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

Tracking Information
First Submitted Date ICMJE	July 7, 2009
First Posted Date ICMJE	October 22, 2009
Last Update Posted Date	May 4, 2010
Study 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. 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.
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 Arms	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	Unknown status
Enrollment ICMJE	Not Provided
Original Enrollment ICMJE	Not Provided
Study 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
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Senior
Accepts Healthy Volunteers	Not Provided
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
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
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Shahid Beheshti University of Medical Sciences
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	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