Trial reportBMJ open ophthalmology2025
Different ranibizumab dosages for retinopathy of prematurity: 5-year follow-up data of the randomised, controlled CARE-ROP Study.
Trial report in BMJ open ophthalmology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundData on long-term outcomes of antivascular endothelial growth factor therapy in retinopathy of prematurity (ROP) are still rare. We present 5-year post-treatment ophthalmological and paediatric outcomes of the prospective, multicentre, randomised, double-blinded, controlled pilot study CARE-ROP (Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity).
methods14 patients (28 eyes) completed the ophthalmologic and 5 patients completed the paediatric 5-year follow-up assessment. The ophthalmological assessment included best-corrected visual acuity (BCVA), orthoptic status, slit lamp examination, intraocular pressure and funduscopy. The paediatric examination followed the German Neonatal Network protocol and covered cognitive, motor and sensory development.
results17 of 28 eyes exhibited at least one ocular abnormality, such as optic disc pallor or atrophy of the optic nerve head, retinal pigment epithelium (RPE) pigment changes, persistent tortuosity or macular hypoplasia. Despite this, 19 of 26 eyes demonstrated a logarithm of the Minimum Angle of Resolution (logMAR) BCVA of 0.3 or better. Mean refractive error was -0.9 D (±3.4 D) with only two eyes of one infant having high myopia of < -5 D. The neurodevelopmental results were within the expected range for a population of preterm infants with treatment-warranting ROP but need to be interpreted with caution due to the low number of five patients.
conclusionThe 5-year ophthalmologic and paediatric outcomes of the CARE-ROP study confirm the previous results and add important additional information on long-term safety of 0.12 and 0.20 mg ranibizumab for the treatment of ROP. The ophthalmologic functional outcome regarding BCVA and refraction is promising. These exploratory long-term data, however, need to be interpreted with caution due to the low patient number both in the ophthalmologic and paediatric assessment.
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