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C. Simader, M. Bolz, M. Ritter, I. Golbaz, C. Ahlers, U. Schmidt-Erfurth; Comparison of Treatment Effects of Ranibizumab on Visual Acuity, Retinal Thickness and Retinal Morphology When Administered Monthly vs. Quaterly With Different Dosing Regimens in the Excite Trial. Invest. Ophthalmol. Vis. Sci. 2009;50(13):3094.
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The effectiveness of regularly administered ranibizumab both on retinal function and retinal morphology has already been proven in many multi-center trials. The positive effect of treatment initiation with a loading phase of 3 monthly doses has already been reported. In this phase IIIb multi-center, randomized, active-controlled, double-masked "Excite" trial, after the loading phase of 3 monthly doses, the treatment effects were compared when ranibizumab was administered monthly versus quarterly with 0.3mg and 0.5 mg.
353 patients at 54 study sites with diagnosis of subfoveal CNV due to AMD were included. Best-corrected visual acuity (BCVA) inclusion criterion was between 20/40 and 20/320. Patients were randomized 1:1:1 to receive 3 initial monthly injections of ranibizumab followed by quarterly injections of 0.3mg in group A, quarterly injections of 0.5mg in group B, and monthly injections of 0.3mg in group C. Change of BCVA letters score, mean central retinal thickness (CRT) in microns (µm) measured with optical coherence tomography (OCT) and appearance of cysts were monthly examined for all patients in all groups.
All groups (120 versus 118 versus 115 patients in groups A,B and C) were balanced regarding age (75.0 to 75.8 years), gender, BCVA (55.8 to 56.5 letters), CRT (314 to 325 µm), lesion type and mean area of lesion (8.3 to 9.75 mm²) and CNV (8.13 to 9.46 mm²). At month 3 in all groups an equally statistically significant increase in BCVA (6.8, 6.6, 7.5 letters) occurred, as well as a statistically significant decrease in CRT (-101, -118, -96 µm) and decrease in appearance of intraretinal cysts. At months 6,9 and 12, one month after all groups were treated with ranibizumab, all groups presented similar CRT values, whereas at months 4, 5, 7, 8, 10 and 11, one month after ranibizumab was only administered in group C, statistically significant higher CRT values were observed in group A and B compared to group C. A higher increase in BCVA compared to baseline was shown at month 12 for group C (+8.3 letters compared to +4.9 and +3.8 in groups A and B, respectively). BCVA, CRT and appearance of cysts showed a high correlation for all visits (p<0.0001). The CRT values at month 12 were -96.0, -105.6, and -105.3 µm, in groups A, B, C respectively.
Monthly and quarterly administration of ranibizumab beyond the loading phase leads to similar CRT outcomes at month 12. An increase in the CRT values during the intervals between quarterly administration may explain the poorer functional outcome at month 12.
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