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Sundeep Kasi, Allen Ho; Impact of Presence or Absence of Posterior Vitreous Detachment (PVD) at Baseline on Treatment Outcomes for Diabetic Macular Edema (DME) in the VISTA and VIVID trials. Invest. Ophthalmol. Vis. Sci. 2017;58(8):930.
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© ARVO (1962-2015); The Authors (2016-present)
To examine impact of presence or absence of posterior vitreous detachment (PVD) at baseline on visual and anatomic outcomes in patients with diabetic macular edema (DME).
VISTA and VIVID were two similarly designed phase 3 trials that treated 461 and 404 DME patients, respectively, with intravitreal aflibercept (IAI) 2 mg q4 weeks (2q4), IAI 2 mg q8 weeks following 5 monthly doses (2q8), or laser control with monthly follow-up through week 100. Starting at week 24, if rescue treatment criteria were met, IAI patients received active laser, and laser control patients received IAI 2q8 following 5 monthly doses. Presence or absence of PVD was captured via indirect ophthalmoscopy by the investigator. Outcomes at week 100 were evaluated based on presence or absence of baseline PVD: mean change from baseline in best-corrected visual acuity (BCVA), mean change in central retinal thickness (CRT) measured by SD-OCT, and proportion of patients achieving > 2-step Diabetic Retinopathy Severity Scale (DRSS) score improvement. Data from patients who received rescue treatment were censored at time of rescue from analysis.
At baseline, PVD was present in 15%, 17%, and 13% of the 2q4, 2q8, and laser control groups, respectively. Baseline BCVA and CRT values were balanced among treatment groups and between patients with and without baseline PVD. At week 100, within corresponding treatment groups, mean changes in BCVA and CRT from baseline in patients with baseline PVD did not differ significantly from those without baseline PVD (Table). Additionally, at week 100, the proportion of patients with > 2-step DRSS improvement in 2q4, 2q8, and laser control groups was 42.1%, 33.3%, and 13.3%, respectively, in patients with baseline PVD. In patients without baseline PVD, corresponding proportions were 34.6%, 37.8%, and 13.8%, respectively. The most frequent ocular serious adverse event from baseline to week 100 was cataract (2.4%, 1.0%, and 0.3% for the 2q4, 2q8, and laser groups, respectively).
In the VIVID and VISTA trials, few patients had PVD present at baseline as determined by the investigator. Presence or absence of PVD at baseline did not appear to influence visual, anatomic, and DRSS outcomes in patients with DME treated with IAI or laser through week 100.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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