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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00999791
Recruitment Status : Unknown
Verified October 2009 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : October 22, 2009
Last Update Posted : May 4, 2010
Sponsor:
Information provided by:
Shahid Beheshti University of Medical Sciences

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.


Condition or disease Intervention/treatment Phase
Diffuse Diabetic Macular Edema Drug: Bevacizumab Drug: Diclofenac Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Study Start Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Active Comparator: Avastin Drug: Bevacizumab
Active Comparator: Diclofenac Drug: Diclofenac




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00999791


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

Locations
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Iran, Islamic Republic of
Ophthalmic Research Center Recruiting
Tehran, Iran, Islamic Republic of, 166666
Contact: Masoud Soheilian, MD    +98 21 22585952    labbafi@hotmail.com   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
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ClinicalTrials.gov Identifier: NCT00999791    
Other Study ID Numbers: 8818
First Posted: October 22, 2009    Key Record Dates
Last Update Posted: May 4, 2010
Last Verified: October 2009
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diclofenac
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action