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

Table 3

Week 100 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)	2.9 (1.4)	10.4 (1.3)	8.5 (1.4)	7.5 (3.9–11.2)	<0.0001	5.7 (1.9–9.4)	0.0032
LS (SE) mean change in CRT (μm)	−114.7 (14.9)	−182.5 (13.9)	−197.1 (14.8)	−67.8 (−104.6 to −31.0)	0.0003	−82.4 (−120.4 to −44.4)	<0.0001
Gain ≥ 10 letters	19 (24.4)	50 (55.6)	37 (47.4)	32.1 (17.9–46.3)	<0.01	23.3 (8.5–38.1)	<0.01
Gain ≥ 15 letters	7 (9.0)	30 (33.3)	17 (21.8)	25.5 (13.6–37.4)	<0.01	12.9 (1.6–24.2)	0.02
Loss ≥ 10 letters	7 (9.0)	3 (3.3)	4 (5.1)	−5.1 (−12.3 to 2.2)	0.17	−3.7 (−11.7 to 4.2)	0.36
Loss ≥ 15 letters	4 (5.1)	2 (2.2)	2 (2.6)	−2.5 (−8.5 to 3.5)	0.42	−2.5 (−8.6 to 3.5)	0.41
≥2-step DRSS improvement	11 (17.5)	21 (29.6)	23 (35.9)	14.2 (−0.2 to 28.6)	0.05	18.5 (3.2 to 33.7)	0.02

(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)	0.1 (0.8)	11.9 (0.9)	10.8 (0.8)	11.8 (9.5–14.2)	<0.0001	10.7 (8.4–13.0)	<0.0001
LS (SE) mean change in CRT (μm)	−63.8 (8.8)	−215.5 (8.7)	−194.4 (8.5)	−151.7 (−175.1 to −128.3)	<0.0001	−130.5 (−153.7 to −107.4)	<0.0001
Gain ≥ 10 letters	57 (27.4)	127 (63.5)	120 (57.7)	36.0 (26.9–45.0)	<0.01	30.2 (21.2–39.3)	<0.01
Gain ≥ 15 letters	29 (13.9)	81 (40.5)	75 (36.1)	26.6 (18.3–35.0)	<0.01	22.1 (14.0–30.2)	<0.01
Loss ≥ 10 letters	48 (23.1)	7 (3.5)	3 (1.4)	−19.6 (−25.9 to −13.3)	<0.01	−21.6 (−27.6 to −15.7)	<0.01
Loss ≥ 15 letters	28 (13.5)	6 (3.0)	1 (0.5)	−10.4 (−15.6 to −5.2)	<0.01	−13.0 (−17.7 to −8.2)	<0.01
≥2-step DRSS improvement	20 (12.3)	60 (38.7)	61 (37.4)	26.0 (16.7–35.3)	<0.01	25.2 (16.2–34.1)	<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.