Rainbow Extension Study

Completed · Phase 3

Conditions studied: Retinopathy of Prematurity (ROP)

In brief

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)

Key facts

Study ID

NCT02640664

Run by

Novartis Pharmaceuticals

People needed

180

Starts

2016-06-16

Expected to finish

2022-04-21

Last updated by the study team

2023-02-13

Who can join

Age: 1 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Aurora, Colorado, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Louisville, Kentucky, United States
• Novartis Investigative Site — Baltimore, Maryland, United States
• Novartis Investigative Site — Ann Arbor, Michigan, United States
• Novartis Investigative Site — Rochester, New York, United States
• Novartis Investigative Site — Austin, Texas, United States
• Novartis Investigative Site — Morgantown, West Virginia, United States
• Novartis Investigative Site — Graz, Austria
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Bruges, Belgium
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Zagreb, Croatia
• Novartis Investigative Site — Praha 4 - Podoli, Czech Republic, Czechia
• Novartis Investigative Site — Ostrava, Poruba, Czechia
• Novartis Investigative Site — Prague, Czechia
• Novartis Investigative Site — Koebenhavn Ø, Denmark
• Novartis Investigative Site — Alexandria, Egypt
• Novartis Investigative Site — Tallinn, Estonia
• Novartis Investigative Site — Amiens, France
• Novartis Investigative Site — Marseille, France
• Novartis Investigative Site — Hanover, Germany
• Novartis Investigative Site — Ampelokipoi, GR, Greece
• Novartis Investigative Site — Thessaloniki, GR, Greece
• Novartis Investigative Site — Sacramento, California, United States

Full record on ClinicalTrials.gov

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