Ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW): five-year outcomes of a randomised trialResearch in context
Summary: Background: Concerns remain over the long-term safety of vascular endothelial growth factor (VEGF) inhibitors to treat retinopathy of prematurity (ROP). RAINBOW is an open label randomised trial comparing intravitreal ranibizumab (in 0.2 mg and 0.1 mg doses) with laser therapy in very low...
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| Format: | Article |
| Language: | English |
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Elsevier
2024-05-01
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| Series: | EClinicalMedicine |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2589537024001469 |
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| author | Neil Marlow James D. Reynolds Domenico Lepore Alistair R. Fielder Andreas Stahl Han Hao Annemarie Weisberger Amit Lodha Brian W. Fleck |
| author_facet | Neil Marlow James D. Reynolds Domenico Lepore Alistair R. Fielder Andreas Stahl Han Hao Annemarie Weisberger Amit Lodha Brian W. Fleck |
| author_sort | Neil Marlow |
| collection | DOAJ |
| description | Summary: Background: Concerns remain over the long-term safety of vascular endothelial growth factor (VEGF) inhibitors to treat retinopathy of prematurity (ROP). RAINBOW is an open label randomised trial comparing intravitreal ranibizumab (in 0.2 mg and 0.1 mg doses) with laser therapy in very low birthweight infants (<1500 g) with ROP. Methods: Of 201 infants completing RAINBOW, 180 were enrolled in the RAINBOW Extension Study. At 5 years, children underwent ophthalmic, development and health assessments. The primary outcome was visual acuity in the better-seeing eye. The study is registered with ClinicalTrial.gov, NCT02640664. Findings: Between 16-6-2016 and 21-4-2022, 156 children (87%) were evaluated at 5 years. Of 32 children with no acuity test result, 25 had a preferential looking test, for 4 children investigators reported low vision for each eye, and in 3 further children no vision measurement was obtained. 124 children completed the acuity assessment, the least square mean (95% CI) letter score in the better seeing eye was similar in the three trial arms—66.8 (62.9–70.7) following ranibizumab 0.2 mg, 64.6 (60.6–68.5) following ranibizumab 0.1 mg and 62.1 (57.8–66.4) following laser therapy; differences in means: ranibizumab 0.2 mg v laser: 4.7 (95% CI: −1.1, 10.5); 0.1 mg v laser: 2.5 (−3.4, 8.3); 0.2 mg v 0.1 mg: 2.2 (−3.3, 7.8). High myopia (worse than −5 dioptres) in at least one eye occurred in 4/52 (8%) children following ranibizumab 0.2 mg, 8/55 (15%) following ranibizumab 0.1 mg and 11/45 (24%) following laser therapy (0.2 mg versus laser: odds ratio: 3.99 (1.16–13.72)). Ocular and systemic secondary outcomes and adverse events were distributed similarly in each trial arm. Interpretation: 5-year outcomes confirm the findings of the original RAINBOW trial and a planned interim analysis at 2 years, including a reduced frequency of high myopia following ranibizumab treatment. No effects of treatment on non-ocular outcomes were detected. Funding: Novartis Pharma AG. |
| first_indexed | 2024-04-24T10:04:29Z |
| format | Article |
| id | doaj.art-bd57c7c08cf64cf390d072add40bfad0 |
| institution | Directory Open Access Journal |
| issn | 2589-5370 |
| language | English |
| last_indexed | 2024-04-24T10:04:29Z |
| publishDate | 2024-05-01 |
| publisher | Elsevier |
| record_format | Article |
| series | EClinicalMedicine |
| spelling | doaj.art-bd57c7c08cf64cf390d072add40bfad02024-04-13T04:21:39ZengElsevierEClinicalMedicine2589-53702024-05-0171102567Ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW): five-year outcomes of a randomised trialResearch in contextNeil Marlow0James D. Reynolds1Domenico Lepore2Alistair R. Fielder3Andreas Stahl4Han Hao5Annemarie Weisberger6Amit Lodha7Brian W. Fleck8UCL Elizabeth Garrett Anderson Institute for Women's Health, University College London, London, UK; Corresponding author. UCL Elizabeth Garrett Anderson Institute for Women's Health, 74 Huntley Street, London, WC1E 6AU, UK.Ross Eye