NCT01425112

Brief Summary

Bevacizumab is an anti vascular endothelial growth factor(anti-VEGF) substance that is known to reduce neovascularization and fibrovascular proliferation in inflammatory conditions, including post-operative inflammation. It has shown efficacy in numerous ocular conditions(off-label), that includes Age related macular degeneration, proliferative diabetic retinopathy, neovascular glaucoma and corneal neovascularization. It is being explored as an option for preventing recurrence of pterygium and as an adjunct to improving outcomes of trabeculectomy. There is a debate as to the mode and duration of bevacizumab administration for trabeculectomy. This study aims to compare a single subconjunctival dose of bevacizumab with topical therapy over one month in terms of outcomes of trabeculectomy surgery, non-progression of field loss and stable intraocular pressure(IOP) control.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2007

Longer than P75 for not_applicable

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, 2007

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2011

Completed
Last Updated

August 29, 2011

Status Verified

August 1, 2011

Enrollment Period

3.4 years

First QC Date

August 25, 2011

Last Update Submit

August 26, 2011

Conditions

Complications of TreatmentProgression

Keywords

trabeculectomybevacizumabanti-VEGFEfficacy

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure control

    For 2 years

Secondary Outcomes (1)

  • Progression

    2 years

Study Arms (1)

Topical/Subconjunctival

EXPERIMENTAL

Depending upon the mode of administration

Procedure: Phacoemulsification

Interventions

PhacoemulsificationPROCEDURE

Surgery for complications of trabeculectomy

Topical/Subconjunctival

Eligibility Criteria

Age42 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary Open Angle Glaucoma
  • Progression
  • Failure to reach target IOP
  • Non compliant

You may not qualify if:

  • Resurgery
  • Systemic contraindication to bevacizumab
  • All other forms of glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Disease Progression

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Aditya Anand Sudhalkar

Study Record Dates

First Submitted

August 25, 2011

First Posted

August 29, 2011

Study Start

December 1, 2007

Primary Completion

May 1, 2011

Study Completion

June 1, 2011

Last Updated

August 29, 2011

Record last verified: 2011-08