NCT01263834

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 21, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 31, 2014

Status Verified

January 1, 2014

Enrollment Period

3.1 years

First QC Date

December 17, 2010

Last Update Submit

January 30, 2014

Conditions

Glaucoma

Keywords

Trabeculectomybevacizumabintraocular pressure

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure

    6 month

Secondary Outcomes (2)

  • Bleb characteristic grading

    6 month

  • systemic Blood pressure

    6 months

Study Arms (2)

Mitomycin c

ACTIVE COMPARATOR

Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application

Drug: Mitomycin C

Bevacizumab

EXPERIMENTAL

Bevacizumab injection of 1.25m/0.05 cc + Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application

Drug: Bevacizumab

Interventions

BevacizumabDRUG

Bevacizumab injection of 1.25m/0.05 cc + Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application

Also known as: Avastin
Bevacizumab
Mitomycin CDRUG

Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application

Also known as: MMC
Mitomycin c

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary open angle glaucoma with primary mmc-trabeculectomy indication

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glaucoma unit , Department of Ophthalmology Faculty of Medicine Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Glaucoma

Interventions

BevacizumabMitomycin

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsMitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Weerawat Kiddee, MD

    Prince of Songkla University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.Weerawat Kiddee

Study Record Dates

First Submitted

December 17, 2010

First Posted

December 21, 2010

Study Start

December 1, 2010

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 31, 2014

Record last verified: 2014-01

Locations

TH(1)