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NCT02375971 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
224
Enrollment target

NCT02375971: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.

NCT02375971 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 224 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02375971, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
224 participants
Enrollment target

Study Summary

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).

Primary Outcome

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. Retinopathy of prematurity (ROP) is a pathologic process that occurs in the incompletely vascularized, developing retina of low birth-weight preterm neonates.

Interventions

  • DRUG Ranibizumab
  • PROCEDURE Laser therapy

Trial Details

FieldValue
Enrollment Target 224 participants
Start Date 2015-12-30
Est. Completion 2017-12-14
Phase Phase 3
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT02375971 record still lists

NCT02375971 is an interventional study that assigns participants to a tested intervention. The registered 224 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower).

The record links to 0 conditions, and to 2 interventions - of which Ranibizumab is the first listed.

NCT02375971 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02375971 about?

NCT02375971 is a clinical study titled "RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity". 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).

What is the current status of trial NCT02375971?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 224 participants. The study started on 2015-12-30. Estimated completion is 2017-12-14.

What interventions are being tested in trial NCT02375971?

The interventions under investigation include: Ranibizumab (DRUG), Laser therapy (PROCEDURE).

Who is sponsoring clinical trial NCT02375971?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02375971's enrollment target sits among peer trials

224 1317th of 2000 higher than 684 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02375971, the US trial registry maintained by the National Library of Medicine. NCT02375971 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.