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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Department of Ophthalmology, University of Padova
Padua, PD, Italy
Number of Bevacizumab injections
Time frame: One year
The mean change in best-corrected ETDRS visual acuity in the study eye
Time frame: Months 6 and 12
Mean change in total CNV area (Disc Areas)
Time frame: Months 6 and 12
Changes of central retinal thickness measured by Optical Coherence Tomography (OCT).
Time frame: Months 6 and 12
NEI VFQ-25 (vision-related quality of life) score
Time frame: One year
Pelli-Robson Contrast Sensitivity Score
Time frame: One year
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