Intravitreal Bevacizumab vs. Bevacizumab Combined With Tr... | NCT00370370

Studies
Intravitreal Bevacizumab vs. Bevacizumab Combined With Triamcinolone for Neovascular AMD

NCT00370370

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Unknown status

Last Update Posted

Jun 26, 2008Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Neovascular Age-Related Macular Degeneration

Interventions

bevacizumab
bevacizumab + triamcinolone acetonide

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

Jun 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 30, 2006

First Submission Date that Met QC Criteria

Aug 30, 2006

First Posted Date

Aug 31, 2006Estimated

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

Jun 25, 2008

Last Update Posted Date

Jun 26, 2008Estimated

Description Module

Brief Summary

To compare the efficacy and safety results of intravitreal bevacizumab alone with bevacizumab + triamcinolone acetonide in neovascular AMD.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Injection of intravitreal bevacizumab	Drug: bevacizumab
2	Active Comparator	Injection of bevacizumab + triamcinolone acetonide	Drug: bevacizumab + triamcinolone acetonide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bevacizumab	Drug	Injection of intravitreal bevacizumab	1
bevacizumab + triamcinolone acetonide

Measure	Description	Time Frame
visual acuity

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cases of active neovascular AMD with visual acuity of 20/400- 20/40

Exclusion Criteria:

History of glaucoma or ocular hypertension
Disciform scar

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hamid Ahmadieh, MD	Ophthalmic Research Center of Shaheed Beheshti Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hamid Ahmadieh, MD		Tehran	Tehran Province	16666	Iran

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068258	Bevacizumab
D014222	Triamcinolone Acetonide

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
central macular thickness
leakage in fluorescein angiography
intraocular pressure