Neovascular Age-Related Macular Degeneration Clinical Trial
Official title:
A Randomized, Controlled, Open Label, Phase II Study of Visudyne® Photodynamic Therapy (PDT) Combined With Bevacizumab (Avastin) vs Avastin Alone in Patients With Neovascular Age-Related Macular Degeneration (AMD)
This phase II study was designed to evaluate the safety, tolerability, and efficacy of
bevacizumab treatment in conjunction with PDT at the low fluence rate compared with
bevacizumab alone or combined with PDT at the standard fluence rate, in patients with all
types of choroidal neovascularization secondary to AMD.
Hypothesis: bevacizumab in combination with PDT (low and standard fluence rate) will i)
delay time to retreatment, ii) reduce the average number of treatments required compared to
bevacizumab alone and iii) at low PDT fluence rate will improve long-term safety profile.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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