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

CRFB002H2301E1

The purpose of this study was to evaluate the long term efficacy and safety of intravitreal ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy of prematurity (ROP) in the core study CRFB002H2301 (NCT02375971)

2016-06-16

2022-04-21

2022-04-21

Completed

Early phase I

180

Inclusion Criteria: * Signed informed consent from parent(s) or legal guardian(s), in compliance with local requirements * The patient successfully completed the core study H2301, as defined by providing assessments at the Visit 112 (the last scheduled visit in the core study) or, if appropriate, at the last of the additional assessment visits as per protocol in H2301, whichever was latest * The patient received study treatment in both eyes at baseline of study H2301 Exclusion Criteria: * Patient had a medical condition or personal circumstance which precluded study participation or compliance with study procedures, as assessed by the Investigator * Patient had been discontinued from the core study H2301 at any time

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 180, 'type': 'ACTUAL'}}

2023-02-13