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Rainbow Extension Study

NCT ID: NCT02640664

Last Updated: 2023-02-13

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-16

Study Completion Date

2022-04-21

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Retinopathy of Prematurity (ROP)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ranibizumab 0.2 mg

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

Group Type EXPERIMENTAL

Ranibizumab

Intervention Type DRUG

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

Ranibizumab 0.1 mg

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

Group Type EXPERIMENTAL

Ranibizumab

Intervention Type DRUG

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

Laser therapy

Laser therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ranibizumab

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Sacramento, California, United States

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Aurora, Colorado, United States

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Chicago, Illinois, United States

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Louisville, Kentucky, United States

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Baltimore, Maryland, United States

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Ann Arbor, Michigan, United States

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Rochester, New York, United States

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Austin, Texas, United States

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Morgantown, West Virginia, United States

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Graz, , Austria

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Vienna, , Austria

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Bruges, , Belgium

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Ghent, , Belgium

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Zagreb, , Croatia

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Praha 4 - Podoli, Czech Republic, Czechia

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Ostrava, Poruba, Czechia

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Prague, , Czechia

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Koebenhavn Ø, , Denmark

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Alexandria, , Egypt

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Tallinn, , Estonia

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Amiens, , France

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Marseille, , France

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Hanover, , Germany

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Ampelokipoi, GR, Greece

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Thessaloniki, GR, Greece

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Athens, , Greece

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Budapest, , Hungary

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Debrecen, , Hungary

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Ahmedabad, Gujarat, India

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Mumbai, Maharashtra, India

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Coimbatore, Tamil Nadu, India

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Madurai, Tamil Nadu, India

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Vanchiyoor, Thiruvanantapuram, India

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New Delhi, , India

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Florence, FI, Italy

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Perugia, PG, Italy

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Fiumicino, RM, Italy

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Roma, RM, Italy

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Nagoya, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Yachiyo, Chiba, Japan

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Fukuoka, Fukuoka, Japan

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Fukuoka, Fukuoka, Japan

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Kurume, Fukuoka, Japan

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Sapporo, Hokkaido, Japan

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Zentsujichó, Kagawa-ken, Japan

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Shimajiri-Gun, Okinawa, Japan

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Izumi, Osaka, Japan

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Ohtsu-city, Shiga, Japan

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Fuchū, Tokyo, Japan

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Ōta-ku, Tokyo, Japan

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Setagaya-ku, Tokyo, Japan

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Sumida-ku, Tokyo, Japan

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Toshima-ku, Tokyo, Japan

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Kaunas, LTU, Lithuania

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Kuala Lumpur, Kuala Lumpur, Malaysia

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Kota Kinabalu, Sabah, Malaysia

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Brasov, , Romania

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Bucharest, , Romania

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Timișoara, , Romania

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Cheboksary, , Russia

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Kazan', , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Riyadh, , Saudi Arabia

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Bratislava, , Slovakia

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Taipei, , Taiwan

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Taoyuan District, , Taiwan

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Istanbul, Bakirkoy, Turkey (Türkiye)

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Meselik, Eskişehir, Turkey (Türkiye)

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Soguksu / Antalya, Turkey, Turkey (Türkiye)

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Manchester, , United Kingdom

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Portsmouth, , United Kingdom

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Countries

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United States Austria Belgium Croatia Czechia Denmark Egypt Estonia France Germany Greece Hungary India Italy Japan Lithuania Malaysia Romania Russia Saudi Arabia Slovakia Taiwan Turkey (Türkiye) United Kingdom

References

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Marlow N, Reynolds JD, Lepore D, Fielder AR, Stahl A, Hao H, Weisberger A, Lodha A, Fleck BW. Ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW): five-year outcomes of a randomised trial. EClinicalMedicine. 2024 Apr 11;71:102567. doi: 10.1016/j.eclinm.2024.102567. eCollection 2024 May.

Reference Type DERIVED
PMID: 38638400 (View on PubMed)

Marlow N, Stahl A, Lepore D, Fielder A, Reynolds JD, Zhu Q, Weisberger A, Stiehl DP, Fleck B; RAINBOW investigators group. 2-year outcomes of ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW extension study): prospective follow-up of an open label, randomised controlled trial. Lancet Child Adolesc Health. 2021 Oct;5(10):698-707. doi: 10.1016/S2352-4642(21)00195-4. Epub 2021 Aug 13.

Reference Type DERIVED
PMID: 34391532 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2014-004048-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CRFB002H2301E1

Identifier Type: -

Identifier Source: org_study_id

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