RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity

RAINBOW Study: a Randomized, Controlled Study Evaluating the Efficacy and Safety of RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223115

Enrollment

Registered

2016-02-24

Start date

2016-02-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinopathy of Prematurity

Interventions

investigational material(s) Generic name etc : Ranibizumab INN of investigational material : Therapeutic category code : 131 Agents for ophthalmic use Dosage and Administration for Investigational ma

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: *Preterm infants with a birth weight of less than 1500 g *Bilateral ROP with 1 of the following retinal findings in each eye:Zone I, stage 1+, 2+, 3 or 3+ disease, or Zone II, stage 3+ disease, or Aggressive posterior ROP

Exclusion criteria

Exclusion criteria: *Have received any previous surgical or nonsurgical treatment for ROP (e.g., ablative laser therapy or cryotherapy, vitrectomy) *Have been previously exposed to any intravitreal or systemic anti-VEGF agent (either the patient or the mother during this child's pregnancy) *Have ocular structural abnormalities that are assessed by the Investigator to have a clinically significant impact on study assessments *Have active ocular infection within 5 days before or on the day of first investigational treatment *Have any other medical conditions or clinically significant comorbidities or personal circumstances that are assessed by the Investigator to have a clinically relevant impact on study participation, any of the study procedures, or on efficacy assessments Other protocol defined inclusion/exclusion may apply

Design outcomes

Primary

Measure	Time frame
Absence of active Retinopathy of Prematurity (ROP) and unfavorable structural outcome [ Time Frame: 24 weeks after starting investigational treatment ] To achieve this outcome, patients must fulfill all the following criteria, 1) survival, 2) no intervention with a second modality for ROP, 3) absence of active ROP and 4) absence of unfavorable structural outcome	—

Secondary

Measure	Time frame
Requirement for intervention with a second modality for ROP [ Time Frame: 24 weeks after starting investigational treatment ] Time to intervention with a second modality for ROP or development of unfavorable structural outcome or death [ Time Frame: 24 weeks after starting investigational treatment ] Recurrence of ROP [ Time Frame: 24 weeks after starting investigational treatment ]	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026