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Status unknownNCT01122966bevazicumabUpdated May 26, 2010

The Effect of Bevacizumab on the Trabeculectomy

A Phase 2/3 interventional study of intraocular injections of bevacizumab in Glaucoma, sponsored by Samsung Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-05-26.

Sponsored by Samsung Medical Center · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study summary

The investigators plan to evaluate the additive effect of intracameral and subconjunctival injections of bevacizumab in trabeculectomies with other antimetabolites.

Read the 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.

02

Conditions studied

  • Glaucoma

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Keywords

  • trabeculectomy
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's planned enrollment of 40 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • glaucoma patients who have trabeculectomy

Exclusion criteria

Exclusion Criteria:

  • patients with the other ocular disease
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Other
    trabeculectomy

    Subjects who have trabeculectomies with intraocular bevacizumab injection

    Drug: intraocular injections of bevacizumab

Interventions

  • Drugintraocular injections of bevacizumab

    intracameral and subconjunctival injections

    Also known as: glaucoma filtering surgery

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: on postoperative 1month

Secondary outcomes

  1. 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.

    Time frame: on postoperative 6months, 12months, 18months, 24months

07

Study locations

1 of 1 sites recruiting
  • Samsung Medical Center
    Seoul, Korea, Republic of
    Recruiting
08

References and documents

Publications

  • 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. PubMed 19474408 ↗
  • 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. PubMed 18692246 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01122966
Lead sponsor
Samsung Medical Center
First posted
May 13, 2010
Start date
Mar 2010
Primary completion
Mar 2011 (estimated)
Completion
Mar 2012 (estimated)
Last update
May 26, 2010

Study contacts

Changwon Kee, M.D., Ph.D.
Contact
ckee@skku.edu
82-2-3410-3564
Wool Suh, M.D.
Contact
being111@hotmail.com
82-2-3410-3564
Changwon Kee, M.D., Ph.D
study chair · Samsung Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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