Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Weerawat Kiddee, Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01263834
First received: December 17, 2010
Last updated: January 30, 2014
Last verified: January 2014

December 17, 2010
January 30, 2014
December 2010
January 2014   (final data collection date for primary outcome measure)
Intraocular pressure [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01263834 on ClinicalTrials.gov Archive Site
  • Bleb characteristic grading [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  • systemic Blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Blood pressure and endothelial cell count [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome
The Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome: A Randomized Controlled Trial

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).

Prospective interventional clinical trial

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

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Glaucoma
  • Drug: Bevacizumab
    Bevacizumab injection of 1.25m/0.05 cc + Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application
    Other Name: Avastin
  • Drug: Mitomycin C
    Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application
    Other Name: MMC
  • Active Comparator: Mitomycin c
    Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application
    Intervention: Drug: Mitomycin C
  • Experimental: Bevacizumab
    Bevacizumab injection of 1.25m/0.05 cc + Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application
    Intervention: Drug: Bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01263834
EC 53-296-02-1-2
Yes
Weerawat Kiddee, Prince of Songkla University
Prince of Songkla University
Not Provided
Principal Investigator: Weerawat Kiddee, MD Prince of Songkla University
Prince of Songkla University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP