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

Novartis

Status and phase: Completed; Phase 3

Conditions: Retinopathy of Prematurity

Treatments: Procedure: Laser therapy; Drug: Ranibizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02375971

CRFB002H2301

2014-003041-10 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study was to determine if intravitreal ranibizumab is superior to laser ablation therapy in the treatment of retinopathy of prematurity (ROP).

Full description

The study consisted of a screening period (screening and randomization could occur up to 3 days before the administration of the first investigational treatment), followed by a treatment and follow-up period (Day 1 to Day 169).

Enrollment: 224 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• preterm infants with a birth weight of less than 1500 g
• bilateral ROP with one 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 retinopathy of prematurity (AP-ROP)

Exclusion criteria

• ROP disease characteristic in either eye other than that listed above at the time of the first investigational treatment
• A history of hypersensitivity (either the patient or the mother) to any of the investigational treatments or to drugs of similar chemical classes
• Had received any previous surgical or nonsurgical treatment for ROP (e.g., ablative laser therapy or cryotherapy, vitrectomy)
• Had been previously exposed to any intravitreal or systemic anti-VEGF agent (either the patient or the mother during this child's pregnancy)
• Had used (either the patient or the mother) other investigational drugs as part of another clinical study (other than vitamins and minerals) within 30 days or within 5 half-lives of the other investigational drug, whichever was longer
• Had ocular structural abnormalities that were assessed by the Investigator to have had a clinically significant impact on study assessments
• Had active ocular infection within 5 days before or on the day of first investigational treatment
• Had a history of hydrocephalus requiring treatment
• Had a history of any other neurological conditions that are assessed by the Investigator to have a significant risk of severe impact on visual function
• Had any other medical conditions or clinically significant comorbidities or personal circumstances that were assessed by the Investigator to have a clinically relevant impact on study participation, any of the study procedures, or on efficacy assessments (e.g., poor life expectancy, pupil not able to be adequately dilated, unable to comply with the visit schedule)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 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

Active Comparator group

Description:

Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed

Treatment:

Procedure: Laser therapy