Results of Adjunctive Intraoperative Bevacizumab Injectio... | NCT01263834

Studies
Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome

NCT01263834

Sponsor

Prince of Songkla University

Status

Completed

Last Update Posted

Jan 31, 2014Estimated

Enrollment

39Actual

Phase

Phase 2Phase 3

Conditions

Glaucoma

Interventions

Bevacizumab
Mitomycin C

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Dec 17, 2010

First Submission Date that Met QC Criteria

Dec 20, 2010

First Posted Date

Dec 21, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2014

Last Update Posted Date

Jan 31, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mitomycin c	Active Comparator	Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application	Drug: Mitomycin C
Bevacizumab	Experimental	Bevacizumab injection of 1.25m/0.05 cc + Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application	Drug: Bevacizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bevacizumab	Drug	Bevacizumab injection of 1.25m/0.05 cc + Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application	Bevacizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intraocular pressure		6 month

Secondary Outcomes

Measure	Description	Time Frame
Bleb characteristic grading		6 month
systemic Blood pressure		6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Weerawat Kiddee, MD	Prince of Songkla University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Glaucoma unit , Department of Ophthalmology Faculty of Medicine Prince of Songkla University		Hat Yai	Changwat Songkhla	90110	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068258	Bevacizumab
D016685	Mitomycin

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided