Purpose <p>To evaluate the short-term clinical outcomes of CKD-701, a ranibizumab biosimilar, in treating vitreous hemorrhage (VH) secondary to proliferative diabetic retinopathy (PDR).</p> Methods <p>This retrospective study included 64 eyes of 64 patients with VH secondary to PDR who received intravitreal CKD-701 injections and were followed for at least four months. Visual acuity (VA) was assessed at baseline, at the first follow-up (mean 3.8 weeks), and at 2- and 4-months post-treatment. The incidences of recurrent VH and vitrectomy were recorded. The factors associated with the degree of visual improvement were analyzed.</p> Results <p>The patients received a mean of 1.8 ± 0.9 injections. VA significantly improved over time (mean logMAR VA: 1.29 ± 0.82 at baseline, 1.11 ± 0.84 at first follow-up, 0.94 ± 0.81 at 2 months, and 0.73 ± 0.68 at 4 months; <i>P</i> &lt; 0.001). The proportions of patients achieving 20/40 or better VA at each time point were 18.8%, 25.0%, 29.7%, and 40.6%, respectively. Recurrent VH occurred in 17.2% of patients, and vitrectomy was performed in 12.5%. There was no significant difference in 4-month VA between patients who did and did not undergo vitrectomy (<i>P</i> &gt; 0.999). Baseline VA was significantly associated with the degree of visual improvement (<i>P</i> = 0.010). No severe ocular complications were observed.</p> Conclusions <p>In this short-term study, VH secondary to PDR decreased following CKD-701 treatment and was accompanied by visual improvement. Further well-controlled long-term studies are needed to definitively assess the efficacy of CKD-701.</p>

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Short-term treatment outcomes of the ranibizumab biosimilar CKD-701 for vitreous hemorrhage secondary to proliferative diabetic retinopathy

  • So Hyun Yu,
  • Jaejin Cho,
  • Sang Min Park,
  • Chul Gu Kim,
  • Jae Hui Kim

摘要

Purpose

To evaluate the short-term clinical outcomes of CKD-701, a ranibizumab biosimilar, in treating vitreous hemorrhage (VH) secondary to proliferative diabetic retinopathy (PDR).

Methods

This retrospective study included 64 eyes of 64 patients with VH secondary to PDR who received intravitreal CKD-701 injections and were followed for at least four months. Visual acuity (VA) was assessed at baseline, at the first follow-up (mean 3.8 weeks), and at 2- and 4-months post-treatment. The incidences of recurrent VH and vitrectomy were recorded. The factors associated with the degree of visual improvement were analyzed.

Results

The patients received a mean of 1.8 ± 0.9 injections. VA significantly improved over time (mean logMAR VA: 1.29 ± 0.82 at baseline, 1.11 ± 0.84 at first follow-up, 0.94 ± 0.81 at 2 months, and 0.73 ± 0.68 at 4 months; P < 0.001). The proportions of patients achieving 20/40 or better VA at each time point were 18.8%, 25.0%, 29.7%, and 40.6%, respectively. Recurrent VH occurred in 17.2% of patients, and vitrectomy was performed in 12.5%. There was no significant difference in 4-month VA between patients who did and did not undergo vitrectomy (P > 0.999). Baseline VA was significantly associated with the degree of visual improvement (P = 0.010). No severe ocular complications were observed.

Conclusions

In this short-term study, VH secondary to PDR decreased following CKD-701 treatment and was accompanied by visual improvement. Further well-controlled long-term studies are needed to definitively assess the efficacy of CKD-701.