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Ali Erginay, Rabih Hage, Mohamed El Sanharawi, Bénédicte Dupas, Julie Jacob, Pascale Massin; Evaluation of the efficacy of ranibizumab for the treatment of diabetic macular edema in daily practice. Invest. Ophthalmol. Vis. Sci. 2014;55(13):3903.
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© ARVO (1962-2015); The Authors (2016-present)
The efficacy of ranibizumab (RNB) for diabetic macular edema (DME) has been demonstrated by several randomized studies. They showed that monthly injections of RNB were needed to improve visual acuity (VA) during the first year of treatment. This treatment has been available in France for DME for 2 years. The objective of this study was to assess retrospectively the results of RNB treatment for DME in “real-life”, and compare them with those observed in the pivotal studies.
In this retrospective study, the records of diabetic patients treated by RNB for DME and followed for at least 6 months were reviewed. All the eyes were treated by monthly RNB injections until stable visual acuity was reached, and then on the basis of a Pro Re Nata (PRN) regimen. The gain of VA ETDRS score at 3,6,12 and 18 months, the maximal visual gain, the evolution of macular thickness, the average number of injections and visits for each patient were recorded.
The data of 112 eyes of 85 diabetic patients (mean age: 60 ± 10 years) was reviewed. After an average follow-up of 13.2±8.5 months, the gain of VA was 8.3±10 letters and the decrease of macular thickness was 170±153μm. The average number of intravitreal injections was 7.3±3.5. The average number of visits was 8.7±3. The maximal visual gain (13.5±9.8 letters) was obtained after an average delay of 6.5±4 months and average number of 4.8±2.5 injections. The average number of injections decreased with time: 4.54 during the first 6 months, 2.3 during the next 6 months, and 2 between 12 and 18 months. An improvement of 3 lines or more in visual acuity was obtained in 24.1 % of eyes. The gain in visual acuity at 3 months was highly predictive of the maximal visual acuity gain (R2=0.653, p<0.001). A total absence of clinical and anatomical response at 3 months was observed in 12/112 eyes (10.7 %). No major side effect was observed.
This retrospective study showed that the efficacy of RNB to treat DME was similar to that observed in the pivotal studies.These data confirm that an intensive treatment during the first months is necessary to obtain a maximal visual gain and that the initial answer at 3 months in term of visual acuity is predictive of the long term outcome .
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