Aim: To determine if reduced light dose photodynamic therapy (PDT) combined with bevacizumab will decrease the number of bevacizumab treatments required over six months compared to 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 three-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 six months.
Results: Patients required a mean of 2.8 bevacizumab treatments in group 1 and 2.5 in group 2, compared to 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 six 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.
This clinical trial was registered on ClinicalTrials.gov, Identifier NCT00359164.