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Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome (Bevacizumab)

Primary Purpose

Glaucoma

Status

Completed

Phase

Phase 2

Locations

Thailand

Study Type

Interventional

Intervention

Bevacizumab

Mitomycin C

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Trabeculectomy, bevacizumab, intraocular pressure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Mitomycin c

Bevacizumab

Arm Description

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

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

Outcomes

Primary Outcome Measures

Intraocular pressure

Secondary Outcome Measures

Bleb characteristic grading

systemic Blood pressure

Full Information

NCT ID

NCT01263834

First Posted

December 17, 2010

Last Updated

January 30, 2014

Sponsor

Prince of Songkla University

1. Study Identification

Unique Protocol Identification Number

NCT01263834

Brief Title

Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome

Acronym

Bevacizumab

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Prince of Songkla University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

Keywords

Trabeculectomy, bevacizumab, intraocular pressure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mitomycin c

Arm Type

Active Comparator

Arm Description

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

Arm Title

Bevacizumab

Arm Type

Experimental

Arm Description

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

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

Avastin

Intervention Description

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

Intervention Name(s)

Mitomycin C

Other Intervention Name(s)

MMC

Intervention Description

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

Primary Outcome Measure Information:

Title

Intraocular pressure

Time Frame

6 month

Secondary Outcome Measure Information:

Title

Bleb characteristic grading

Time Frame

6 month

Title

systemic Blood pressure

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Weerawat Kiddee, MD

Organizational Affiliation

Prince of Songkla University

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Hat-yai

State/Province

Songkhla

ZIP/Postal Code

90110

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome

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