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In order to prevent central nervous system ( CNS ) involvement and improve the prognosis of primary intraocular lymphoma ( PIOL ), we prospectively evaluated the efficacy of combined therapy using intravitreal methotrexate ( MTX ) and systemic high‐dose  MTX  on treatment‐naïve  PIOL . Patients with newly diagnosed  PIOL  whose lymphoma was limited to the eyes were enrolled. The patients were treated with weekly intravitreal  MTX  until the ocular lesions were resolved, followed by five cycles of systemic high‐dose  MTX  (3.5 g/m 2 ) every other week. Ten patients were enrolled in this study and completed the treatment. All patients achieved complete response for their ocular lesions with rapid decrease of intravitreal interleukin‐10 concentration. Adverse events of intravitreal and systemic high‐dose  MTX  were mild and tolerable. With a median follow‐up of 29.5 months, four patients (40%) experienced the  CNS  disease development and the mean  CNS  lymphoma‐free survival ( CLFS ) time was 51.1 months. Two‐year  CLFS , which was the primary end‐point of the study, was 58.3% (95% confidence interval, 23.0–82.1%). In contrast, eight patients were treated with intravitreal  MTX  alone in our institute, and their 2‐year  CLFS  was 37.5% (95% confidence interval, 8.7–67.4%). In conclusion, systemic high‐dose  MTX  following intravitreal  MTX  is feasible and might be effective in preventing  CNS  involvement of  PIOL . Further arrangements are worth considering in order to improve the effects. This study was registered with  UMIN  Clinical Trials Registry ( UMIN 3921).

cancer science

High‐dose methotrexate following intravitreal methotrexate administration in preventing central nervous system involvement of primary intraocular lymphoma