Institute, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, USADepartment of Neuroscience, Sensory Organs and Thorax, Catholic University of the Sacred Heart, Gemelli Foundation IRCSS, Rome, ItalyDepartment of Optometry & Visual Science, City, University of London, UKDepartment of Ophthalmology, University Medical Center Greifswald, GermanyChina Novartis Institutes for BioMedical Research Company LtdNovartis Pharma AG, Basel, SwitzerlandNovartis Pharmaceuticals Corporation, East Hanover, NJ, USACentre for Clinical Brain Sciences, University of Edinburgh, UKSummary: Background: Concerns remain over the long-term safety of vascular endothelial growth factor (VEGF) inhibitors to treat retinopathy of prematurity (ROP). RAINBOW is an open label randomised trial comparing intravitreal ranibizumab (in 0.2 mg and 0.1 mg doses) with laser therapy in very low birthweight infants (<1500 g) with ROP. Methods: Of 201 infants completing RAINBOW, 180 were enrolled in the RAINBOW Extension Study. At 5 years, children underwent ophthalmic, development and health assessments. The primary outcome was visual acuity in the better-seeing eye. The study is registered with ClinicalTrial.gov, NCT02640664. Findings: Between 16-6-2016 and 21-4-2022, 156 children (87%) were evaluated at 5 years. Of 32 children with no acuity test result, 25 had a preferential looking test, for 4 children investigators reported low vision for each eye, and in 3 further children no vision measurement was obtained. 124 children completed the acuity assessment, the least square mean (95% CI) letter score in the better seeing eye was similar in the three trial arms—66.8 (62.9–70.7) following ranibizumab 0.2 mg, 64.6 (60.6–68.5) following ranibizumab 0.1 mg and 62.1 (57.8–66.4) following laser therapy; differences in means: ranibizumab 0.2 mg v laser: 4.7 (95% CI: −1.1, 10.5); 0.1 mg v laser: 2.5 (−3.4, 8.3); 0.2 mg v 0.1 mg: 2.2 (−3.3, 7.8). High myopia (worse than −5 dioptres) in at least one eye occurred in 4/52 (8%) children following ranibizumab 0.2 mg, 8/55 (15%) following ranibizumab 0.1 mg and 11/45 (24%) following laser therapy (0.2 mg versus laser: odds ratio: 3.99 (1.16–13.72)). Ocular and systemic secondary outcomes and adverse events were distributed similarly in each trial arm. Interpretation: 5-year outcomes confirm the findings of the original RAINBOW trial and a planned interim analysis at 2 years, including a reduced frequency of high myopia following ranibizumab treatment. No effects of treatment on non-ocular outcomes were detected. Funding: Novartis Pharma AG.http://www.sciencedirect.com/science/article/pii/S2589537024001469InfantPretermRetinopathy of prematurityAnti-VEGF treatmentRandomised controlled trialNeurodevelopment |
| spellingShingle | Neil Marlow James D. Reynolds Domenico Lepore Alistair R. Fielder Andreas Stahl Han Hao Annemarie Weisberger Amit Lodha Brian W. Fleck Ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW): five-year outcomes of a randomised trialResearch in context EClinicalMedicine Infant Preterm Retinopathy of prematurity Anti-VEGF treatment Randomised controlled trial Neurodevelopment |
| title | Ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW): five-year outcomes of a randomised trialResearch in context |
| title_full | Ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW): five-year outcomes of a randomised trialResearch in context |
| title_fullStr | Ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW): five-year outcomes of a randomised trialResearch in context |
| title_full_unstemmed | Ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW): five-year outcomes of a randomised trialResearch in context |
| title_short | Ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW): five-year outcomes of a randomised trialResearch in context |
| title_sort | ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity rainbow five year outcomes of a randomised trialresearch in context |
| topic | Infant Preterm Retinopathy of prematurity Anti-VEGF treatment Randomised controlled trial Neurodevelopment |
| url | http://www.sciencedirect.com/science/article/pii/S2589537024001469 |
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