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B. C. Braun, U. Schneider, B. Henrich, K. Hatz, G. Fuchsjäger-Mayrl, C. Pruente; Evaluation of Re-Treatment Indications in a Randomized, Double-masked, Phase IIIb-Study Comparing Lucentis® Monotherapy versus PDT Combined With Lucentis® in Patients With Subfoveal Choroidal Neovascularisation. Invest. Ophthalmol. Vis. Sci. 2008;49(13):1172.
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The aim of this study was to evaluate re-treatment frequency and indications in a randomized controlled trial comparing Lucentis (Ranibizumab) monotherapy and combination therapy using standard fluence PDT and Lucentis.
Patients were randomized to receive initial PDT or sham PDT, followed by 3 initial monthly 0.3mg intravitreal Lucentis injections. Thereafter, patients received Lucentis injections, if at a monthly visit a loss of more than 5 ETDRS letters in BCVA or an increase in central retinal thickness (CRT) >100µm (OCT) were observed.
40 patients were recruited, 37 patients reached primary endpoint at 6 months (19 in the monotherapy and 18 in the combination group). Both groups showed well balanced baseline characteristics. Mean BCVA significantly increased by 11.8 letters in the monotherapy and 7.8 letters in the combination group after 6 months. 29.7% of all patients (n=11, with a total of 13 re-injections) needed re-treatment during first 6 months, 42.1% in the monotherapy (n=8) and 16.7% in the combination arm (n=3).A significant difference (p<0.05) was found for the need of re-treatment at 6 months with a total of 10 re-treatments in the monotherapy and 3 re-treatments in the combination group. Mean treatment free interval before first re-injection during 6 months was 2.64 months and 2.63 months respectively. Two monotherapy patients needed 2 re-injections; all other patients only 1 re-injection. In 46.2% indication for re-treatment was a loss of more than 5 ETDRS letters and in 53.8% increased CRT of more than 100 µm. There was no significant difference between the groups with regard to re-treatment indications.
These results demonstrate that a significant initial visual gain after Lucentis treatment can be maintained by PRN treatment with only 29.7% of patients needing re-treatment during the first 6 months. Although the BCVA outcome of Lucentis monotherapy shows a non-significant trend to be more favorable, the need for re-injection is significantly lower in the combination arm. However, the optimal strategy for follow-up of these patients after the first three injections has still to be established and therefore further investigations are suggested.
Clinical Trial: :
www.clinicaltrials.gov NCT 00429962
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