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Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome

This study is currently recruiting participants.
Verified January 2013 by Prince of Songkla University
Sponsor:
Information provided by (Responsible Party):
Weerawat Kiddee, Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01263834
First received: December 17, 2010
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  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:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

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 ]

Estimated Enrollment: 38
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 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 or
  • Primary angle closure glaucoma with 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01263834

Contacts
Contact: WEERAWAT KIDDEE, MD 66-1271-0644 kweerawat@hotmail.com

Locations
Thailand
Glaucoma unit , Department of Ophthalmology Faculty of Medicine Prince of Songkla University Recruiting
Hat-yai, Songkhla, Thailand, 90110
Contact: WEERAWAT KIDDEE, MD     66-81271-0644     kweerawat@hotmail.com    
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 16, 2013
Health Authority: Thailand: Ethical Committee

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

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

ClinicalTrials.gov processed this record on May 23, 2013