April 2010
Volume 51, Issue 13
ARVO Annual Meeting Abstract  |   April 2010
Evaluation of the Re-Treatment Criteria Effectiveness in the RESOLVE Study
Author Affiliations & Notes
  • P. G. Massin
    Ophthalmology, Lariboisiere Hospital, Paris, France
  • Y. Hashad
    Novartis Pharma AG, Basel, Switzerland
  • G. Burian
    Novartis Pharma AG, Basel, Switzerland
  • A. Weichselberger
    Novartis Pharma AG, Basel, Switzerland
  • Footnotes
    Commercial Relationships  P.G. Massin, Allergan, C; Novartis Pharma AG, C; Fovea, C; Takeda, C; Eli Lilly, C; Novartis Pharma AG, R; Takeda, R; Y. Hashad, Novartis Pharma AG, E; G. Burian, Novartis Pharma AG, E; A. Weichselberger, Novartis Pharma AG, E.
  • Footnotes
    Support  None.
Investigative Ophthalmology & Visual Science April 2010, Vol.51, 4253. doi:
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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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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose: : 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.

Methods: : 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.

Results: : 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.

Conclusions: : 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.

Clinical Trial: : www.clinicaltrials.gov NCT00284050

Keywords: diabetic retinopathy • vascular endothelial growth factor • visual acuity 

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