Rainbow Extension Study (RainbowExt)

RAINBOW Extension Study: an Extension Study to Evaluate the Long Term Efficacy and Safety of RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223333

Enrollment

Registered

2016-09-29

Start date

2016-10-28

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 m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: *The patient successfully completed the core study CRFB002H2301 *The patient received study treatment in both eyes at baseline of study CRFB002H2301

Exclusion criteria

Exclusion criteria: *Patient has a medical condition or personal circumstance which precludes study participation or compliance with study procedures, as assessed by the Investigator *Patient has been discontinued from the core study CRFB002H2301 at any time Other protocol-defined inclusion/exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
safety efficacy Visual function [Time Frame: at the patient's fifth birthday] Visual acuity in the better-seeing eye	—

Secondary

Measure	Time frame
safety Number of patients having any ocular Adverse Event [Time Frame: at the patient's fifth birthday] safety Number of patients having any systemic Adverse Event [Time Frame: at the patient's fifth birthday] efficacy Visual function [Time Frame: at the patient's fifth birthday] Visual acuity in the worse-seeing eye	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania, South America

Outcome results

None listed

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