Effect of Intravitreal Bevacizumab on Clinically Significant Macular Edema

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Shahid Beheshti Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00370669
First received: August 30, 2006
Last updated: February 21, 2007
Last verified: February 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti Medical University:

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

Genders Eligible for Study:   Both
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
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: 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 Medical University
Investigators
Principal Investigator: Masoud Soheilian Ophthalmic Research Center of Shaheed Beheshti Medical University
  More Information

No publications provided by Shahid Beheshti Medical University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00370669     History of Changes
Other Study ID Numbers: 8411
Study First Received: August 30, 2006
Last Updated: February 21, 2007
Health Authority: Iran: Ethics Committee

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

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

ClinicalTrials.gov processed this record on July 24, 2014