Dr Rishi Singh reports on the pooled data from the VISTA and VIVID clinical trials on the use of intravitreal aflibercept injections (IAI) to treat diabetic macular oedema at the ASRS 39th Annual Scientific Meeting.
Reviewed by Dr Rishi P. Singh.
The pooled data from the VISTA and VIVID clinical trials on the use of intravitreal aflibercept injections (IAI) (Eylea, Regeneron Pharmaceuticals) to treat diabetic macular oedema (DMO) identified thicker central subfield thickness (CST) and better best-corrected visual acuity (BCVA) as baseline factors associated with a longer time to and lower rate of resolution of DMO.
Dr Rishi P. Singh, Dr Carolina Valentim and Dr Katherine Talcott reported the study results on behalf of the VISTA and VIVID study investigators. The coauthors are from the Center for Ophthalmic Bioinformatics, Cole Eye Institute, Cleveland Clinic, Cleveland.
These studies were multicentre, double-masked trials that included patients with clinically significant DMO with central macular involvement and BCVAs ranging from 20/40 to 20/320. Patients were randomized to 1 of 2 dosing intervals of the study treatment or laser.
The results showed that IAI significantly improved the visual and anatomic outcomes compared with laser after 52 weeks, and these results were maintained out to 100 weeks.
As with any disease, one of the first questions always concerns its resolution. “Predicting the estimated time to DMO resolution would set expectations about the initial treatment strategy for clinicians and patients. Since the clinical responses to DMO treatment may vary, identifying baseline factors associated with the time to DMO resolution may help set expectations for clinicians and patients during the initial treatment period,” Dr Singh commented.
To identify these factors, he and his colleague looked at how the baseline patient characteristics affected the time to DMO resolution in patients treated with IAI or laser in the 2 trials.
The investigators combined the demographic, systemic, and ocular characteristic data from the VISTA/VIVID patients treated with IAI, which included age, sex, race, ethnicity, diabetes type and duration, hemoglobin A1c, hypertension, hyperlipidemia, and smoking status. Eyes were included that had a baseline CST of 290 microns or greater and a baseline gradable diabetic retinopathy severity score (DRSS).
Ultimately, 832 eyes from the 2 studies satisfied the inclusion criteria. For the analysis based on the DRSS, 113 eyes with nongradable scores at baseline were excluded.
The results showed that the rate of DMO resolution was 2.5-fold greater in patients randomized to IAI. “The median time to first resolution was 33.0 (95% confidence interval, 28.1-40.0) weeks versus not achieved with laser treatment,” Dr Singh reported.
Regarding the baseline characteristics that may drive the time to resolution, the data, he noted, pointed to a range of such features. The multivariate analysis showed that in the patients treated with IAI, increasing CST and better BCVA were associated with a longer time to DMO resolution. The hemoglobin A1c and DRSS were not significant factors.
When the investigators analyzed the tertiles of the baseline BCVA, they found that “in the IAI-treated group the highest tertile of baseline BCVA (over 66 letters) was associated with a 20% lower rate of DMO resolution versus the lowest tertile (57 letters or less). Similarly, the highest baseline BVCA tertile was associated with longer median time to first DMO resolution versus the lowest tertile (44.1 vs. 28.4 weeks).”
Another finding was that thicker baseline CST was associated with a longer time to DMO resolution. The investigators reported, “In the IAI group, the tertiles of increasing CST were associated with a significantly longer median time to DMO resolution (20.1, 39.1, and 49.1 weeks for tertiles 1, 2, and 3 respectively) and lower cumulative incidence of the event (hazard ratio 0.6 and 0.6 for tertiles 2 and 3 vs tertile 1, respectively). The results for the laser-treated patients were similar.
Dr Singh concluded, “This pooled analysis of data from the VISTA and VIVID studies in patients with DMO, thicker CST and better BCVA in the IAI group were baseline factors associated with longer time to and lower rate of DMO resolution. The baseline hemoglobin A1c or DRSS category did not affect the DMO resolution. These findings may inform physicians and patients regarding expectations of DMO therapy.”