Impact of Baseline Central Retinal Thickness on Outcomes in the VIVID-DME and VISTA-DME Studies

Table 2

Week 52 outcomes of patient subgroups with baseline central retinal thickness < 400 μm or ≥400 μm (integrated data from VIVID-DME and VISTA-DME).

(a)

				2q4 versus laser control		2q8 versus laser control
	Laser control ()	2q4 ()	2q8 ()	Difference (95% CI)^†	value^†	Difference (95% CI) ^†	value^†
Baseline CRT < 400 μm
LS (SE) mean change in BCVA (ETDRS letters)	3.4 (1.1)	10.8 (1.1)	10.5 (1.1)	7.3 (4.3–10.3)	<0.0001	7.1 (3.9-10.2)	<0.0001
LS (SE) mean change in CRT (μm)	−111.9 (13.5)	−181.2 (12.7)	−191.2 (13.5)	−69.3 (−103.0 to −35.7)	<0.0001	−79.3 (−114.0 to −44.6)	<0.0001
Gain ≥ 10 letters	20 (25.6)	46 (51.1)	42 (53.8)	26.2 (11.8–40.6)	<0.01	28.0 (13.1–42.9)	<0.01
Gain ≥ 15 letters	8 (10.3)	27 (30.0)	17 (21.8)	20.2 (8.1–32.2)	<0.01	11.1 (−0.4 to 22.6)	0.06
Loss ≥ 10 letters	6 (7.7)	0 (0)	2 (2.6)	−11.5 (−20.3 to −2.8)	<0.01	−4.9 (−11.5 to 1.8)	0.15
Loss ≥ 15 letters	3 (3.8)	0 (0)	1 (1.3)	−5.8 (−12.2 to 0.6)	0.08	−3.7 (−11.3 to 3.9)	0.34
≥2-step DRSS improvement	9 (15.0)	22 (31.9)	18 (29.5)	17.9 (3.9–32.0)	0.01	14.8 (0.3–29.4)	0.05

(b)

				2q4 versus laser control		2q8 versus laser control
	Laser control ()	2q4 ()	2q8 ()	Difference (95% CI)^†	value^†	Difference (95% CI)^†	value^†
Baseline CRT ≥ 400 μm
LS (SE) mean change in BCVA (ETDRS letters)	−0.2 (0.7)	11.9 (0.7)	10.7 (0.7)	12.1 (10.2–14.1)	<0.0001	10.9 (9.0–12.8)	<0.0001
LS (SE) mean change in CRT (μm)	−43.7	−200.2	−188.0	−156.4 (−177.9 to −135.0)	<0.0001	−144.3 (−165.6 to −123.0)	<0.0001
Gain ≥ 10 letters	44 (21.2)	128 (64.0)	118 (56.7)	42.8 (34.1–51.5)	<0.01	35.6 (26.8–44.3)	<0.01
Gain ≥ 15 letters	16 (7.7)	81 (40.5)	75 (36.1)	32.6 (24.9–40.4)	<0.01	28.4 (20.9–35.9)	<0.01
Loss ≥ 10 letters	41 (19.7)	3 (1.5)	3 (1.4)	−18.2 (−23.9 to −12.5)	<0.01	−18.3 (−23.9 to −12.6)	<0.01
Loss ≥ 15 letters	25 (12.0)	2 (1.0)	0 (0)	−11.0 (−15.6 to −6.3)	<0.01	−12.0 (−16.4 to −7.6)	<0.01
≥2-step DRSS improvement	19 (11.9)	57 (37.0)	49 (30.2)	24.9 (15.8–34.1)	<0.01	18.4 (9.7–27.1)	<0.01

Values are n (%) unless otherwise noted. Adjusted for baseline BCVA. ^†For continuous outcomes, 95% CIs and values were calculated based on an analysis of a covariance model with baseline measurement, dichotomized baseline CRT (<400 μm or ≥400 μm), treatment group, study, and interaction between dichotomized baseline CRT, and treatment as the fixed effect. For binary outcomes, 95% CIs were calculated based on Mantel-Haenszel CI adjusted by study for each baseline CRT subgroup. 2q4: 2 mg every 4 weeks; 2q8: 2 mg every 8 weeks; BCVA: best-corrected visual acuity; CI: confidence interval; CRT: central retinal thickness; DRSS: diabetic retinopathy severity scale; ETDRS: Early Treatment Diabetic Retinopathy Study; LS: least squares; SE: standard error.