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NCT02640664 · ClinicalTrials.gov registry record · Phase 3

Rainbow Extension Study

A Phase 3 study of Retinopathy of Prematurity (ROP), sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
180
Enrollment target
20
Study locations

NCT02640664 is a Phase 3 study of Retinopathy of Prematurity (ROP) that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 180 participants, below the 2,499-participant average among 3 other Retinopathy of Prematurity (ROP) trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT02640664, a Phase 3 study of Retinopathy of Prematurity (ROP), has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
180 participants
Enrollment target
20
Study locations

Study Summary

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)

Interventions

  • DRUG Ranibizumab

Study Locations (20)

Other

  • Novartis Investigative Site - Graz
  • Novartis Investigative Site - Vienna
  • Novartis Investigative Site - Bruges
  • Novartis Investigative Site - Ghent
  • Novartis Investigative Site - Zagreb
  • Novartis Investigative Site - Prague
  • Novartis Investigative Site - Koebenhavn Ø
  • Novartis Investigative Site - Alexandria
  • Novartis Investigative Site - Tallinn

California

  • Novartis Investigative Site - Sacramento

Colorado

  • Novartis Investigative Site - Aurora

Illinois

  • Novartis Investigative Site - Chicago

Kentucky

  • Novartis Investigative Site - Louisville

Maryland

  • Novartis Investigative Site - Baltimore

Michigan

  • Novartis Investigative Site - Ann Arbor

New York

  • Novartis Investigative Site - Rochester

Trial Details

FieldValue
Enrollment Target 180 participants
Start Date 2016-06-16
Est. Completion 2022-04-21
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT02640664

The ClinicalTrials.gov registry entry for NCT02640664 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,499-participant average among 3 other Retinopathy of Prematurity (ROP) trials with a reported enrollment target (93% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Retinopathy of Prematurity (ROP) appearing as the primary indexed condition, and to 1 intervention - of which Ranibizumab is the first listed.

NCT02640664 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT02640664 about?

NCT02640664 is a clinical study titled "Rainbow Extension Study". 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)

What is the current status of trial NCT02640664?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 180 participants. The study started on 2016-06-16. Estimated completion is 2022-04-21.

What conditions does trial NCT02640664 study?

This clinical trial studies the following conditions: Retinopathy of Prematurity (ROP).

What interventions are being tested in trial NCT02640664?

The interventions under investigation include: Ranibizumab (DRUG).

Who is sponsoring clinical trial NCT02640664?

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

Where is trial NCT02640664 being conducted?

This trial has 20 study locations across California, Colorado, Illinois, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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