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Completed

NCT Number: NCT01263834

Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome

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).

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Hat Yai, Changwat Songkhla, 90110, Thailand

About this study

Prospective interventional clinical trial

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Drug

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

Other names: Avastin

mitomycin C

Drug

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

Other names: MMC

Primary outcomes

  1. Intraocular pressure

    Time frame: 6 month

Secondary outcomes

  1. Bleb characteristic grading

    Time frame: 6 month

  2. systemic Blood pressure

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Official study title

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

Acronym: Bevacizumab

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 21, 2010
Registry last updated
Jan 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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