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 Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00999791
First received: July 7, 2009
Last updated: May 3, 2010
Last verified: October 2009
  Purpose

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 Intervention Phase
Diffuse Diabetic Macular Edema
Drug: Bevacizumab
Drug: Diclofenac
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Treatment

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Further study details as provided by Shahid Beheshti Medical University:

Study Start Date: July 2009
Arms Assigned Interventions
Active Comparator: Avastin Drug: Bevacizumab
Active Comparator: Diclofenac Drug: Diclofenac

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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999791

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

Locations
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 Medical University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00999791     History of Changes
Other Study ID Numbers: 8818
Study First Received: July 7, 2009
Last Updated: May 3, 2010
Health Authority: Iran: Ethics Committee

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diclofenac
Bevacizumab
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 23, 2014