Back to resultsCombined PDT and Intravitreal Bevacizumab vs Combination of PDT, Intravitreal Bevacizumab and 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
verteporfin, bevacizumab, triamcinolone acetonide
Sponsored by
About this trial
This is an interventional treatment trial for Neovascular Age-Related Macular Degeneration focused on measuring Photodynamic therapy,, 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, MDRecruiting
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
NCT00370539
First Posted
August 30, 2006
Last Updated
November 13, 2006
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00370539
Brief Title
Combined PDT and Intravitreal Bevacizumab vs Combination of PDT, Intravitreal Bevacizumab and Triamcinolone for Neovascular AMD
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Unknown status
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (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 of photodynamic therapy (PDT) combined with intravitreal bevacizumab versus combination of photodynamic therapy , intravitreal bevacizumab and intravitreal triamcinolone for 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
Photodynamic therapy,, 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
Single
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
verteporfin, 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hamid Ahmadieh, MD
Phone
+98 21 22585952
Email
hahmadieh@hotmail.com
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hamid Ahmadieh, MD
Phone
+98 21 22585952
Email
hahmadieh@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Combined PDT and Intravitreal Bevacizumab vs Combination of PDT, Intravitreal Bevacizumab and Triamcinolone for Neovascular AMD
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