Purpose:
To compare treatment with intravitreal ranibizumab (IVR) alone with combination treatment using IVR plus verteporfin photodynamic therapy (PDT) in neovascular age-related macular degeneration (NAMD)
Methods:
Thirty-nine eyes with NAMD were randomized to each group. The monotherapy IVR group received injections every 4 weeks for 6 consecutive injections, then PRN. The combination (IVR+PDT) group received one IVR injection 7 days after verteporfin PDT (83 seconds at 300 mW/cm2, 25J/cm2), then PRN. Eyes were evaluated with ETDRS best-corrected visual acuity (V/A), fluorescein angiography (FA), and optical coherence tomography (OCT), at baseline, weeks 1, 3 and 5, then every 4 weeks. The main outcome measures were V/A and number of treatments. Secondary outcome measures were closure of choroidal neovascularization (CNV) on FA (C) and changes in mean lesion thickness and volume on OCT.
Results:
The table summarizes outcomes for both treatment groups after a mean follow-up of 6 months. The number of treatments (P<0.0001) and C(P<0.005) were statistically significant. The C difference was more pronounced in the subgroup analysis of the IVR group. Eyes that had poor early closure (C<50%) lost vision after the 2nd and 3rd injections (mean of 5 letters), whereas eyes that had progressively better early closure (C>50%) gained vision (mean 23 letters). No systemic or ocular side-effects were noted.
Conclusions:
In this prospective case series, IVR and combination IVR+PDT therapies were safe and effective in the treatment of NAMD. Combination treatment was more efficient in reducing the number of treatments required. C analysis on FA provides an early prognostic indication to predict eyes that may not respond to IVR treatment alone.
Clinical Trial:
www.clinicaltrials.gov NCT00570193 Pending
Keywords: photodynamic therapy • age-related macular degeneration