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A noninterventional study to monitor patients with diabetic macular oedema starting treatment with ranibizumab (POLARIS)
Author(s) -
Stefanickova Jana,
CunhaVaz Jose,
Ulbig Michael,
Pearce Ian,
FernándezVega Sanz Alvaro,
Theodossiadis Panagiotis,
Kodjikian Laurent,
Izmailov Alexander,
Muston Dominic,
Vassilev Zdravko,
Lamotte Benedicte,
Tückmantel Claudia,
Friedl Sabine,
Altemark Andreas,
Schwarz HansJörg,
Katz Todd
Publication year - 2018
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.13771
Subject(s) - medicine , visual acuity , ranibizumab , ophthalmology , confidence interval , optometry , surgery , bevacizumab , chemotherapy
Purpose Antivascular endothelial growth factor agents are increasingly used in diabetic macular oedema (DME); however, there are few studies exploring their use in DME in real‐world settings. Methods POLARIS was a noninterventional, multicentre study to monitor 12‐month outcomes in patients starting ranibizumab treatment in routine practices. The primary outcome was mean change in visual acuity (VA) from baseline to month 12 (last observation carried forward approach). Other outcomes included mean change in central retinal thickness (CRT) and resource utilization. Visual acuity (VA) outcomes were also stratified by country, baseline visual acuity score (VAS), sex, age and injection frequency. Results Outcomes were analysed from all treated patients ( n = 804) and from first‐year completers (patients who had a visual acuity assessment at 12 months; n = 568). The mean (SD) baseline VAS was 59.4 (15.9) letters, and the mean change in visual acuity was 4.4 letters (95% confidence interval: 3.3–5.4) at month 12 (study eye; first‐year completers). The mean number of injections (study eye) was 4.9, and the mean number of all visits (any eye) was 10 (58% were injection visits) over 12 months (first‐year completers). The mean (SD) baseline CRT was 410.6 (128.8) μ m, and the mean change in CRT was −115.2 μ m at month 12 (study eye; first‐year completers). Visual acuity (VA) outcomes were generally comparable across most countries and subgroups and were greatest in patients with the lowest baseline VAS (≤60 letters). Conclusion POLARIS showed that real‐world outcomes in DME patients starting treatment with ranibizumab were lower than those observed in clinical studies, in spite of extensive monitoring.