Rainbow Extension Study

NCT02640664 | Completed Phase 3 Results DMC

• 2 other identifiers: CRFB002H2301E12014-004048-36
• Study Type: interventional
• Target: 180
• Locations: 24 countries
• Sites: 73

Brief 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)

Conditions

Retinopathy of Prematurity (ROP)

Keywords

open-label,; long-term,; extension study,; intravitreal ranibizumab,; laser ablation therapy,; retinopathy of prematurity,; preterm infants,; RAINBOW

Outcome Measures

Primary Outcomes (1)

• Visual Acuity (VA) of the Better-seeing Eye at the Participant's Fifth Birthday Visit - Comparison Between Treatment Arms

  The VA assessment at the child's 5th birthday visit was performed using Early Treatment Diabetic Retinopathy Study (ETDRS) methodology. VA measurements were taken in a sitting position at an initial test distance of 3 meters using Lea Symbols charts. Scores represented the number of optotypes (Lea symbols) the participant identified and ranged from 0 to 100, with higher scores indicating better visual acuity. VA was tested in each eye, using the child's current refractive index. The better-seeing eye was defined as the eye with the higher ETDRS score at the 5th birthday visit. If both eyes had the same ETDRS score, then the right eye was assigned as the better-seeing eye.

  at the participant's fifth birthday visit (maximum 5 years and 4 months post core baseline visit)

Secondary Outcomes (24)

• Number of Participants With Ocular Adverse Events (AEs) Regardless of Study Treatment or Procedure Relationship by Preferred Term

  throughout the study, approximately 5 years

• Number of Participants With Non-ocular Adverse Events (AEs) Regardless of Study Treatment or Procedure Relationship (Greater Than or Equal to 3% in Any Arm) by Preferred Term

  throughout the study, approximately 5 years

• Visual Acuity (VA) of the Worse-seeing Eye at the Participant's Fifth Birthday Visit - Comparison Between Treatment Arms

  at the participant's fifth birthday visit (maximum 5 years and 4 months post core baseline visit)

• Number of Participants With Absence of Active Retinopathy of Prematurity (ROP) at 40 Weeks Post Core Baseline Visit

  at 40 weeks post core baseline visit

• Number of Participants With Absence of Active Retinopathy of Prematurity (ROP) at 52 Weeks Post Core Baseline Visit

  at 52 weeks post core baseline visit

Study Arms (3)

Ranibizumab 0.2 mg

EXPERIMENTAL

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

Drug: Ranibizumab

Ranibizumab 0.1 mg

EXPERIMENTAL

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

Drug: Ranibizumab

Laser therapy

NO INTERVENTION

Laser therapy

Interventions

Ranibizumab 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; Ranibizumab 0.2 mg

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (73)

Novartis Investigative Site

Sacramento, California, 95817, United States

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Aurora, Colorado, 80045, United States

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Chicago, Illinois, 60612, United States

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Louisville, Kentucky, 40202, United States

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Baltimore, Maryland, 21201, United States

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Ann Arbor, Michigan, 48105, United States

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Rochester, New York, 14642, United States

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Austin, Texas, 78705, United States

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Morgantown, West Virginia, 26506, United States

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Graz, A-8036, Austria

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Vienna, 1090, Austria

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Bruges, 8000, Belgium

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Ghent, 9000, Belgium

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Zagreb, 10000, Croatia

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Praha 4 - Podoli, Czech Republic, 14700, Czechia

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Ostrava, Poruba, 708 52, Czechia

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Prague, 12808, Czechia

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Koebenhavn Ø, 2100, Denmark

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Alexandria, 21131, Egypt

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Tallinn, 10138, Estonia

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Amiens, 80054, France

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Marseille, 13915, France

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Hanover, 30625, Germany

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Ampelokipoi, GR, 115 27, Greece

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Thessaloniki, GR, 564 03, Greece

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Athens, 115 27, Greece

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Budapest, 1125, Hungary

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Debrecen, 4032, Hungary

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Ahmedabad, Gujarat, 380016, India

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Mumbai, Maharashtra, 400 008, India

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Coimbatore, Tamil Nadu, 641014, India

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Madurai, Tamil Nadu, 625020, India

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Vanchiyoor, Thiruvanantapuram, 695035, India

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New Delhi, 110029, India

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Florence, FI, 50139, Italy

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Perugia, PG, 06100, Italy

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Fiumicino, RM, 00054, Italy

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Roma, RM, 00168, Italy

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Nagoya, Aichi-ken, 453-8511, Japan

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Nagoya, Aichi-ken, 466 8560, Japan

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Yachiyo, Chiba, 276-8524, Japan

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Fukuoka, Fukuoka, 812-8582, Japan

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Fukuoka, Fukuoka, 814 0180, Japan

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Kurume, Fukuoka, 830-0011, Japan

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Sapporo, Hokkaido, Japan

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Zentsujichó, Kagawa-ken, 765-8507, Japan

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Shimajiri-Gun, Okinawa, 901-1303, Japan

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Izumi, Osaka, 594-1101, Japan

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Ohtsu-city, Shiga, 520-2192, Japan

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Fuchū, Tokyo, 183-8561, Japan

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Ōta-ku, Tokyo, 143 8541, Japan

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Setagaya-ku, Tokyo, 157-8535, Japan

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Sumida-ku, Tokyo, 130-8575, Japan

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Toshima-ku, Tokyo, 170-8476, Japan

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Kaunas, LTU, LT 50161, Lithuania

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Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

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Kota Kinabalu, Sabah, 88996, Malaysia

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Brasov, 500025, Romania

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Bucharest, 020395, Romania

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Timișoara, 300041, Romania

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Cheboksary, 428028, Russia

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Kazan', 420012, Russia

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Moscow, 127486, Russia

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Saint Petersburg, 194100, Russia

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Riyadh, 11211, Saudi Arabia

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Bratislava, 833 40, Slovakia

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Taipei, 10002, Taiwan

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Taoyuan District, 33305, Taiwan

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Istanbul, Bakirkoy, 34140, Turkey (Türkiye)

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Novartis Investigative Site

Meselik, Eskişehir, 26480, Turkey (Türkiye)

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Novartis Investigative Site

Soguksu / Antalya, Turkey, 07100, Turkey (Türkiye)

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Novartis Investigative Site

Manchester, M13 9WL, United Kingdom

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Novartis Investigative Site

Portsmouth, PO6 3LY, United Kingdom

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Related Publications (2)

• 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.

  PMID: 38638400 DERIVED

• 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.

  PMID: 34391532 DERIVED

MeSH Terms

Conditions

Retinopathy of Prematurity

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 29, 2015
• Study Start: June 16, 2016
• Primary Completion: April 21, 2022
• Study Completion: April 21, 2022
• Last Updated: February 13, 2023
• Results First Posted: February 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share

Locations

JP (16); RU (4); TU (3); MY (2); RO (3); HU (2); SL (1); TW (2); DK (1); IT (4); BE (2); LI (1); IN (6); EG (1); GR (3); DE (1); ES (1); SA (1); US (9); CZ (3); AU (2); CR (1); FR (2); GB (2)