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Sebastian Waldstein, Ulrike Mayr-Sponer, Markus Ritter, Michael Kundi, Christian Simader, Ursula Schmidt-Erfurth, Vienna Reading Center; Impact of the vitreous configuration on the efficacy of quarterly, pro-re-nata and monthly treatment in multicenter trials evaluating ranibizumab for neovascular age-related macular degeneration. Invest. Ophthalmol. Vis. Sci. 2013;54(15):3818.
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Intravitreal administration of antiangiogenic drugs is the mainstay of current treatment of exudative macular diseases. However, the impact of the vitreous on the relevant pharmacokinetic mechanisms is unclear. The purpose of this study was to investigate the influence of the configuration of the vitreomacular interface (VMI) on the efficacy of quarterly, pro re nata (PRN) and monthly dosing of ranibizumab in the treatment of neovascular age-related macular degeneration (AMD).
Standardized monthly optical coherence tomography (OCT) examinations of 486 treatment-naïve patients, enrolled in two separate 12-month prospective randomized multicenter trials, were analyzed for the configuration of the VMI by certified graders of the Vienna Reading Center. Only patients with 10 or more available OCT-examinations, including baseline and month 12, were eligible for the analysis. The individual VMI readings from each visit were integrated to divide all patients into one of the following categories: (1) persistent vitreomacular adhesion (VMA); (2) progressive release of vitreomacular adhesion (RVA); (3) complete posterior vitreous detachment (PVD).
At month 12, the mean change in best-corrected visual acuity (BCVA) from baseline was as follows: Quarterly treatment (n=163): VMA -0.3, RVA +3.2, PVD +4.7 letters; PRN treatment (n=128): VMA +6.3, RVA +4.3, PVD +3.7 letters; monthly treatment (n=84): VMA +7.5, RVA +12.7, PVD +4.9 letters. Quarterly treatment was non-inferior to monthly treatment in patients with PVD, p=0.001. Monthly treatment was superior to quarterly treatment in patients with VMA and RVA, p=0.035. In the PRN regimen, patients with PVD required significantly less dosing (mean 4.8 injections) compared to VMA and RVA (mean 5.3/6.6 injections, p<0.001). The functional outcomes of monthly treatment of patients with VMA and RVA surpassed those of all others.
The configuration of the VMI has a significant impact on the efficacy of therapeutic regimens. Patients with PVD appear to be less sensitive to dosing variations, while patients with VMA and RVA may derive optimal benefit from continuous intensive treatment. Our findings may serve as a base for individualized treatment decisions in neovascular AMD and potentially other indications.
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