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
  Purpose

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).


Condition Intervention Phase
Glaucoma
Drug: Bevacizumab
Drug: Mitomycin C
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • Intraocular pressure [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bleb characteristic grading [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  • systemic Blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 39
Study Start Date: December 2010
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mitomycin c
Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application
Drug: Mitomycin C
Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application
Other Name: MMC
Experimental: Bevacizumab
Bevacizumab injection of 1.25m/0.05 cc + Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application
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

Detailed Description:

Prospective interventional clinical trial

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01263834

Locations
Thailand
Glaucoma unit , Department of Ophthalmology Faculty of Medicine Prince of Songkla University
Hat-yai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Investigators
Principal Investigator: Weerawat Kiddee, MD Prince of Songkla University
  More Information

No publications provided

Responsible Party: Weerawat Kiddee, Dr.Weerawat Kiddee, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01263834     History of Changes
Other Study ID Numbers: EC 53-296-02-1-2
Study First Received: December 17, 2010
Last Updated: January 30, 2014
Health Authority: Thailand: Ethical Committee

Keywords provided by Prince of Songkla University:
Trabeculectomy
bevacizumab
intraocular pressure

Additional relevant MeSH terms:
Bevacizumab
Mitomycin
Mitomycins
Alkylating Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014