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The Effect of Bevacizumab on the Trabeculectomy (bevazicumab)

Primary Purpose

Glaucoma

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
intraocular injections of bevacizumab
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring trabeculectomy

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • glaucoma patients who have trabeculectomy

Exclusion Criteria:

  • patients with the other ocular disease

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

trabeculectomy

Arm Description

Subjects who have trabeculectomies with intraocular bevacizumab injection

Outcomes

Primary Outcome Measures

intraocular pressure
Intraocular pressure is planned to measure when the patient visit the clinic. All intraocular pressure measurements is acquired by glaucoma specialists, using a slitlamp-mounted Goldmann applanation tonometer.

Secondary Outcome Measures

intraocular pressure
Intraocular pressure is planned to measure when the patient visit the clinic. All intraocular pressure measurements is acquired by glaucoma specialists, using a slitlamp-mounted Goldmann applanation tonometer.

Full Information

First Posted
April 15, 2010
Last Updated
May 25, 2010
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01122966
Brief Title
The Effect of Bevacizumab on the Trabeculectomy
Acronym
bevazicumab
Official Title
The Effect of Intracameral and Subconjunctival Injections of Bevacizumab in Trabeculectomy With Antimetabolite
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2011 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators plan to evaluate the additive effect of intracameral and subconjunctival injections of bevacizumab in trabeculectomies with other antimetabolites.
Detailed Description
Glaucoma filtration surgery is routinely utilized to control intraocular pressure in glaucomatous patients. It reduces IOP by creating a fistula between the anterior chamber and the subconjunctival space with a filtering bleb. Increased wound healing response affects the function and morphology of the filtering bleb, and wound healing involves a series of biological events beginning with hemostasis. Corticosteroids and antifibrosis agents such as mitomycin C and 5-fluorouracil have been employed in trabeculectomy to delay wound healing and hence to improve the success rate of surgery by inhibiting inflammation and fibroblastic activity, and the use of these antiscarring agents is generally believed to improve the success rate of trabeculectomy.But this rate decreased with passing time and thus was not perfect. Vascular endothelial growth factor is a pivotal stimulator of angiogenesis because its binding to VEGF receptors has been demonstrated to promote endothelial cell migration and proliferation in wound healing.Therefore, anti-VEGF agents may potentially modulate wound healing following glaucoma filtration surgery. The principal objective of this study was to evaluate the additive effect of intracameral and subconjunctival injections of bevacizumab in trabeculectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
trabeculectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
trabeculectomy
Arm Type
Other
Arm Description
Subjects who have trabeculectomies with intraocular bevacizumab injection
Intervention Type
Drug
Intervention Name(s)
intraocular injections of bevacizumab
Other Intervention Name(s)
glaucoma filtering surgery
Intervention Description
intracameral and subconjunctival injections
Primary Outcome Measure Information:
Title
intraocular pressure
Description
Intraocular pressure is planned to measure when the patient visit the clinic. All intraocular pressure measurements is acquired by glaucoma specialists, using a slitlamp-mounted Goldmann applanation tonometer.
Time Frame
on postoperative 1month
Secondary Outcome Measure Information:
Title
intraocular pressure
Description
Intraocular pressure is planned to measure when the patient visit the clinic. All intraocular pressure measurements is acquired by glaucoma specialists, using a slitlamp-mounted Goldmann applanation tonometer.
Time Frame
on postoperative 6months, 12months, 18months, 24months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: glaucoma patients who have trabeculectomy Exclusion Criteria: patients with the other ocular disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Changwon Kee, M.D., Ph.D.
Phone
82-2-3410-3564
Email
ckee@skku.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Wool Suh, M.D.
Phone
82-2-3410-3564
Email
being111@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changwon Kee, M.D., Ph.D
Organizational Affiliation
Samsung Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changwon Kee, M.D., Ph.D.
Phone
82-2-3410-3564
Email
ckee@skku.edu
First Name & Middle Initial & Last Name & Degree
Wool Suh, M.D.
Phone
82-2-3410-3564
Email
being111@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
19474408
Citation
Li Z, Van Bergen T, Van de Veire S, Van de Vel I, Moreau H, Dewerchin M, Maudgal PC, Zeyen T, Spileers W, Moons L, Stalmans I. Inhibition of vascular endothelial growth factor reduces scar formation after glaucoma filtration surgery. Invest Ophthalmol Vis Sci. 2009 Nov;50(11):5217-25. doi: 10.1167/iovs.08-2662. Epub 2009 May 27.
Results Reference
background
PubMed Identifier
18692246
Citation
Grewal DS, Jain R, Kumar H, Grewal SP. Evaluation of subconjunctival bevacizumab as an adjunct to trabeculectomy a pilot study. Ophthalmology. 2008 Dec;115(12):2141-2145.e2. doi: 10.1016/j.ophtha.2008.06.009. Epub 2008 Aug 9.
Results Reference
background

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The Effect of Bevacizumab on the Trabeculectomy

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