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Rainbow Extension Study (RainbowExt)

Primary Purpose

Retinopathy of Prematurity (ROP)

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ranibizumab

About this trial

This is an interventional treatment trial for Retinopathy of Prematurity (ROP) focused on measuring open-label,, long-term,, extension study,, intravitreal ranibizumab,, laser ablation therapy,, retinopathy of prematurity,, preterm infants,, RAINBOW

Eligibility Criteria

6 Months - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The patient successfully completed the core study CRFB002H2301
The patient received study treatment in both eyes at baseline of study CRFB002H2301

Exclusion Criteria:

Patient has a medical condition or personal circumstance which precludes study participation or compliance with study procedures, as assessed by the Investigator
Patient has been discontinued from the core study CRFB002H2301 at any time

Other protocol-defined inclusion/exclusion criteria may apply

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Ranibizumab 0.2 mg

Ranibizumab 0.1 mg

Laser therapy

Arm Description

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

Laser therapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Number of participants with ocular AEs starting during the core study and ongoing at extension baseline, or starting on/after extension baseline were reported.

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

Number of participants with non-ocular adverse events regardless of study treatment or procedure relationship (greater than or equal to 3% in any arm) by preferred term were reported.

Visual Acuity (VA) of the Worse-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 worse-seeing eye was the eye with a lower ETDRS score at the 5th birthday visit. If both eyes had the same ETDRS score, then the left eye was assigned as the worse-seeing eye.

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

The absence of active ROP in both eyes is defined by the absence of all of the following features: (1) Vessel dilatation of plus disease in at least 2 quardrants (some persisting tortuosity is allowed), (2) Extra-retina vessels extending from the retina into the vitreous and judged to be a sign of active ROP disease.

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

Number of Participants With Absence of All Ocular Structural Abnormalities at or Before 40 Weeks Post Baseline Visit

The absence of all ocular structural abnormalities is defined by the absence of all of the following fundus features in both eyes at or before the given time point: (1) Substantial temporal retinal vessel dragging causing abnormal structural features/macular Ectopia, (2) Retrolental membrane obscuring the view of the posterior pole, (3) Posterior retinal fold involving the macula, (4) Retinal detachment involving the macula

Number of Participants With Absence of All Ocular Structural Abnormalities at or Before the Participant's Fifth Birthday Visit

Number of Participants With Absence of Individual Ocular Structural Abnormalities at or Before 40 Weeks Post Baseline Visit

Number of participants with absence of each structural abnormality in both eyes at or before the given time point: (1) Substantial temporal retinal vessel dragging causing abnormal structural features/macular Ectopia, (2) Retrolental membrane obscuring the view of the posterior pole, (3) Posterior retinal fold involving the macula, (4) Retinal detachment involving the macula, (5) Retinal detachment not involving the macula, (6) Pre-retinal fibrosis

Number of Participants With Absence of Individual Ocular Structural Abnormalities at or Before the Participant's Fifth Birthday Visit

Number of Participants With Absence of All Ocular Structural Abnormalities at or Before Participant's 2 Years Corrected Age Visit

Number of Participants With Absence of Individual Ocular Structural Abnormalities at or Before Participant's 2 Years Corrected Age Visit

Number of Participants With Recurrence of ROP up to 40 Weeks Post Baseline Visit in the Core Study

Recurrence of ROP was defined as ROP receiving any post-baseline intervention after the 1st study treatment in the core study. In the ranibizumab arms, post-baseline interventions were ranibizumab retreatment or switch to laser. In the laser arm, post-baseline interventions were supplementary laser treatments after 11 days post-baseline, or switch to ranibizumab; supplementary laser treatment within 11 days post-baseline was not counted as recurrence.

Number of Participants With Recurrence of ROP up to 52 Weeks Post Baseline Visit in the Core Study

Number of Ranibizumab Injections Received Per Participant Over the Whole Safety Observation Period

Number of ranibizumab injections received in the treatment of participants with ROP up to and including 40 weeks post baseline visit in the core study were reported.

Refraction Status: Summary of Participants at Participant's 2 Years Corrected Age

Summary of participants was reported to evaluate the refraction in each eye at the participant's 2 years corrected age

Refraction Status: Summary of Participants at the Participant's Fifth Birthday Visit

Summary of participants was reported to evaluate the refraction in each eye at the participant's 2 years' corrected age

Change From Baseline in Weight

Subject´s weight was reported to evaluate the physical development.

Change From Baseline in Head Circumference

Subject´s head circumference was reported to evaluate the physical development.

Change From Baseline in Sitting Diastolic Blood Pressure

Subject´s Sitting Diastolic Blood Pressure was reported to evaluate the physical development.

Change From Baseline in Sitting Systolic Blood Pressure

Subject´s Sitting Systolic Blood Pressure was reported to evaluate the physical development.

Number of Participants With the Summary of Respiratory Function Status

Number of participants with respiratory function status was reported

Number of Participants With Hearing Impairment of Any Type

Number of participants with hearing function status was reported

Duration of Hospitalization

Duration of hospitalization (from birth to first hospital discharge home) was reported to evaluate the health status of the subject

Weight at the Time of First Hospital Discharge

Weight (gram) at the time of first hospital discharge was reported to evaluate the health status of the subject

Full Information

NCT ID

NCT02640664

First Posted

December 1, 2015

Last Updated

January 18, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02640664

Brief Title

Rainbow Extension Study

Acronym

RainbowExt

Official Title

RAINBOW Extension Study: an Extension Study to Evaluate the Long Term Efficacy and Safety of RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

June 16, 2016 (Actual)

Primary Completion Date

April 21, 2022 (Actual)

Study Completion Date

April 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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)

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinopathy of Prematurity (ROP)

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

180 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ranibizumab 0.2 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Ranibizumab 0.1 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Laser therapy

Arm Type

No Intervention

Arm Description

Laser therapy

Intervention Type

Drug

Intervention Name(s)

Ranibizumab

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Number of participants with ocular AEs starting during the core study and ongoing at extension baseline, or starting on/after extension baseline were reported.

Time Frame

throughout the study, approximately 5 years

Title

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

Description

Number of participants with non-ocular adverse events regardless of study treatment or procedure relationship (greater than or equal to 3% in any arm) by preferred term were reported.

Time Frame

throughout the study, approximately 5 years

Title

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

Description

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 worse-seeing eye was the eye with a lower ETDRS score at the 5th birthday visit. If both eyes had the same ETDRS score, then the left eye was assigned as the worse-seeing eye.

Time Frame

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

Title

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

Description

Time Frame

at 40 weeks post core baseline visit

Title

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

Description

Time Frame

at 52 weeks post core baseline visit

Title

Number of Participants With Absence of All Ocular Structural Abnormalities at or Before 40 Weeks Post Baseline Visit

Description

Time Frame

at or before 40 weeks post baseline visit

Title

Number of Participants With Absence of All Ocular Structural Abnormalities at or Before the Participant's Fifth Birthday Visit

Description

Time Frame

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

Title

Number of Participants With Absence of Individual Ocular Structural Abnormalities at or Before 40 Weeks Post Baseline Visit

Description

Time Frame

at or before 40 weeks post baseline visit

Title

Number of Participants With Absence of Individual Ocular Structural Abnormalities at or Before the Participant's Fifth Birthday Visit

Description

Time Frame

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

Title

Number of Participants With Absence of All Ocular Structural Abnormalities at or Before Participant's 2 Years Corrected Age Visit

Description

Time Frame

at or before participant's 2 years corrected age visit (up to 2 years and 4 months post core baseline visit)

Title

Number of Participants With Absence of Individual Ocular Structural Abnormalities at or Before Participant's 2 Years Corrected Age Visit

Description

Time Frame

at or before participant's 2 years corrected age visit (up to 2 years and 4 months post core baseline visit)

Title

Number of Participants With Recurrence of ROP up to 40 Weeks Post Baseline Visit in the Core Study

Description

Time Frame

up to 40 weeks post baseline visit in the core study

Title

Number of Participants With Recurrence of ROP up to 52 Weeks Post Baseline Visit in the Core Study

Description

Time Frame

up to 52 weeks post baseline visit in the core study

Title

Number of Ranibizumab Injections Received Per Participant Over the Whole Safety Observation Period

Description

Number of ranibizumab injections received in the treatment of participants with ROP up to and including 40 weeks post baseline visit in the core study were reported.

Time Frame

up to and including 40 weeks post baseline visit in the core study

Title

Refraction Status: Summary of Participants at Participant's 2 Years Corrected Age

Description

Summary of participants was reported to evaluate the refraction in each eye at the participant's 2 years corrected age

Time Frame

at participant's 2 years corrected age (maximum 2 years and 4 months post core baseline visit)

Title

Refraction Status: Summary of Participants at the Participant's Fifth Birthday Visit

Description

Summary of participants was reported to evaluate the refraction in each eye at the participant's 2 years' corrected age

Time Frame

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

Title

Change From Baseline in Weight

Description

Subject´s weight was reported to evaluate the physical development.

Time Frame

Baseline of the core study, at the subject's 2 years' corrected age (maximum 2 years and 4 months post core baseline visit) and at the subjects' fifth birthday (maximum 5 years and 4 months post core baseline visit)

Title

Change From Baseline in Head Circumference

Description

Subject´s head circumference was reported to evaluate the physical development.

Time Frame

Baseline of the core study and at the subject's 2 years' corrected age (maximum 2 years and 4 months post core baseline visit)

Title

Change From Baseline in Sitting Diastolic Blood Pressure

Description

Subject´s Sitting Diastolic Blood Pressure was reported to evaluate the physical development.

Time Frame

Baseline of the core study and at the subject's 2 years' corrected age (maximum 2 years and 4 months post core baseline visit)

Title

Change From Baseline in Sitting Systolic Blood Pressure

Description

Subject´s Sitting Systolic Blood Pressure was reported to evaluate the physical development.

Time Frame

Baseline of the core study and at the subject's 2 years' corrected age (maximum 2 years and 4 months post core baseline visit)

Title

Number of Participants With the Summary of Respiratory Function Status

Description

Number of participants with respiratory function status was reported

Time Frame

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

Title

Number of Participants With Hearing Impairment of Any Type

Description

Number of participants with hearing function status was reported

Time Frame

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

Title

Duration of Hospitalization

Description

Duration of hospitalization (from birth to first hospital discharge home) was reported to evaluate the health status of the subject

Time Frame

From baseline of the core study up to 5 years and 4 months post core baseline visit

Title

Weight at the Time of First Hospital Discharge

Description

Weight (gram) at the time of first hospital discharge was reported to evaluate the health status of the subject

Time Frame

From baseline of the core study up to 5 years and 4 months post core baseline visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Novartis Investigative Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Novartis Investigative Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Novartis Investigative Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Novartis Investigative Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

Novartis Investigative Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48105

Country

United States

Facility Name

Novartis Investigative Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Name

Novartis Investigative Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

Novartis Investigative Site

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506

Country

United States

Facility Name

Novartis Investigative Site

City

Graz

ZIP/Postal Code

A-8036

Country

Austria

Facility Name

Novartis Investigative Site

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Facility Name

Novartis Investigative Site

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Praha 4 - Podoli

State/Province

Czech Republic

ZIP/Postal Code

14700

Country

Czechia

Facility Name

Novartis Investigative Site

City

Ostrava

State/Province

Poruba

ZIP/Postal Code

708 52

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha

ZIP/Postal Code

12808

Country

Czechia

Facility Name

Novartis Investigative Site

City

Koebenhavn Ø

ZIP/Postal Code

2100

Country

Denmark

Facility Name

Novartis Investigative Site

City

Alexandria

ZIP/Postal Code

21131

Country

Egypt

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

10138

Country

Estonia

Facility Name

Novartis Investigative Site

City

Amiens

ZIP/Postal Code

80054

Country

France

Facility Name

Novartis Investigative Site

City

Marseille

ZIP/Postal Code

13915

Country

France

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Novartis Investigative Site

City

Ampelokipi

State/Province

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

State/Province

ZIP/Postal Code

564 03

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1125

Country

Hungary

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Novartis Investigative Site

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380016

Country

India

Facility Name

Novartis Investigative Site

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400 008

Country

India

Facility Name

Novartis Investigative Site

City

Coimbatore

State/Province

Tamil Nadu

ZIP/Postal Code

641014

Country

India

Facility Name

Novartis Investigative Site

City

Madurai

State/Province

Tamil Nadu

ZIP/Postal Code

625020

Country

India

Facility Name

Novartis Investigative Site

City

Vanchiyoor

State/Province

Thiruvanantapuram

ZIP/Postal Code

695035

Country

India

Facility Name

Novartis Investigative Site

City

New Delhi

ZIP/Postal Code

110029

Country

India

Facility Name

Novartis Investigative Site

City

Firenze

State/Province

ZIP/Postal Code

50139

Country

Italy

Facility Name

Novartis Investigative Site

City

Perugia

State/Province

ZIP/Postal Code

06100

Country

Italy

Facility Name

Novartis Investigative Site

City

Fiumicino

State/Province

ZIP/Postal Code

00054

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00168

Country

Italy

Facility Name

Novartis Investigative Site

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

453-8511

Country

Japan

Facility Name

Novartis Investigative Site

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

466 8560

Country

Japan

Facility Name

Novartis Investigative Site

City

Yachiyo-city

State/Province

Chiba

ZIP/Postal Code

276-8524

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuoka city

State/Province

Fukuoka

ZIP/Postal Code

812-8582

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuoka city

State/Province

Fukuoka

ZIP/Postal Code

814 0180

Country

Japan

Facility Name

Novartis Investigative Site

City

Kurume city

State/Province

Fukuoka

ZIP/Postal Code

830-0011

Country

Japan

Facility Name

Novartis Investigative Site

City

Sapporo-city

State/Province

Hokkaido

Country

Japan

Facility Name

Novartis Investigative Site

City

Zentsuji-city

State/Province

Kagawa

ZIP/Postal Code

765-8507

Country

Japan

Facility Name

Novartis Investigative Site

City

Shimajiri-Gun

State/Province

Okinawa

ZIP/Postal Code

901-1303

Country

Japan

Facility Name

Novartis Investigative Site

City

Izumi-city

State/Province

Osaka

ZIP/Postal Code

594-1101

Country

Japan

Facility Name

Novartis Investigative Site

City

Ohtsu-city

State/Province

Shiga

ZIP/Postal Code

520-2192

Country

Japan

Facility Name

Novartis Investigative Site

City

Fuchu-city

State/Province

Tokyo

ZIP/Postal Code

183-8561

Country

Japan

Facility Name

Novartis Investigative Site

City

Ota-ku

State/Province

Tokyo

ZIP/Postal Code

143 8541

Country

Japan

Facility Name

Novartis Investigative Site

City

Setagaya-ku

State/Province

Tokyo

ZIP/Postal Code

157-8535

Country

Japan

Facility Name

Novartis Investigative Site

City

Sumida-ku

State/Province

Tokyo

ZIP/Postal Code

130-8575

Country

Japan

Facility Name

Novartis Investigative Site

City

Toshima-ku

State/Province

Tokyo

ZIP/Postal Code

170-8476

Country

Japan

Facility Name

Novartis Investigative Site

City

Kaunas

State/Province

LTU

ZIP/Postal Code

LT 50161

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kota Kinabalu

State/Province

Sabah

ZIP/Postal Code

88996

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Kuala Lumpur

State/Province

Wilayah Persekutuan

ZIP/Postal Code

50586

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Brasov

ZIP/Postal Code

500025

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucuresti

ZIP/Postal Code

020395

Country

Romania

Facility Name

Novartis Investigative Site

City

Timisoara

ZIP/Postal Code

300041

Country

Romania

Facility Name

Novartis Investigative Site

City

Cheboksary

ZIP/Postal Code

428028

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kazan

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

127486

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint-Petersburg

ZIP/Postal Code

194100

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Riyadh

ZIP/Postal Code

11211

Country

Saudi Arabia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

833 40

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taoyuan

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Istanbul

State/Province

Bakirkoy

ZIP/Postal Code

34140

Country

Turkey

Facility Name

Novartis Investigative Site

City

Meselik

State/Province

Eskisehir

ZIP/Postal Code

26480

Country

Turkey

Facility Name

Novartis Investigative Site

City

Soguksu / Antalya

ZIP/Postal Code

07100

Country

Turkey

Facility Name

Novartis Investigative Site

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Portsmouth

ZIP/Postal Code

PO6 3LY

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Citations:

PubMed Identifier

34391532

Citation

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.

Results Reference

derived

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Rainbow Extension Study

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Rainbow Extension Study (RainbowExt)

Retinopathy of Prematurity (ROP)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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