Back to resultsIntravitreal Bevacizumab vs. Bevacizumab Combined With Triamcinolone for Neovascular AMD
Primary Purpose
Neovascular Age-Related Macular Degeneration
Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
bevacizumab
bevacizumab + triamcinolone acetonide
Sponsored by
About this trial
This is an interventional treatment trial for Neovascular Age-Related Macular Degeneration focused on measuring Bevacizumab,, Triamcinolone, Age-related macular degeneration, Choroidal neovascular membrane
Eligibility Criteria
Inclusion Criteria: Cases of active neovascular AMD with visual acuity of 20/400- 20/40 Exclusion Criteria: History of glaucoma or ocular hypertension Disciform scar
Sites / Locations
- Hamid Ahmadieh, MD
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Injection of intravitreal bevacizumab
Injection of bevacizumab + triamcinolone acetonide
Outcomes
Primary Outcome Measures
visual acuity
Secondary Outcome Measures
central macular thickness
leakage in fluorescein angiography
intraocular pressure
anterior chamber reaction
Full Information
NCT ID
NCT00370370
First Posted
August 30, 2006
Last Updated
June 25, 2008
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00370370
Brief Title
Intravitreal Bevacizumab vs. Bevacizumab Combined With Triamcinolone for Neovascular AMD
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
5. Study Description
Brief Summary
To compare the efficacy and safety results of intravitreal bevacizumab alone with bevacizumab + triamcinolone acetonide in neovascular AMD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-Related Macular Degeneration
Keywords
Bevacizumab,, Triamcinolone, Age-related macular degeneration, Choroidal neovascular membrane
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Injection of intravitreal bevacizumab
Arm Title
2
Arm Type
Active Comparator
Arm Description
Injection of bevacizumab + triamcinolone acetonide
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Intervention Description
Injection of intravitreal bevacizumab
Intervention Type
Drug
Intervention Name(s)
bevacizumab + triamcinolone acetonide
Intervention Description
Injection of bevacizumab + triamcinolone acetonide
Primary Outcome Measure Information:
Title
visual acuity
Secondary Outcome Measure Information:
Title
central macular thickness
Title
leakage in fluorescein angiography
Title
intraocular pressure
Title
anterior chamber reaction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cases of active neovascular AMD with visual acuity of 20/400- 20/40
Exclusion Criteria:
History of glaucoma or ocular hypertension
Disciform scar
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamid Ahmadieh, MD
Organizational Affiliation
Ophthalmic Research Center of Shaheed Beheshti Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamid Ahmadieh, MD
City
Tehran
ZIP/Postal Code
16666
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Intravitreal Bevacizumab vs. Bevacizumab Combined With Triamcinolone for Neovascular AMD
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