Rainbow Extension Study (RainbowExt)

Novartis

Status and phase: Completed; Phase 3

Conditions: Retinopathy of Prematurity (ROP)

Treatments: Drug: Ranibizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02640664

2014-004048-36 (EudraCT Number)

CRFB002H2301E1

Details and patient eligibility

About

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)

Full description

This was a multicenter, open-label extension study where the Visual Acuity (VA) assessment at the child's 5th birthday visit was performed. The study had 2 distinct periods (Epochs). Treatment with study ranibizumab (either as retreatment after ranibizumab had already been injected in the same eye or as switch ranibizumab treatment from study laser therapy administered in the core study) was permitted for eligible eyes with recurrence/worsening of ROP up to and including Week 40 from the baseline visit in the core study (Epoch 1). The remainder of the extension study up to the 5th birthday visit (Epoch 2) was observational, with no study treatment planned to be administered.

In the core study, patients were randomized to 1 of the 3 treatment arms (ranibizumab 0.2 mg, ranibizumab 0.1 mg, and laser). Treatment arm assignment and patient identifier in the extension study remained the same as in the core study.

Enrollment: 180 patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

Ranibizumab 0.2 mg

Experimental group

Description:

1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required

Treatment:

Drug: Ranibizumab

Ranibizumab 0.1 mg

Experimental group

Description:

1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required

Treatment:

Drug: Ranibizumab

Laser therapy

No Intervention group

Description:

Laser therapy