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INTRODUCTION: The study aimed to evaluate comparability in terms of efficacy, safety and immunogenicity of Sun's ranibizumab biosimilar with reference ranibizumab in patients with neovascular age-related macular degeneration (nAMD). METHODS: This prospective, randomised, double-blind, two-group, parallel-arm, multicentre, phase 3 comparative study included patients with nAMD ≥ 50 years, randomised (in a 2:1 ratio) in a double-blind manner to receive 0.5 mg (0.05 mL) intravitreal injection of either Sun's ranibizumab or reference ranibizumab in the study eye every 4 weeks until week 16 (total of four doses). RESULTS: Primary endpoint results demonstrated equivalence in the proportion of patients who lost fewer than 15 letters from baseline best-corrected visual acuity (BCVA) to the end of week 16 (99% of patients in Sun's ranibizumab and 100% in reference ranibizumab; p > 0.9999), with the proportional difference (90% confidence interval) at -1% (-2.51, +0.61) lying within a pre-specified equivalence margin. Visual acuity improved by 15 or more letters in 43% of Sun's ranibizumab group and 37% of the reference ranibizumab group (p = 0.4267). The mean increase in BCVA was 15.7 letters in Sun's ranibizumab group and 14.6 letters in the reference ranibizumab group (p < 0.001 within both groups and p = 0.5275 between groups). The mean change in central macular thickness was comparable between groups (p = 0.7946). Anti-ranibizumab antibodies were found in one patient of the reference ranibizumab group, while neutralising antibodies were not found in any patients. Both products were well tolerated. CONCLUSION: Sun's ranibizumab biosimilar is found to be therapeutically equivalent to reference ranibizumab in patients with nAMD. There were no additional safety or immunogenicity concerns. TRIAL REGISTRATION: CTRI/2020/09/027629, registered on 07 September 2020.
RESUMEN
PURPOSE: To describe the clinical presentation and imaging features of a patient with acute lymphoblastic leukemia that was complicated by optic nerve leukemic infiltration. METHODS: A 36-year-old man with history of acute lymphoblastic leukemia on treatment presented with decreased vision and optic nerve leukemic infiltrates. RESULTS: At presentation, ocular examination revealed decreased visual acuity at hand movement close to face in his right eye and 20/120 in his left eye. Fundus examination showed a pale optic disk with blurred margins and multiple flame-shaped and dot and blot retinal hemorrhages in his right eye and disk edema with whitish leukemic infiltrates over it with few dot and blot retinal hemorrhages in his left eye. The patient was referred to the treating oncologist, and curative orbital radiotherapy was administered. Vision improved dramatically to 20/40 in the right eye and to 20/20 in the left eye. He again reported with complaints of blurring of vision in the left eye after 1 month. Visual acuity was 20/20, but fundus revealed severe disk edema with whitish leukemic infiltrates. We diagnosed as relapse of leukemic optic nerve infiltration and referred to the treating oncologist for further management. CONCLUSION: Isolated optic nerve relapse of leukemic infiltration is of paramount importance to early diagnosis, as vision can be saved if treatment is initiated promptly.
