Clinical Trials in ROP
Retinopathy of prematurity (ROP) affects the developing retina, with approximately 28,300 to 45,600 infants diagnosed globally each year. [Stahl.Lancet.2019] Low birth weight and low gestational age are major risk factors for ROP. [Mirghorbani M.Int J Vitreous Retina.2022] Although mild ROP may resolve on its own, severe ROP can lead to retinal detachment, vision impairment, and blindness. [Stahl.Lancet.2019] Treatments for ROP include lasers, anti-vascular endothelial growth factor (VEGF) injections, and ocular surgery. Laser treatment has been available longer than anti-VEGF injections; the long-term risks associated with laser therapy include visual field loss and high myopia. Concerns with anti-VEGF injections include potential systemic exposure to anti-VEGF agents and a higher risk for recurrent ROP compared with laser treatment. [Mirghorbani M.Int J Vitreous Retina.2022]
Click on the study name to see more details about each particular study. To enhance visibility of graphs and tables, click on the image to enlarge for expanding viewing.
References
Beck KD, Rahman EZ, Ells A, et al. SAFER-ROP: Updated Protocol for Anti-VEGF Injections for Retinopathy of Prematurity. OSLI Retina. 2020;51:402-406. https://journals.healio.com/doi/10.3928/23258160-20200702-05
Cryotherapy for Retinopathy of Prematurity Cooperative Group. Multicenter trial of cryotherapy for retinopathy of prematurity: Preliminary results. Pediatrics. 1988;81: 697-706. https://publications.aap.org/pediatrics/article-abstract/81/5/697/55219/Multicenter-Trial-of-Cryotherapy-for-Retinopathy
Cryotherapy for Retinopathy of Prematurity Cooperative Group. 15-Year Outcomes Following Threshold Retinopathy of Prematurity. Final Results From the Multicenter Trial of Cryotherapy for Retinopathy of Prematurity. Arch Ophthalmol. 2005;123:311-318. https://jamanetwork.com/journals/jamaophthalmology/article-abstract/416903
Good WV; Early Treatment for Retinopathy of Prematurity Cooperative Group. Final results of the Early Treatment of Retinopathy of Prematurity (ETROP) randomized trial. Trans Am Ophthalmol Soc. 2004;102:233-250. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1280104/
Mintz-Hittner HA, Kennedy KA, Chuang AZ for the BEAT-ROP Cooperative Group. Efficacy of intravitreal bevacizumab for stage 3+ of retinopathy of prematurity. N Engl J Med. 2011;364:603-615. https://www.nejm.org/doi/full/10.1056/NEJMoa1007374
Mirghorbani M, Rashidinia A, Yaseri M, et al. Progression of retinal vascularization after intravitreal anti-vascular-endothelial growth factor therapy in retinopathy of prematurity. Int J Vitreous Retina. 2022;8:13. https://journalretinavitreous.biomedcentral.com/articles/10.1186/s40942-022-00364-6
Stahl A, Lepore D, Fielder A, et al. Ranibizumab Versus Laser for the Treatment of Very Low Birthweight Infants With Retinopathy of Prematurity (RAINBOW): An Open-Label Randomised Controlled Trial. Lancet. 2019;394:1551-1559. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)31344-3/fulltext
Stahl A, Sukgen EA, Wu WC, et al. Effect of Intravitreal Aflibercept vs Laser Photocoagulation on Treatment Success of Retinopathy of Prematurity: The FIREFLEYE Randomized Clinical Trial. JAMA. 2022;328:348-359. https://jamanetwork.com/journals/jama/fullarticle/2794566
- Aflibercept for Retinopathy of Prematurity – Intravitreal Injection Versus Laser Therapy (FIREFLEYE). Clinicaltrials.gov identifier: NCT04004208. Last updated May 6, 2022. https://clinicaltrials.gov/study/NCT04004208
- Borzi A. Exploring an interdisciplinary support model for ROP exams in the NICU. Poster Abstract – NIDCAP TRAINERS MEETING 2024. Developmental Observer. 2025;18. https://scholarworks.iu.edu/journals/index.php/do/article/view/40893
- Maitra P, Jaju S, Agrawal KU, A, et al. Comparing safety and efficacy of bevacizumab, ranibizumab and ranibizumab biosimilar in retinopathy of prematurity. Eye (Lond). Published online February 7, 2025. https://doi.org/10.1038/s41433-025-03735-z
- Mirghorbani M, Rashidinia A, Yaseri M, et al. Progression of retinal vascularization after intravitreal anti-vascular-endothelial growth factor therapy in retinopathy of prematurity. Int J Retina Vitreous. 2022;8:13.
- Stahl A, Azuma N, Wu WC, et al. Systemic exposure to aflibercept after intravitreal injection in premature neonates with retinopathy of prematurity: Results from the FIREFLEYE randomized phase 3 study. Eye (Lond). 2024;38:1444-1453. https://www.nature.com/articles/s41433-023-02919-9
- Stahl A, Lepore D, Fielder A, et al. 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;394:1551-1559. https://www.sciencedirect.com/science/article/abs/pii/S0140673619313443
All URLs accessed April 10, 2025
