Rainbow Extension Study

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

ClinicalTrials.gov Identifier: NCT02640664

Novartis Reference Number: CRFB002H2301E1

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this study is 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

Condition 
Retinopathy of Prematurity
Phase 
Phase 3
Overall status 
Active, not recruiting
Enrollment count 
180 participants
Start date 
Jun 16, 2016
Completion date 
Oct 31, 2022
Gender 
All
Age(s)
(Child, Adult, Older Adult)

Interventions

Drug
Ranibizumab
0.2 mg Intravitreal administration Up to 2 re-treatments in each eye 28 days minimum interval between 2 injections
Drug
Ranibizumab
0.1 mg Intravitreal administration Up to 2 re-treatments in each eye 28 days minimum interval between 2 injections

Eligibility Criteria

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

Study Locations

United States
Novartis Investigative Site
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Sacramento, 95817
California
United States
Novartis Investigative Site
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Aurora, 80045
Colorado
United States
Novartis Investigative Site
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Chicago, 60612
Illinois
United States
Novartis Investigative Site
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Louisville, 40202
Kentucky
United States
Novartis Investigative Site
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Baltimore, 21201
Maryland
United States
Novartis Investigative Site
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Ann Arbor, 48105
Michigan
United States
Novartis Investigative Site
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Rochester, 14642
New York
United States
Novartis Investigative Site
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Austin, 78705
Texas
United States
Novartis Investigative Site
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Morgantown, 26506
West Virginia
United States
Austria
Novartis Investigative Site
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Graz, A-8036
-
Austria
Novartis Investigative Site
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Vienna, 1090
-
Austria
Belgium
Novartis Investigative Site
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Brugge, 8000
-
Belgium
Novartis Investigative Site
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Gent, 9000
-
Belgium
Croatia
Novartis Investigative Site
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Zagreb, 10000
-
Croatia
Czechia
Novartis Investigative Site
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Ostrava Poruba, 708 52
Czech Republic
Czechia
Novartis Investigative Site
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Praha 4 - Podoli, 14700
Czech Republic
Czechia
Novartis Investigative Site
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Praha, 12808
-
Czechia
Denmark
Novartis Investigative Site
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Koebenhavn Ø, 2100
-
Denmark
Egypt
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Alexandria, 21131
-
Egypt
Estonia
Novartis Investigative Site
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Tallinn, 10138
-
Estonia
France
Novartis Investigative Site
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Amiens Cedex 1, 80054
-
France
Novartis Investigative Site
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Marseille, 13915
-
France
Germany
Novartis Investigative Site
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Hannover, 30625
-
Germany
Greece
Novartis Investigative Site
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Ampelokipi, 115 27
GR
Greece
Novartis Investigative Site
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Thessaloniki, 564 03
GR
Greece
Novartis Investigative Site
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Goudi-Athens, 115 27
-
Greece
Hungary
Novartis Investigative Site
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Budapest, 1125
-
Hungary
Novartis Investigative Site
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Debrecen, 4032
-
Hungary
India
Novartis Investigative Site
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Ahmedabad, 380016
Gujarat
India
Novartis Investigative Site
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Mumbai, 400 008
Maharashtra
India
Novartis Investigative Site
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Coimbatore, 641014
Tamil Nadu
India
Novartis Investigative Site
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Madurai, 625020
Tamil Nadu
India
Novartis Investigative Site
-
Vanchiyoor, 695035
Thiruvanantapuram
India
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New Delhi, 110029
-
India
Italy
Novartis Investigative Site
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Firenze, 50139
FI
Italy
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Roma, 00168
Lazio
Italy
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Perugia, 06100
PG
Italy
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Fiumicino, 00054
RM
Italy
Japan
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Nagoya, 453-8511
Aichi
Japan
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Nagoya, 466 8560
Aichi
Japan
Novartis Investigative Site
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Yachiyo-city, 276-8524
Chiba
Japan
Novartis Investigative Site
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Fukuoka city, 812-8582
Fukuoka
Japan
Novartis Investigative Site
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Fukuoka city, 814 0180
Fukuoka
Japan
Novartis Investigative Site
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Kurume city, 830-0011
Fukuoka
Japan
Novartis Investigative Site
-
Sapporo-city,
Hokkaido
Japan
Novartis Investigative Site
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Zentsuji-city, 765-8507
Kagawa
Japan
Novartis Investigative Site
-
Shimajiri-Gun, 901-1303
Okinawa
Japan
Novartis Investigative Site
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Izumi-city, 594-1101
Osaka
Japan
Novartis Investigative Site
-
Ohtsu-city, 520-2192
Shiga
Japan
Novartis Investigative Site
-
Fuchu-city, 183-8561
Tokyo
Japan
Novartis Investigative Site
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Ota-ku, 143 8541
Tokyo
Japan
Novartis Investigative Site
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Setagaya-ku, 157-8535
Tokyo
Japan
Novartis Investigative Site
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Sumida-ku, 130-8575
Tokyo
Japan
Novartis Investigative Site
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Toshima-ku, 170-8476
Tokyo
Japan
Lithuania
Novartis Investigative Site
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Kaunas, LT 50161
LTU
Lithuania
Malaysia
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Kota Kinabalu, 88996
Sabah
Malaysia
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Kuala Lumpur, 50586
Wilayah Persekutuan
Malaysia
Romania
Novartis Investigative Site
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Brasov, 500025
-
Romania
Novartis Investigative Site
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Bucuresti, 020395
-
Romania
Novartis Investigative Site
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Timisoara, 300041
-
Romania
Russian Federation
Novartis Investigative Site
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Cheboksary, 428028
-
Russian Federation
Novartis Investigative Site
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Kazan, 420012
-
Russian Federation
Novartis Investigative Site
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Moscow, 127486
-
Russian Federation
Novartis Investigative Site
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Saint-Petersburg, 194100
-
Russian Federation
Saudi Arabia
Novartis Investigative Site
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Riyadh, 11211
-
Saudi Arabia
Slovakia
Novartis Investigative Site
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Bratislava, 833 40
-
Slovakia
Taiwan
Novartis Investigative Site
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Taipei, 10002
-
Taiwan
Novartis Investigative Site
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Taoyuan, 33305
-
Taiwan
Turkey
Novartis Investigative Site
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Eskisehir, 26480
Meselik
Turkey
Novartis Investigative Site
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Istanbul, 34140
-
Turkey
Novartis Investigative Site
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Soguksu / Antalya, 07100
-
Turkey
United Kingdom
Novartis Investigative Site
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Manchester, M13 9WL
-
United Kingdom
Novartis Investigative Site
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Portsmouth, PO6 3LY
-
United Kingdom

Have a question?

Call 1-999-669-6682 or email [email protected]