NCT00384631

Brief Summary

Several studies have confirmed high levels of vascular endothelial growth factor (VEGF) in eyes with neovascular glaucoma (NVG). The role of VEGF inhibitors in regression of other neovascular disorders such as wet-type age-related macular degeneration and diabetic macular edema has been described. We aim to evaluate the effect of three intravitreal injections of bevacizumab (Avastin) 2.5 mg versus a sham procedure for treatment of NVG. Outcome measures include intraocular pressure and extent of iris neovascularization. Both study arms will receive conventional treatment for NVG.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2006

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

February 15, 2008

Status Verified

February 1, 2008

First QC Date

October 4, 2006

Last Update Submit

February 14, 2008

Conditions

NeovascularGlaucoma

Keywords

NeovascularGlaucomaBevacizumabAvastinIntravitrealIOP

Outcome Measures

Primary Outcomes (2)

  • Change in intraocular pressure

    6 months

  • Change in extent of iris neovascularization

    6 months

Secondary Outcomes (1)

  • Best corrected visual acuity

    6 months

Study Arms (2)

2

SHAM COMPARATOR
Other: subconjunctival normal saline

1

EXPERIMENTAL
Drug: Avastin

Interventions

subconjunctival normal salineOTHER

0.1cc normal saline injection in the subconjunctival space repeated twice at monthly intervals

2
AvastinDRUG

intravitreal injection of avastin 2.5mg repeated twice at monthly intervals

1

Eligibility Criteria

Age10 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of NVG
  • Vision less than 20/200
  • age 10-80 years

You may not qualify if:

  • Uncontrolled Blood Pressure
  • History of thromboembolism
  • Congestive Heart Failure
  • Renal Failure
  • Pregnancy or Lactation
  • Active ocular or periocular infection
  • No light perception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Labbafinejad Medical Center

Tehran, Tehran Province, 16666, Iran

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Shahin Yazdani, MD

    Ophthalmic Research Center, Shaheed Beheshti Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 4, 2006

First Posted

October 6, 2006

Study Start

April 1, 2006

Study Completion

March 1, 2007

Last Updated

February 15, 2008

Record last verified: 2008-02

Locations

IR(1)