drugset / Trial / NCT02640664
Rainbow Extension Study
Non-randomizedParallel-groupOpen-labelTreatment
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)
Timeline
- Start
- 2016-06-16
- Primary completion
- 2022-04-21
- Completion
- 2022-04-21
Publications
- Marlow N, Reynolds JD, Lepore D, Fielder AR, Stahl A, Hao H, Weisberger A, Lodha A, Fleck BW. Ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW): five-year outcomes of a randomised trial. EClinicalMedicine. 2024 Apr 11;71:102567. doi: 10.1016/j.eclinm.2024.102567. eCollection 2024 May.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ranibizumab | Monoclonal antibody | 0.1 mg | Intravitreal |
| Subject | Ranibizumab | Monoclonal antibody | 0.2 mg | Intravitreal |