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Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome

Information source: Prince of Songkla University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glaucoma

Intervention: Bevacizumab (Drug); Mitomycin C (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Prince of Songkla University

Official(s) and/or principal investigator(s):
Weerawat Kiddee, MD, Principal Investigator, Affiliation: Prince of Songkla University

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).

Clinical Details

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

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

Primary outcome: Intraocular pressure

Secondary outcome:

Bleb characteristic grading

systemic Blood pressure

Detailed description: Prospective interventional clinical trial Single center, outcome assessor-masked, active control, randomized controlled trial

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Glaucoma unit , Department of Ophthalmology Faculty of Medicine Prince of Songkla University, Hat-yai, Songkhla 90110, Thailand
Additional Information

Starting date: December 2010
Last updated: January 30, 2014

Page last updated: August 23, 2015

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