研究目的
To evaluate the efficacy and safety of intravitreal ranibizumab compared with laser therapy in the treatment of ROP.
研究成果
Ranibizumab 0·2 mg was as effective and safe in the treatment of active ROP as laser therapy, might be superior, and was associated with better short-term ocular outcomes.
研究不足
The study was limited by slow enrolment, which led to a modified recruitment target and reduced power. The trial was open label, not masked, and used no placebo. Decisions on retreatment were made on an individual basis and retreatment with ranibizumab restricted to intervals of 28 days.
1：Experimental Design and Method Selection:
A randomised, open-label, superiority multicentre, three-arm, parallel group trial was conducted in 87 neonatal and ophthalmic centres in 26 countries. Infants with birthweight less than 1500 g who met criteria for treatment for retinopathy were randomised equally (1:1:1) to receive a single bilateral intravitreal dose of ranibizumab 0·2 mg or ranibizumab 0·1 mg, or laser therapy.
2：Sample Selection and Data Sources:
Infants were stratified by disease zone and geographical region using computer interactive response technology.
3：List of Experimental Equipment and Materials:
Ranibizumab and laser therapy equipment were used.
4：Experimental Procedures and Operational Workflow:
The primary outcome was survival with no active retinopathy, no unfavourable structural outcomes, or need for a different treatment modality at or before 24 weeks.
5：Data Analysis Methods:
Analysis was by intention to treat.
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