Intravitreal Diclofenac Versus Avastin as Primary Treatme... | NCT00999791

Studies
Intravitreal Diclofenac Versus Avastin as Primary Treatment of Diffuse Diabetic Macular Edema

NCT00999791

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Unknown status

Last Update Posted

May 4, 2010Estimated

Enrollment

Not provided

Phase

Phase 1

Conditions

Diffuse Diabetic Macular Edema

Interventions

Bevacizumab
Diclofenac

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

Oct 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

Jul 2009

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 7, 2009

First Submission Date that Met QC Criteria

Oct 21, 2009

First Posted Date

Oct 22, 2009Estimated

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

May 3, 2010

Last Update Posted Date

May 4, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Diffuse Macular Edema is the main cause of visual disorders in diabetic patients.

Diclofenac is a cheap drug available in most of treatment centers.in animal studies the safe dosage is identified that can be used in diffuse diabetic macular edema for treatment. in this study, we are going to compare the effect of intra vitreal injection of Diclofenac and Bevacizumab in primary treatment of diffuse diabetic macular edema.

Detailed Description

Diffuse Macular Edema is the main cause of visual disorders in diabetic patients.

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 1

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Label	Type	Description	Intervention Names
Avastin	Active Comparator		Drug: Bevacizumab
Diclofenac	Active Comparator		Drug: Diclofenac

Name	Type	Description	Arm Group Labels	Other Names
Bevacizumab	Drug		Avastin
Diclofenac

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with clinically significant macular edema and diffuse macular edema

Exclusion Criteria:

any history of focal photocoagulation
any prior intra ocular injection
history of glaucoma with high pressure
history of ophthalmic surgery
high rish PDR
active PDR

Accepts Healthy Volunteers

Not provided

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
Masoud Soheilian, MD	Contact	+982122585952		labbafi@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ophthalmic Research Center	Recruiting	Tehran	Tehran Province	166666	Iran

Intervention Browse Module

MeSH Terms

ID	Term
D000068258	Bevacizumab
D004008	Diclofenac

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

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