未熟児網膜症治療において、ラニビズマブの安全性がUB主導の研究で証明される(Study: For treating retinopathy of prematurity, UB-led research proves that ranibizumab is safe)

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2024-05-10 バッファロー大学(UB)

バッファロー大学の研究者であり、未熟児網膜症(ROP)の専門家が、この病気の治療標準を変える可能性のある研究を発表しました。ROPは低出生体重の早産児に発生し、治療されなければ失明につながることがあります。国際的な無作為化臨床試験RAINBOWでは、ROP治療において、レーザー療法と比較してラニビズマブの効果と安全性を評価しました。この研究は、ラニビズマブを製造するノバルティスファーマAGによって資金提供されました。研究の結果、ラニビズマブはレーザーよりも効果が同等かそれ以上であり、システム的な安全性も確認されました。

<関連情報>

未熟児網膜症の超低出生体重児に対するラニビズマブとレーザー治療の比較(RAINBOW):無作為化試験の5年間の成績 Ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW): five-year outcomes of a randomised trial

Neil Marlow, James D. Reynolds, Domenico Lepore, Alistair R. Fielder, Andreas Stahl, Han Hao, Annemarie Weisberger, Amit Lodha, Brian W. Fleck
eClinicalMedicine  Available online:11 April 2024
DOI:https://doi.org/10.1016/j.eclinm.2024.102567

Summary

Background
Concerns remain over the long-term safety of vascular endothelial growth factor (VEGF) inhibitors to treat retinopathy of prematurity (ROP). RAINBOW is an open label randomised trial comparing intravitreal ranibizumab (in 0.2 mg and 0.1 mg doses) with laser therapy in very low birthweight infants (<1500 g) with ROP.

Methods
Of 201 infants completing RAINBOW, 180 were enrolled in the RAINBOW Extension Study. At 5 years, children underwent ophthalmic, development and health assessments. The primary outcome was visual acuity in the better-seeing eye. The study is registered with ClinicalTrial.gov, NCT02640664.

Findings
Between 16-6-2016 and 21-4-2022, 156 children (87%) were evaluated at 5 years. Of 32 children with no acuity test result, 25 had a preferential looking test, for 4 children investigators reported low vision for each eye, and in 3 further children no vision measurement was obtained. 124 children completed the acuity assessment, the least square mean (95% CI) letter score in the better seeing eye was similar in the three trial arms—66.8 (62.9–70.7) following ranibizumab 0.2 mg, 64.6 (60.6–68.5) following ranibizumab 0.1 mg and 62.1 (57.8–66.4) following laser therapy; differences in means: ranibizumab 0.2 mg v laser: 4.7 (95% CI: -1.1, 10.5); 0.1 mg v laser: 2.5 (-3.4, 8.3); 0.2 mg v 0.1 mg: 2.2 (-3.3, 7.8). High myopia (worse than -5 dioptres) in at least one eye occurred in 4/52 (8%) children following ranibizumab 0.2 mg, 8/55 (15%) following ranibizumab 0.1 mg and 11/45 (24%) following laser therapy (0.2 mg versus laser: odds ratio: 3.99 (1.16–13.72)). Ocular and systemic secondary outcomes and adverse events were distributed similarly in each trial arm.

Interpretation
5-year outcomes confirm the findings of the original RAINBOW trial and a planned interim analysis at 2 years, including a reduced frequency of high myopia following ranibizumab treatment. No effects of treatment on non-ocular outcomes were detected.

Funding
Novartis Pharma AG.

医療・健康
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