NCT01330524

Brief Summary

In this study 16 Patients diagnosed with Nonarteritic Anterior Ischemic Optic Neuropathy(NSION) who had a sudden mono ocular vision loss associated with optic disc edema and positive Marcus Gunn in less than 30 days without exclusion criteria are randomly divided in two groups 1) control 2) case. In case group Avastin and Triamcinolone will be injected trough vitreal and placebo will be injected in control group. BCVA and Visual field will be then measured in these two groups.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 7, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

April 7, 2011

Status Verified

November 1, 2009

Enrollment Period

10 months

First QC Date

March 8, 2011

Last Update Submit

April 5, 2011

Conditions

Acute Nonarteritic Anterior Ischemic Optic Neuropathy

Outcome Measures

Primary Outcomes (1)

  • Changes of Best corrected visual acuity(BCVA)

    outcome method of measurement: Snellen chart

    6 month

Secondary Outcomes (1)

  • Changes of Visual Field

    6 month

Study Arms (2)

Avastin and Triamcinolone

ACTIVE COMPARATOR
Drug: Avastin and Triamcinolone

Placebo

PLACEBO COMPARATOR
Other: placebo

Interventions

Avastin and TriamcinoloneDRUG

1.25 mg Avastin and 2mg Triamcinolone will be injected trough vitreal

Avastin and Triamcinolone
placeboOTHER

2mg placebo

Placebo

Eligibility Criteria

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

You may qualify if:

  • Sudden mono ocular vision loss associated with optic disc edema and positive Marcus Gunn (\<30 days)

You may not qualify if:

  • Any eye disease except NAION(Nonarteritic Anterior Ischemic Optic Neuropathy)
  • Neurologic defect
  • Abnormal ESR, CRP, any history of retina or vitreal surgery
  • Severe corneal opacity which makes retina examination impossible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Labbafinejad medical center

Tehran, Iran

RECRUITING

MeSH Terms

Interventions

BevacizumabTriamcinolone

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 8, 2011

First Posted

April 7, 2011

Study Start

January 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2011

Last Updated

April 7, 2011

Record last verified: 2009-11

Locations

IR(1)