Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome

Glaucoma Clinical Trial

— Bevacizumab  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01263834
• Other study ID #: EC 53-296-02-1-2
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 17, 2010
• Last updated: January 30, 2014
• Start date: December 2010
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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).

Description:

Prospective interventional clinical trial

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

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

Locations

Country	Name	City	State
Thailand	Glaucoma unit , Department of Ophthalmology Faculty of Medicine Prince of Songkla University	Hat-yai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure		6 month	No
Secondary	Bleb characteristic grading		6 month	Yes
Secondary	systemic Blood pressure		6 months	Yes