RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity
NCT ID: NCT02375971
Last Updated: 2018-11-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
224 participants
INTERVENTIONAL
2015-12-30
2017-12-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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
Ranibizumab
Administered as an intravitreal injection
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
Ranibizumab
Administered as an intravitreal injection
Laser therapy
Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed
Laser therapy
Transpupillary diode or frequency-doubled yttrium aluminum garnet (YAG) laser ablative therapy, following anesthesia or sedation
Interventions
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Ranibizumab
Administered as an intravitreal injection
Laser therapy
Transpupillary diode or frequency-doubled yttrium aluminum garnet (YAG) laser ablative therapy, following anesthesia or sedation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Loma Linda, California, United States
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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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Boston, Massachusetts, 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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Salt Lake City, Utah, 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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Osijek, , Croatia
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Zagreb, , Croatia
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Ostrava Poruba, Czech Republic, Czechia
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Praha 4 - Podoli, Czech Republic, 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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Bonn, , Germany
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Hanover, , Germany
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Ampelokipoi, GR, Greece
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Thessaloniki, GR, Greece
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Goudi- 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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Rome, Lazio, Italy
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Perugia, PG, Italy
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Fiumicino, 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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Fukushima, Fukushima, 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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Querataro, , Mexico
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Bialystok, , Poland
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Wroclaw, , Poland
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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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Eskişehir, Meselik, Turkey (Türkiye)
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Soguksu / Antalya, Turkey, Turkey (Türkiye)
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Zuhuratbaba / Istanbul, Turkey, Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Manchester, , United Kingdom
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Oxford, , United Kingdom
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Portsmouth, , United Kingdom
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2014-003041-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRFB002H2301
Identifier Type: -
Identifier Source: org_study_id
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