Abstract
Purpose:
To determine whether drug and regimen effect on visual acuity (VA) depends on baseline retinal pigment epithelial elevation (RPEE) in VIEW 1 and 2 studies.
Methods:
2457 patients with treatment-naïve neovascular age-related macular degeneration (NVAMD) were randomized to four treatment groups: ranibizumab 0.5mg every 4 weeks (Rq4), intravitreal aflibercept (IAI) 2mg every 4 weeks (2q4), 0.5mg every 4 weeks (0.5q4), and 2mg every 8 weeks (2q8). The 0.5q4 group was not included in these analyses. RPEE definition included serous pigment epithelial detachment (PED) and those due to choroidal neovascular membrane complex or blood components.
Results:
There were 1349 patients with known RPEE at baseline: 435, 460, and 455 in Rq4, 2q4 and 2q8, respectively. At baseline, corresponding VA among eyes with RPEE was 54.6, 54.7 and 54.0, and among those without, it was 52.4, 52.4 and 53 ETDRS letters. Effect on VA change over week 52 was dependent on RPEE status at baseline and treatment group. In eyes given 2q4, by week 52, VA improvement and cumulative incidence of eyes gaining > 15 letters, was not significantly different, regardless of baseline RPEE (Relative risk (RR) = 0.96 (95% CI: 0.70, 1.33). In contrast, for both Rq4 and 2q8 groups, at week 52, mean improvement in VA in eyes without baseline RPEE was greater than for those with baseline RPEE, and this difference was statistically similar for Rq4 (4 letters) and 2q8 (2 letters) groups. Cumulative incidence of eyes gaining > 15 letters was also greater for eyes without baseline RPEE compared to those with baseline RPEE [Rq4: RR = 0.70 (95% CI: 0.52: 0.95); 2q8: RR= 0.66 (95% CI: 0.50, 0.90)].
Conclusions:
Visual acuity at week 52 depended on presence of baseline RPEE and treatment regimen. IAI 2q4 effectively improved VA in eyes with or without baseline RPEE, while IAI 2q8 and Rq4 had more favorable effect on VA in eyes without baseline RPEE. These data may help inform clinician’s initial treatment regimen choice in eyes with NVAMD.
Keywords: 412 age-related macular degeneration