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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2009 by Shahid Beheshti University of Medical Sciences.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Shahid Beheshti University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT00999791

First received: July 7, 2009

Last updated: May 3, 2010

Last verified: October 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

July 7, 2009

Last Updated Date

May 3, 2010

Start Date ^ICMJE

July 2009

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00999791 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Intervention Model: Parallel Assignment
Primary Purpose: Treatment

Condition ^ICMJE

Diffuse Diabetic Macular Edema

Intervention ^ICMJE

Drug: Bevacizumab
Drug: Diclofenac

Study Arm (s)

Active Comparator: Avastin
Intervention: Drug: Bevacizumab
Active Comparator: Diclofenac
Intervention: Drug: Diclofenac

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Child, Adult, Senior

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact: Masoud Soheilian, MD

+982122585952

labbafi@hotmail.com

Listed Location Countries ^ICMJE

Iran, Islamic Republic of

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00999791

Other Study ID Numbers ^ICMJE

8818

Has Data Monitoring Committee

Yes

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Shahid Beheshti University of Medical Sciences

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Shahid Beheshti University of Medical Sciences

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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