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Effect of Intravitreal Bevacizumab on Clinically Significant Macular Edema

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2007 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00370669
First Posted: September 1, 2006
Last Update Posted: February 22, 2007
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.
Information provided by:
Shahid Beheshti University of Medical Sciences
  Purpose
to compare the effect of intravitreal bevacizumab alone or in combination with triamcinolone acetonide with laser photocoagulation on clinically significant macular edema (CSME)

Condition Intervention Phase
Diabetic Macular Edema Drug: bevacizumab Drug: triamcinolone acetonide Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti University of Medical Sciences:

Primary Outcome Measures:
  • visual acuity
  • central macular thickness

Secondary Outcome Measures:
  • Leakage in fluorescein angiography
  • intraocular pressure
  • cataract progression
  • anterior chamber reaction

Estimated Enrollment: 150
Study Start Date: November 2005
Estimated Study Completion Date: February 2007
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.
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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): NCT00370669


Contacts
Contact: Masoud Soheilian, MD +98 21 22585952 labbafi@hotmail.com

Locations
Iran, Islamic Republic of
Masoud Soheilian Recruiting
Tehran, Iran, Islamic Republic of, 16666
Contact: Masoud Soheilian, MD    +98 21 22585952    labbafi@hotmail.com   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
Principal Investigator: Masoud Soheilian Ophthalmic Research Center of Shaheed Beheshti Medical University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00370669     History of Changes
Other Study ID Numbers: 8411
First Submitted: August 30, 2006
First Posted: September 1, 2006
Last Update Posted: February 22, 2007
Last Verified: February 2007

Keywords provided by Shahid Beheshti University of Medical Sciences:
Bevacizumab
CSME
MPC
Triamcinolone acetonide

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action