Status:
UNKNOWN
Intravitreal Bevacizumab Combined With PDT Versus Bevacizumab to Treat Exudative AMD
Lead Sponsor:
Federal University of São Paulo
Conditions:
Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the association of bevacizumab and PDT is safety and effective in the treatment of exudative AMD
Detailed Description
Exudative AMD is the leader of blind in people more than 60 years. The best treatment for this disease today are monthly injections of anti-VEGF in the vitreous cavity which increase the chance to get...
Eligibility Criteria
Inclusion
- more or iqual 50 years old
- male or female
- Choroidal neovascularization sub or just foveal the fovea secondary to AMD (Predominantly Classic, Minimally Classic, and Occult lesions acceptable)
- Greatest linear dimension (GLD) of entire lesion \< 5400 µm (no reading center confirmation required)
- ETDRS best corrected visual acuity of 20/40 - 20/320 (73 - 24 letter score)
- Total area of lesion must \< 9 MPS DA
Exclusion
- pre-treatment
- ETDRS best corrected visual acuity better than 34 letters
- macular surgery history
- laser photocoagulation in the study eye within 30 dais
- eye surgery within 30 days
- history of no-treat glaucoma
- acuite uveits
- history of endophthalmites
- vitreous hemorrhage
- geographic atrophy or fibrosis corresponding \> 50% of the lesion
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00684853
Start Date
November 1 2007
Last Update
May 28 2008
Active Locations (1)
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1
UNIFESP
São Paulo, São Paulo, Brazil, 04023-062