Abstract
Purpose :
To assess impact of delayed treatment in diabetic macular edema (DME) in the VISTA/VIVID trials and initiating treatment in moderately severe to severe non-proliferative diabetic retinopathy (NPDR) in the PANORAMA trial.
Methods :
In this post hoc analysis in VIVID/VISTA, efficacy outcomes were compared between eyes that received intravitreal aflibercept injection (IAI) 2 mg every 4 weeks (2q4; n=290) or every 8 weeks (2q8 after 5 initial monthly doses; n=286) through 100 weeks, or laser with rescue (with 2q8 regimen) due to vision loss (from week 24 for up to ~76 weeks; n=109). Rescue initiation (RI) in VISTA/VIVID was synchronized to the baseline for initially treated patients, with outcomes assessed at week 100 from baseline. In PANORAMA, eyes with moderately severe to severe NPDR without DME received IAI every 16 weeks (2q16 after loading phase; n=135) or every 8 weeks (2q8/PRN after loading phase; n=134) or sham (n=133). All patients could receive rescue at investigator’s discretion for events of PDR/anterior segment neovascularization (ASNV; 1 IAI injection and/or panretinal photocoagulation) or center-involved DME (CI-DME; IAI PRN).
Results :
In VISTA/VIVID, mean best-corrected visual acuity (letters) with 2q4 and 2q8, respectively, was 59.8 and 59.1 (baseline) and 71.5 and 70.2 (week 100), and was 59.5 (baseline), 49.0 (RI), and 57.9 (week 100) for laser/rescue. Mean central subfield thickness (CST) (µm) with 2q4 and 2q8, respectively, was 493.1 and 497.6 (baseline) and 289.4 and 290.1 (week 100), and 537.5 (baseline), 538.5 (RI), and 272.9 (week 100) for laser/rescue. In PANORAMA, in the 2q16, 2q8, and sham groups, respectively, 3.0%, 3.7%, and 14.3% of patients were rescued for PDR/ASNV, and 7.4%, 8.2%, and 29.3% were rescued for CI-DME, through 100 weeks. Benefit was seen in the patients treated with IAI versus sham/rescue with respect to progression of diabetic retinal disease.
Conclusions :
Patients with DME in VIVID/VISTA who received delayed IAI treatment did not achieve similar final visual acuity as those who initiated IAI at study start, despite achieving similar CST. These analyses from VIVID/VISTA and PANORAMA suggest earlier treatment could be clinically beneficial in both DME and NPDR patients.
This is a 2021 ARVO Annual Meeting abstract.