Comparison of Intravitreal Bevacizumab and Triamcinolone... | NCT01330524

Studies
Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo

NCT01330524

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Unknown status

Last Update Posted

Apr 7, 2011Estimated

Enrollment

16Estimated

Phase

Phase 1Phase 2

Conditions

Acute Nonarteritic Anterior Ischemic Optic Neuropathy

Interventions

Avastin and Triamcinolone
placebo

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Nov 2010Estimated

Completion Date

Nov 2011Estimated

First Submitted Date

Mar 8, 2011

First Submission Date that Met QC Criteria

Apr 5, 2011

First Posted Date

Apr 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2011

Last Update Posted Date

Apr 7, 2011Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Avastin and Triamcinolone	Active Comparator		Drug: Avastin and Triamcinolone
Placebo	Placebo Comparator		Other: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Avastin and Triamcinolone	Drug	1.25 mg Avastin and 2mg Triamcinolone will be injected trough vitreal	Avastin and Triamcinolone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes of Best corrected visual acuity(BCVA)	outcome method of measurement: Snellen chart	6 month

Secondary Outcomes

Measure	Description	Time Frame
Changes of Visual Field	Automated perimeter	6 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

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

Exclusion criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Labbafinejad medical center	Recruiting	Tehran			Iran

Intervention Browse Module

MeSH Terms

ID	Term
D000068258	Bevacizumab
D014221	Triamcinolone

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided