Intravitreal Bevacizumab for Management of Active Progres... | NCT00370721

Studies
Intravitreal Bevacizumab for Management of Active Progressive Proliferative Diabetic Retinopathy (PDR)

NCT00370721

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Unknown status

Last Update Posted

Jun 26, 2008Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Diabetic Retinopathy

Interventions

bevacizumab

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

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

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

Sep 1, 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 evaluate the effect of intravitreal bevacizumab on the course of diabetic retinopathy in cases with the signs of active progressive PDR

Detailed Description

Not provided

Conditions Module

Conditions

Diabetic Retinopathy

Keywords

Proliferative diabetic retinopathy(PDR)
Pan retinal photocoagulation (PRP)
Vitreous hemorrhage
Traction retinal detachment
Neovascularization on disc (NVD)
Neovascularization elsewhere (NVE)
Fibrous proliferation on disc (FPD)
Fibrous proliferaiton elsewhere (FPE)

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

Label	Type	Description	Intervention Names
I	Experimental		Drug: bevacizumab

Name	Type	Description	Arm Group Labels	Other Names
bevacizumab	Drug		I

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Regression of diabetic retinopathy
visual acuity

Secondary Outcomes

Measure	Description	Time Frame
neovascularization
fibrous proliferation
traction retinal detachment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cases of active progressive PDR with history of scatter laser photocoagulation

Exclusion Criteria:

history of vitrectomy

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

Name	Role	Phone	Extension	Email
Hamid Ahmadieh, MD	Contact	+98 21 22585952		hahmadieh@hotmail.com

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	Recruiting	Tehran	Tehran Province	16666	Iran

Condition Browse Module

MeSH Terms

ID	Term
D003930	Diabetic Retinopathy
D014823	Vitreous Hemorrhage

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D003925	Diabetic Angiopathies
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068258	Bevacizumab

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided