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RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity (RAINBOW)

Primary Purpose

Retinopathy of Prematurity

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ranibizumab

Laser therapy

About this trial

This is an interventional treatment trial for Retinopathy of Prematurity focused on measuring intravitreal ranibizumab, laser ablation therapy, retinopathy of prematurity, preterm infants, RAINBOW

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

preterm infants with a birth weight of less than 1500 g
bilateral ROP with one of the following retinal findings in each eye: Zone I, stage 1+, 2+, 3 or 3+ disease, or Zone II, stage 3+ disease, or Aggressive posterior retinopathy of prematurity (AP-ROP)

Exclusion Criteria:

ROP disease characteristic in either eye other than that listed above at the time of the first investigational treatment
A history of hypersensitivity (either the patient or the mother) to any of the investigational treatments or to drugs of similar chemical classes
Had received any previous surgical or nonsurgical treatment for ROP (e.g., ablative laser therapy or cryotherapy, vitrectomy)
Had been previously exposed to any intravitreal or systemic anti-VEGF agent (either the patient or the mother during this child's pregnancy)
Had used (either the patient or the mother) other investigational drugs as part of another clinical study (other than vitamins and minerals) within 30 days or within 5 half-lives of the other investigational drug, whichever was longer
Had ocular structural abnormalities that were assessed by the Investigator to have had a clinically significant impact on study assessments
Had active ocular infection within 5 days before or on the day of first investigational treatment
Had a history of hydrocephalus requiring treatment
Had a history of any other neurological conditions that are assessed by the Investigator to have a significant risk of severe impact on visual function
Had any other medical conditions or clinically significant comorbidities or personal circumstances that were assessed by the Investigator to have a clinically relevant impact on study participation, any of the study procedures, or on efficacy assessments (e.g., poor life expectancy, pupil not able to be adequately dilated, unable to comply with the visit schedule)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

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 treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed

Outcomes

Primary Outcome Measures

Percentage of Participants With Absence of Active ROP and Absence of Unfavorable Structural Outcomes in Both Eyes at Week 24

To achieve this outcome, patients must fulfill all the following criteria, 1) survival, 2) no intervention with a second modality for ROP, 3) absence of active ROP and 4) absence of unfavorable structural outcome. Retinopathy of prematurity (ROP) is a pathologic process that occurs in the incompletely vascularized, developing retina of low birth-weight preterm neonates.

Secondary Outcome Measures

Percentage of Participants Requiring Interventions With a Second Modality for ROP at Week 24

Intervention for ROP in either eye at or before the 24-week assessment visit with a treatment modality other than the modality of the first study treatment. Only descriptive analysis done.

Number of Participants Experiencing an Event, From the First Study Treatment to the Last Study Visit

An event was defined as death, treatment switch, or the first occurrence of unfavorable structural outcomes in either eye. Only descriptive analysis done.

Percentage of Participants Having Recurrent ROP and Receiving Any Post-baseline Intervention at or Before Week 24

Recurrence of ROP is defined as subjects receiving any post-baseline intervention in either eye at or before 24 weeks (ranibizumab re-treatment or switch to laser in the ranibizumab groups, switch to ranibizumab treatment in the laser group). Zone I consists of a circle, the radius of which extends from the center of the optic disc to twice the distance from the center of the optic disc to the center of the macula. Zone II extends centrifugally from the edge of zone I to the nasal ora serrata. Only descriptive analysis done.

Percent of Participants With Ocular Adverse Events by Primary System Organ (SOCs) at Week 24

Percent of Participants with Ocular Adverse Events regardless of Study Treatment and Procedure Relationship by Primary System Organ (SOCs) reported categorically (Mild, Moderate, Severe) 24 weeks after the first study treatment. Only descriptive analysis done.

Mean Change in Ranibizumab Concentration in Pharmacokinetic Serum Samples Over Time at Day 1, Day 15 and Day 29

Blood samples for the determination of ranibizumab concentrations were collected in the Ranibizumab treatment arms only at the following time points: within 24 hours after the first administration of ranibizumab, at Day 15 and at Day 29. Only descriptive analysis done.

Mean Change in Vascular Endothelial Growth Factor (VEGF) Levels Over Time at Day 1, Day 15 and Day 29

Blood samples for the determination of systemic VEGF levels were collected at the following time points: before the first investigational treatment, at Day 15 and at Day 29. Only descriptive analysis done.

Total Number of Ranibizumab Injections Received at Week 24

Patients randomized to receive Ranibizumab 0.1 mg or 0.2 mg received a single dose of intravitreal Ranibizumab to each eye on Day 1 (Baseline). Only descriptive analysis done.

