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P. G. Massin, Y. Hashad, G. Burian, A. Weichselberger; Evaluation of the Re-Treatment Criteria Effectiveness in the RESOLVE Study. Invest. Ophthalmol. Vis. Sci. 2010;51(13):4253.
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RESOLVE demonstrated the overall efficacy of ranibizumab in diabetic macular edema (DME). In the present analysis, VA and CRT responses after dose interruption and re-initiation were assessed in ranibizumab-treated DME patients (pts) of RESOLVE in order to evaluate the concept of treatment (tx) interruption/re-initiation criteria based on disease stability/activity status.
In the 12-mo RESOLVE study, 102 pts were monitored monthly and treated with ranibizumab (6 and 10mg/ml) with 3 initial consecutive monthly injections and then as needed based on pre-defined VA/CRT-guided re-tx criteria based on tx success and futility. To evaluate the concepts of disease stability/activity, a VA change of 3 letters or a CRT change of 50µm over the last 3 consecutive visits (incl current visit) were taken as cutoff values.
Evaluation of tx response based on disease stability: 84% and 74% of the ranibizumab-treated RESOLVE pts fulfilled the VA and VA+CRT stability criteria, respectively. One month after tx upon detecting disease stability, the mean (±SE) change in VA/CRT was for the VA criterion +1.1±0.7 letters (n=72)/-2.8±4.1 µm (n=69) and for the VA+CRT criterion +0.1±0.6 letters (n=60)/-8.0±4.0 µm (n=58), suggesting no clinically significant improvement when the disease is stable and supporting this tx interruption criteria.Evaluation of tx response based on disease activity: of the total 50 re-initiation injections between Months 3 and 11, 42% (n=21) and 64% (n=32) fulfilled VA, and VA or CRT disease activity criteria, respectively. One month after tx re-initiation, the mean (±SE) change in VA/CRT was for the VA criterion +10.0±1.3 letter (n=20)/-133±25.9 µm (n=20) and for the VA or CRT criteria +6.0±1.38 letters (n=31)/-123.8±17.3 µm (n=31), suggesting a clinically relevant VA outcome when disease activity is observed and supporting these re-initiation criteria.
Overall, the analysis suggests that tx interruption and re-initiation based on disease stability and activity criteria derived from monthly VA and CRT assessments is a viable concept to provide guidance for individualized tx in DME pts with visual impairment.
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