A real-world study looking into the effectiveness of ranibizumab found a majority of DME patients showed significant improvement in VA and central retinal thickness. The investigation, sponsored by Novartis, also reported a reduction in infections and injections in the subsequent years following treatment. Overall, injections decreased from an average of 5.2 in year one to 0.8 in year five. BCVA gains over baseline included a mean of +5.3 letters at year one, +8.9 at year two and +5.8 at year three.
The study, known as VISION, included a small sampling of 55 DME patients treated with 0.5mg ranibizumab. The participants were followed for at least 36 months. Of all the study eyes, 22% were treatment-naïve, 9% had prior anti-VEGF treatment and 64% had undergone other previous treatments.
In the first year, treatment-naïve patients had 5.1±3.0 injections compared with 4.5±2.7 in the previous anti-VEGF treatment group and 5.6±3.1 in the prior other treatment group.
At 12 months, BCVA increased by 8.9±16.4 letters from 59.7±9.3 at baseline in the treatment-naïve group. The previous anti-VEGF treatment eyes experienced an increase of 11.8±9.9 letters from 61.6±8.5, and eyes that underwent other earlier treatments added 4.2±10.6 letters from a baseline of 58.2±14.6. BCVA remained stable for the remainder of follow-up in each group.
Central retinal thickness decreased over the first two months by monthly rates of -43.8µm in treatment-naïve eyes, -75.7µm in prior anti-VEGF eyes and -65.8µm in eyes that underwent other previous treatments, with all groups showing stability afterward.
The researchers reported no adverse events, except for a painful eye following injection possibly due to treatment.
Despite the successful results, the data revealed the BCVA and central retinal thickness outcomes were less favorable than those found in early efficacy trials, which the investigators attributed to lower treatment intensities.
VISION is among the first studies to report long-term, real-world clinical data in DME patients treated with ranibizumab and will hopefully give way to more breakthrough research, the study authors concluded in their paper.
Van Aken E, Favreau M, Ramboer E, et al. Real-world outcomes in patients with diabetic macular edema treated long term with ranibizumab (VISION Study). Clin Ophthalmol. 2020;14:4173-85.