Macular Degeneration Clinical Trial
Official title:
Intravitreal Bevacizumab Combined With PDT (Full Fluence) Versus Bevacizumab to Treat Exudative Age-Related Macular Degeneration
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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