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Effect of Intravitreal Bevacizumab on Clinically Significant 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. Identifier: NCT00370669
Recruitment Status : Unknown
Verified February 2007 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : September 1, 2006
Last Update Posted : February 22, 2007
Information provided by:
Shahid Beheshti University of Medical Sciences

Brief Summary:
to compare the effect of intravitreal bevacizumab alone or in combination with triamcinolone acetonide with laser photocoagulation on clinically significant macular edema (CSME)

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: bevacizumab Drug: triamcinolone acetonide Phase 3

Detailed Description:
we entered 150 eyes into the study that recruitment of cases finished recently.Eligible eyes randomly assign to one of the study arms including intravitreal bevacizumzb, intravitreal bevacizumzb/triamcinolone and macular photocoagulation groups. Every patient needs at least 1 year followup. During this time BCVA, OCT, FA will be done for each patient and inaccording to interpretation of datas and fundus exam repeatation of injection will be done.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Study Start Date : November 2005
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Bevacizumab

Primary Outcome Measures :
  1. visual acuity
  2. central macular thickness

Secondary Outcome Measures :
  1. Leakage in fluorescein angiography
  2. intraocular pressure
  3. cataract progression
  4. anterior chamber reaction

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • case with clear media IOP below 23 mm/Hg female after menopause at least for 12 months or had 2 contraceptive roots visual acuity between 20/50 to 20/320

Exclusion Criteria:

  • no PRP or N.d YAG laser in past 6 months no intraocular surgery in past 12 months
  • CVA in past 12 months blood sugar above 250
  • active infection in extraocular adnexa

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 identifier (NCT number): NCT00370669

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Contact: Masoud Soheilian, MD +98 21 22585952

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Iran, Islamic Republic of
Masoud Soheilian Recruiting
Tehran, Iran, Islamic Republic of, 16666
Contact: Masoud Soheilian, MD    +98 21 22585952   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
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Principal Investigator: Masoud Soheilian Ophthalmic Research Center of Shaheed Beheshti Medical University
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00370669    
Other Study ID Numbers: 8411
First Posted: September 1, 2006    Key Record Dates
Last Update Posted: February 22, 2007
Last Verified: February 2007
Keywords provided by Shahid Beheshti University of Medical Sciences:
Triamcinolone acetonide
Additional relevant MeSH terms:
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Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action