Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome

This study is currently recruiting participants.

Verified January 2013 by Prince of Songkla University

Sponsor:

Information provided by (Responsible Party):

Weerawat Kiddee, Prince of Songkla University

ClinicalTrials.gov Identifier:

NCT01263834

First received: December 17, 2010

Last updated: January 16, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 17, 2010

Last Updated Date

January 16, 2013

Start Date ^ICMJE

December 2010

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Intraocular pressure [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01263834 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Bleb characteristic grading [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
systemic Blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Blood pressure and endothelial cell count [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome

Official Title ^ICMJE

The Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome: A Randomized Controlled Trial

Brief Summary

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

Prospective interventional clinical trial

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Glaucoma

Intervention ^ICMJE

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

Other Name: Avastin
Drug: Mitomycin C
Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application

Other Name: MMC

Study Arm (s)

Active Comparator: Mitomycin c
Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application

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

Intervention: Drug: Bevacizumab

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2014

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Primary open angle glaucoma or
Primary angle closure glaucoma with 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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: WEERAWAT KIDDEE, MD

66-1271-0644

kweerawat@hotmail.com

Location Countries ^ICMJE

Thailand

Administrative Information

NCT Number ^ICMJE

NCT01263834

Other Study ID Numbers ^ICMJE

EC 53-296-02-1-2

Has Data Monitoring Committee

Yes

Responsible Party

Weerawat Kiddee, Prince of Songkla University

Study Sponsor ^ICMJE

Prince of Songkla University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Weerawat Kiddee, MD

Prince of Songkla University

Information Provided By

Prince of Songkla University

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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