional clinical trial

Single center, outcome assessor-masked, active control, randomized controlled trial

Conditions

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Glaucoma

Keywords

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Trabeculectomy bevacizumab intraocular pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mitomycin c

Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application

Group Type ACTIVE_COMPARATOR

Mitomycin C

Intervention Type DRUG

Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application

Bevacizumab

Bevacizumab injection of 1.25m/0.05 cc + Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

Bevacizumab injection of 1.25m/0.05 cc + Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application

Interventions

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Bevacizumab

Bevacizumab injection of 1.25m/0.05 cc + Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application

Intervention Type DRUG

Mitomycin C

Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application

Intervention Type DRUG

Other Intervention Names

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Avastin MMC

Eligibility Criteria

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Inclusion Criteria

* Primary open angle glaucoma with primary mmc-trabeculectomy indication

Exclusion Criteria

* combined phacoemulsification with trabeculectomy
* no more than 6 month of cataract surgery before trabeculectomy
* revised trabeculectomy
* active uveitic glaucoma
* neovascular glaucoma
* par planar vitrectomy
* conjunctival surgery
* allergy to bevacizumab or mitomycin C
* ischemic heart disease
* cerebrovascular disease
* renal failure
* liver failure
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

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Weerawat Kiddee

Dr.Weerawat Kiddee

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weerawat Kiddee, MD

Role: PRINCIPAL_INVESTIGATOR

Prince of Songkla University

Locations

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Glaucoma unit , Department of Ophthalmology Faculty of Medicine Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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EC 53-296-02-1-2

Identifier Type: -

Identifier Source: org_study_id