The purpose of this study is to determine the association of bevacizumab and PDT is safety and effective in the treatment of exudative AMD
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 endophthalmites. The participants of this study will be randomized in 1:1 ration to one of the two study groups: single therapy of bevacizumab (3 injections in 3 months) or association of bevacizumab (3 injections in 3 months) and full fluence of PDT (single at the baseline). All bevacizumab injection will contain 1.25g of the drug and will be administrate every month for 3 continuos months. After randomization, participants will return to the clinic approximately every four weeks for 4 months for study assessments and possible re-treatment (if is necessary). Participants will return to the clinic at week 20 for a final study assessment. Study assessments include: visual acuity, optical coherence tomography and fundus photography.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
1.25 mg of bevacizumab intravitreal
full fluence of vetaporfin
UNIFESP
São Paulo, São Paulo, Brazil
RECRUITINGThe mean change in best-corrected ETDRS visual acuity in the study eye from baseline to 4 months
Time frame: 4
The overall probability of re-injection
Time frame: 4
Proportion of participants with reduction in retinal thickening in the center subfield (i.e., thickness > 200 microns) of ³50% and of at least 50 microns from baseline
Time frame: 4
Mean change in area of leakage, CNV and lesion by the FA and ICG
Time frame: 4
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