Percent of Participants With Non-Ocular Adverse Events by Primary System Organ (SOCs) at Week 24

Percent of Participants with Non-Ocular Adverse Events regardless of Study Treatment and Procedure Relationship by Primary System Organ (SOCs) reported categorically (Mild, Moderate, Severe) 24 weeks after the first study treatment. Only descriptive analysis done.

Mean Change From Baseline in Vital Signs (Body Length, Head Circumference and Knee to Heel Length) at Day 85 and Day 169

Body Length, Head Circumference and Knee to Heel Length were assessed. Only descriptive analysis done.

Mean Change From Baseline in Vital Signs (Weight) at Day 85 and Day 169

Body weight was measured. Only descriptive analysis done.

Mean Change From Baseline in Vital Signs (Sitting Blood Pressure) at Day 85 and Day 169

Blood Pressure measurements were not required by the protocol. Instead, the most recent Systolic and Diastolic Blood Pressure expressed in millimeters of mercury (mmHg) measured as part of the routine clinical care were used. Only descriptive analysis done.

Full Information

NCT ID

NCT02375971

First Posted

February 18, 2015

Last Updated

October 15, 2018

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02375971

Brief Title

RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity

Acronym

RAINBOW

Official Title

RAINBOW Study: a Randomized, Controlled Study Evaluating the 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

October 2018

Overall Recruitment Status

Completed

Study Start Date

December 30, 2015 (Actual)

Primary Completion Date

December 14, 2017 (Actual)

Study Completion Date

December 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study was to determine if intravitreal ranibizumab is superior to laser ablation therapy in the treatment of retinopathy of prematurity (ROP).

Detailed Description

The study consisted of a screening period (screening and randomization could occur up to 3 days before the administration of the first investigational treatment), followed by a treatment and follow-up period (Day 1 to Day 169).

6. Conditions and Keywords

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

Retinopathy of Prematurity

Keywords

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

Randomized

Enrollment

224 (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

Active Comparator

Arm Description

Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed

Intervention Type

Drug

Intervention Name(s)

Ranibizumab

Intervention Description

Administered as an intravitreal injection

Intervention Type

Procedure

Intervention Name(s)

Laser therapy

Intervention Description

Transpupillary diode or frequency-doubled yttrium aluminum garnet (YAG) laser ablative therapy, following anesthesia or sedation

Primary Outcome Measure Information:

Title

Percentage of Participants With Absence of Active ROP and Absence of Unfavorable Structural Outcomes in Both Eyes at Week 24

Description

Time Frame

Week 24

Secondary Outcome Measure Information:

Title

Percentage of Participants Requiring Interventions With a Second Modality for ROP at Week 24

Description

Intervention for ROP in either eye at or before the 24-week assessment visit with a treatment modality other than the modality of the first study treatment. Only descriptive analysis done.

Time Frame

Week 24

Title

Number of Participants Experiencing an Event, From the First Study Treatment to the Last Study Visit

Description

An event was defined as death, treatment switch, or the first occurrence of unfavorable structural outcomes in either eye. Only descriptive analysis done.

Time Frame

Day 1 (after initiation of study treatment) up to study exit (Day 169)

Title

Percentage of Participants Having Recurrent ROP and Receiving Any Post-baseline Intervention at or Before Week 24

Description

Time Frame

Week 24

Title

Percent of Participants With Ocular Adverse Events by Primary System Organ (SOCs) at Week 24

Description

Time Frame

Week 24

Title

Mean Change in Ranibizumab Concentration in Pharmacokinetic Serum Samples Over Time at Day 1, Day 15 and Day 29

Description

Time Frame

Day 1 (Baseline), Day 15 and Day 29

Title

Mean Change in Vascular Endothelial Growth Factor (VEGF) Levels Over Time at Day 1, Day 15 and Day 29

Description

Time Frame

Day 1 (Baseline), Day 15 and Day 29

Title

Total Number of Ranibizumab Injections Received at Week 24

Description

Patients randomized to receive Ranibizumab 0.1 mg or 0.2 mg received a single dose of intravitreal Ranibizumab to each eye on Day 1 (Baseline). Only descriptive analysis done.

Time Frame

Week 24

Title

Percent of Participants With Non-Ocular Adverse Events by Primary System Organ (SOCs) at Week 24

Description

Time Frame

Week 24

Title

Mean Change From Baseline in Vital Signs (Body Length, Head Circumference and Knee to Heel Length) at Day 85 and Day 169

Description

Body Length, Head Circumference and Knee to Heel Length were assessed. Only descriptive analysis done.

