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Clinical Trials/NCT00370669
NCT00370669
Unknown
Phase 3

Effect of Intravitreal Bevacizumab on Clinically Significant Macular Edema

Shahid Beheshti University of Medical Sciences1 site in 1 country150 target enrollmentNovember 2005

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Diabetic Macular Edema
Sponsor
Shahid Beheshti University of Medical Sciences
Enrollment
150
Locations
1
Primary Endpoint
visual acuity
Last Updated
19 years ago

Overview

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)

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.

Registry
clinicaltrials.gov
Start Date
November 2005
End Date
February 2007
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

visual acuity

central macular thickness

Secondary Outcomes

  • Leakage in fluorescein angiography
  • intraocular pressure
  • cataract progression
  • anterior chamber reaction

Study Sites (1)

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