Back to resultsIntravitreal Diclofenac Versus Avastin as Primary Treatment of Diffuse Diabetic Macular Edema
Primary Purpose
Diffuse Diabetic Macular Edema
Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Bevacizumab
Diclofenac
Sponsored by
About this trial
This is an interventional treatment trial for Diffuse Diabetic Macular Edema
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
Sites / Locations
- Ophthalmic Research CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Avastin
Diclofenac
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00999791
First Posted
July 7, 2009
Last Updated
May 3, 2010
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00999791
Brief Title
Intravitreal Diclofenac Versus Avastin as Primary Treatment of Diffuse Diabetic Macular Edema
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Diabetic Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
8. Arms, Groups, and Interventions
Arm Title
Avastin
Arm Type
Active Comparator
Arm Title
Diclofenac
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Type
Drug
Intervention Name(s)
Diclofenac
10. Eligibility
Sex
All
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Masoud Soheilian, MD
Phone
+982122585952
Email
labbafi@hotmail.com
Facility Information:
Facility Name
Ophthalmic Research Center
City
Tehran
ZIP/Postal Code
166666
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masoud Soheilian, MD
Phone
+98 21 22585952
Email
labbafi@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Intravitreal Diclofenac Versus Avastin as Primary Treatment of Diffuse Diabetic Macular Edema
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