Time Frame

Baseline, Day 85, Day 169

Title

Mean Change From Baseline in Vital Signs (Weight) at Day 85 and Day 169

Description

Body weight was measured. Only descriptive analysis done.

Time Frame

Baseline, Day 85, Day 169

Title

Mean Change From Baseline in Vital Signs (Sitting Blood Pressure) at Day 85 and Day 169

Description

Time Frame

Baseline, Day 85, Day 169

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: preterm infants with a birth weight of less than 1500 g bilateral ROP with one of the following retinal findings in each eye: Zone I, stage 1+, 2+, 3 or 3+ disease, or Zone II, stage 3+ disease, or Aggressive posterior retinopathy of prematurity (AP-ROP) Exclusion Criteria: ROP disease characteristic in either eye other than that listed above at the time of the first investigational treatment A history of hypersensitivity (either the patient or the mother) to any of the investigational treatments or to drugs of similar chemical classes Had received any previous surgical or nonsurgical treatment for ROP (e.g., ablative laser therapy or cryotherapy, vitrectomy) Had been previously exposed to any intravitreal or systemic anti-VEGF agent (either the patient or the mother during this child's pregnancy) Had used (either the patient or the mother) other investigational drugs as part of another clinical study (other than vitamins and minerals) within 30 days or within 5 half-lives of the other investigational drug, whichever was longer Had ocular structural abnormalities that were assessed by the Investigator to have had a clinically significant impact on study assessments Had active ocular infection within 5 days before or on the day of first investigational treatment Had a history of hydrocephalus requiring treatment Had a history of any other neurological conditions that are assessed by the Investigator to have a significant risk of severe impact on visual function Had any other medical conditions or clinically significant comorbidities or personal circumstances that were assessed by the Investigator to have a clinically relevant impact on study participation, any of the study procedures, or on efficacy assessments (e.g., poor life expectancy, pupil not able to be adequately dilated, unable to comply with the visit schedule)

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

Loma Linda

State/Province

California

ZIP/Postal Code

92354

Country

United States

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

40208

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

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

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

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

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

Osijek

ZIP/Postal Code

31000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Ostrava Poruba

State/Province

Czech Republic

ZIP/Postal Code

708 52

Country

Czechia

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

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

13419

Country

Estonia

Facility Name

Novartis Investigative Site

City

Amiens Cedex 1

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

Bonn

ZIP/Postal Code

53127

Country

Germany

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

546 29

Country

Greece

Facility Name

Novartis Investigative Site

City

Goudi- 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

Roma

State/Province

Lazio

ZIP/Postal Code

00168

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

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

Fukushima-city

State/Province

Fukushima

ZIP/Postal Code

960-1295

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

Querataro

ZIP/Postal Code

76090

Country

Mexico

Facility Name

Novartis Investigative Site

City

Bialystok

ZIP/Postal Code

15-274

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

51-124

Country

Poland

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

Eskisehir

State/Province

Meselik

ZIP/Postal Code

26480

Country

Turkey

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06500

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34140

Country

Turkey

Facility Name

Novartis Investigative Site

City

Soguksu / Antalya

ZIP/Postal Code

07100

Country

Turkey

Facility Name

Novartis Investigative Site

City

Zuhuratbaba / Istanbul

ZIP/Postal Code

34147

Country

Turkey

Facility Name

Novartis Investigative Site

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Oxford

ZIP/Postal Code

OX3 9DU

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

Undecided

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

35202890

Citation

Fleck BW, Reynolds JD, Zhu Q, Lepore D, Marlow N, Stahl A, Li J, Weisberger A, Fielder AR; RAINBOW Investigator Group. Time Course of Retinopathy of Prematurity Regression and Reactivation After Treatment with Ranibizumab or Laser in the RAINBOW Trial. Ophthalmol Retina. 2022 Jul;6(7):628-637. doi: 10.1016/j.oret.2022.02.006. Epub 2022 Feb 22.

Results Reference

derived

PubMed Identifier

31522845

Citation

Stahl A, Lepore D, Fielder A, Fleck B, Reynolds JD, Chiang MF, Li J, Liew M, Maier R, Zhu Q, Marlow N. Ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW): an open-label randomised controlled trial. Lancet. 2019 Oct 26;394(10208):1551-1559. doi: 10.1016/S0140-6736(19)31344-3. Epub 2019 Sep 12.

Results Reference

derived

Learn more about this trial

RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity

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RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity (RAINBOW)

Retinopathy of Prematurity

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

Learn more about this trial