Aim To determine if reduced light-dose photodynamic therapy (PDT) combined with bevacizumab will decrease the number of bevacizumab treatments required over 6 months compared with bevacizumab monotherapy in neovascular age-related macular degeneration (AMD).
Methods Thirty-six patients with neovascular AMD were recruited for this randomised, double-masked, controlled clinical trial. Patients received intravitreal bevacizumab plus PDT using a light dose of either 25 J/cm2 (group 1) or 12 J/cm2 (group 2), or intravitreal bevacizumab plus sham PDT (group 3). Patients returned monthly for possible retreatment with bevacizumab or combination therapy (with a 3-month minimum interval between combination treatments); retreatment decisions were primarily based on optical coherence tomography. The main outcome measure was the mean number of bevacizumab treatments required over 6 months.
Results Patients required a mean of 2.8 bevacizumab treatments in group 1 and 2.5 in group 2, compared with 5.1 in group 3 (p = 0.005 and p<0.001, respectively).
Conclusions Combination bevacizumab and 25 J/cm2 or 12 J/cm2 PDT significantly reduced the number of bevacizumab treatments required over 6 months. This study was powered to examine number of treatments, but not visual acuities. Nevertheless, visual acuities responded favourably in all three groups. Further studies will be helpful to explore visual outcomes.
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Funding This study was an investigator-initiated trial sponsored by QLT, Vancouver, Canada. The sponsor of this study had no role in the design; collection, analysis or interpretation of data; manuscript writing; or the decision to submit the manuscript for publication.
Competing interests MJP has received consulting fees from Novartis, and he has received grant support from QLT, Allergan and Regeneron.
Ethics approval Ethics approval was provided by the institutional review boards of the University of British Columbia and the Vancouver Coastal Health Authority.
Patient consent Obtained.
Provenance and peer review Not commissioned; externally peer reviewed.