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Intravitreal ranibizumab for persistent diabetic vitreous haemorrhage: a randomised, double‐masked, placebo‐controlled feasibility study.
Author(s) -
Petrarca Robert,
Soare Cristina,
Wong Roger,
Desai Riti,
Neffendorf James,
Simpson Andrew,
Jackson Timothy L.
Publication year - 2020
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/aos.14282
Subject(s) - medicine , vitrectomy , ranibizumab , pars plana , placebo , ophthalmology , visual acuity , confidence interval , randomized controlled trial , surgery , chemotherapy , bevacizumab , alternative medicine , pathology
Purpose To determine the feasibility of a definitive study of intravitreal ranibizumab to promote the clearance of persistent diabetic vitreous haemorrhage and thereby avoid vitrectomy. Methods This randomised, double‐masked, placebo‐controlled feasibility study recruited 24 participants with persistent diabetic vitreous haemorrhage listed for pars plana vitrectomy. Participants were randomised to a single 0.5‐mg intravitreal ranibizumab injection or a single subconjunctival saline injection. The primary outcome measure was the number of participants requiring pars plana vitrectomy at week 7. Results Eight of 12 participants (66.7%) in the ranibizumab group required vitrectomy at week 7 versus 12 of 12 (100%) in the placebo group (absolute risk reduction 33.3%, 95% confidence interval 2.1–70.7%; p = 0.09). One additional eye in the ranibizumab group required vitrectomy by 12 months. Mean visual acuity letter score at 12 months was 72.7 ± 12.3 in the ranibizumab group and 75.1 ± 10.1 in the placebo group. Safety was similar across groups. Conclusion Intravitreal ranibizumab may reduce the likelihood of proceeding to vitrectomy in patients with persistent, dense diabetic vitreous haemorrhage. Further studies appear feasible and justified.