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N. M. Jabbour, J. V. Odom; Comparison of Treatment Using Intravitreal Ranibizumab Alone With Combination Treatment Using Intravitreal Ranibizumab and Verteporfin Photodynamic Therapy in Neovascular Age-Related Macular Degeneration. Invest. Ophthalmol. Vis. Sci. 2008;49(13):560. doi: https://doi.org/.
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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)
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.
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.
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.
www.clinicaltrials.gov NCT00570193 Pending
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