Back to resultsEffect of Intravitreal Bevacizumab on Clinically Significant Macular Edema
Primary Purpose
Diabetic Macular Edema
Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
bevacizumab
triamcinolone acetonide
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Bevacizumab, CSME, MPC, Triamcinolone acetonide
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
Sites / Locations
- Masoud SoheilianRecruiting
Outcomes
Primary Outcome Measures
visual acuity
central macular thickness
Secondary Outcome Measures
Leakage in fluorescein angiography
intraocular pressure
cataract progression
anterior chamber reaction
Full Information
NCT ID
NCT00370669
First Posted
August 30, 2006
Last Updated
February 21, 2007
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00370669
Brief Title
Effect of Intravitreal Bevacizumab on Clinically Significant Macular Edema
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Unknown status
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Bevacizumab, CSME, MPC, Triamcinolone acetonide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Intervention Type
Drug
Intervention Name(s)
triamcinolone acetonide
Primary Outcome Measure Information:
Title
visual acuity
Title
central macular thickness
Secondary Outcome Measure Information:
Title
Leakage in fluorescein angiography
Title
intraocular pressure
Title
cataract progression
Title
anterior chamber reaction
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Masoud Soheilian, MD
Phone
+98 21 22585952
Email
labbafi@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masoud Soheilian
Organizational Affiliation
Ophthalmic Research Center of Shaheed Beheshti Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Masoud Soheilian
City
Tehran
ZIP/Postal Code
16666
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masoud Soheilian, MD
Phone
+98 21 22585952
Email
labbafi@hotmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
22234244
Citation
Soheilian M, Garfami KH, Ramezani A, Yaseri M, Peyman GA. Two-year results of a randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus laser in diabetic macular edema. Retina. 2012 Feb;32(2):314-21. doi: 10.1097/IAE.0b013e31822f55de.
Results Reference
derived
PubMed Identifier
19376585
Citation
Soheilian M, Ramezani A, Obudi A, Bijanzadeh B, Salehipour M, Yaseri M, Ahmadieh H, Dehghan MH, Azarmina M, Moradian S, Peyman GA. Randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus macular photocoagulation in diabetic macular edema. Ophthalmology. 2009 Jun;116(6):1142-50. doi: 10.1016/j.ophtha.2009.01.011. Epub 2009 Apr 19.
Results Reference
derived
Learn more about this trial
Effect of Intravitreal Bevacizumab on Clinically Significant Macular Edema
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