Baseline visual acuity strongly predicts visual acuity gain in patients with diabetic macular edema following anti-vascular endothelial growth factor treatment across trials

Figures & data

Table 1 Characteristics of nine clinical trials with RBZ and AFL in DME

Study (n)	BCVA inclusion range (ETDRS letters)	Mean BCVA at baseline (ETDRS letters)	Agent and dose (n)	Treatment algorithm	Meana number of injections/year	BCVA gain at 12 monthsa (ETDRS letters)	Absolute BCVA at 12 monthsa (ETDRS letters)
DRCR.net Protocol I (691)^Citation5	24–78	63.0	RBZ 0.5 mg + prompt laser (187)	Four loading monthly injections and then PRN until ≥84 letters/<250 µm	9.0 (median)	9.0	72.0
			RBZ 0.5 mg + deferred laser (188)
RESOLVE (151)^Citation6	39–73	60.2	RBZ 0.3/0.6 mg and RBZ 0.5/1.0 mg (mean dose 0.6 mg; 102)	Three fixed monthly injections and then PRN until ≥79 letters/≤225 µm	10.0	10.3	70.5
RESTORE (345)^Citation4	39–78	64.8	RBZ 0.5 mg (116)	Fixed dosing until stable for three consecutive visits and then PRN	7.0	6.8	71.6
		63.4	RBZ 0.5 mg + laser (118)		6.8	6.4	69.8
RETAIN (372)^Citation10	39–78	61.7	RBZ 0.5 mg T&E + laser (121)	Three initial monthly doses and then T&E Three initial monthly doses and then PRN	7.6	6.8	68.5
		63.9	RBZ 0.5 mg T&E monotherapy (128)		7.7	6.8	70.7
		64.7	RBZ 0.5 mg PRN (123)		7.0	7.4	72.1
RIDE (382)^Citation7	24–73	56.9	RBZ 0.5 mg (127)	Monthly	12	12.0 (24 months)	68.9 (24 months)
RISE (377)^Citation7	24–73	56.9	RBZ 0.5 mg (125)	Monthly	12	11.9 (24 months)	68.8 (24 months)
DA VINCI (221)^Citation8	24–73	59.9	AFL 2q4 (44)	Three initial monthly doses and then 2 mg every 4 weeks (2q4) or 8 weeks (2q8)	10.8	13.1	73.0
		58.8	AFL 2q8 (42)		7.2	9.7	68.5
		59.6	AFL 2PRN (45)	Three initial monthly doses and then 2 mg PRN	7.4	12.0	71.6
VIVID (404)^Citation9	24–73	60.8	AFL 2q4 (136)	Five initial monthly doses and then 2 mg every 4 weeks (2q4) or 8 weeks (2q8)	12.2	10.5	71.3
		58.8	AFL 2q8 (135)		8.7	10.7	69.5
VISTA (461)^Citation9	24–73	58.9	AFL 2q4 (154)	Five initial monthly doses and then 2 mg every 4 weeks (2q4) or 8 weeks (2q8)	11.8	12.5	71.4
		59.4	AFL 2q8 (151)		8.4	10.7	70.1

Note:

a Unless otherwise specified.

Abbreviations: RBZ, ranibizumab; AFL, aflibercept; DME, diabetic macular edema; DRCR.net, Diabetic Retinopathy Clinical Research Network; BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; PRN, pro re nata; T&E, treat and extend; 2q4, 2 mg intravitreal aflibercept every 4 weeks; 2q8, 2 mg intravitreal aflibercept every 8 weeks; 2PRN, 2 mg intravitreal aflibercept pro re nata.

Figure 1 The mean BCVA gain across nine clinical trials of anti-VEGF agents in DME.

Note: ^a24-month data.
Abbreviations: BCVA, best-corrected visual acuity; VEGF, vascular endothelial growth factor; DME, diabetic macular edema; ETDRS, Early Treatment Diabetic Retinopathy Study; T&E, treat and extend; PRN, pro re nata; def laser, deferred laser; 2q8, 2 mg intravitreal aflibercept every 8 weeks; 2q4, 2 mg intravitreal aflibercept every 4 weeks; 2PRN, 2 mg intravitreal aflibercept pro re nata.

Figure 2 Regression analysis of mean BCVA gains versus mean baseline BCVA in the nine trials.

Abbreviations: BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study.

Figure 3 Baseline, gained, and final BCVA by trial and regimen.

Notes: ^aMedian. ^b24-month data.
Abbreviations: BCVA, best-corrected visual acuity; VA, visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; 2q8, 2 mg intravitreal aflibercept every 8 weeks; 2q4, 2 mg intravitreal aflibercept every 4 weeks; 2PRN, 2 mg intravitreal aflibercept pro re nata; PRN, pro re nata; def laser, deferred laser; T&E, treat and extend.

Figure 4 Mean change in BCVA from baseline to month 12 by baseline BCVA.

Note: Data from RESTORE.⁴
Abbreviations: BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study.

Figure 5 Mean change in BCVA from baseline to months 12 and 24 by baseline BCVA.

Note: Data from RETAIN (on file).
Abbreviations: BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; T&E, treat and extend; PRN, pro re nata.

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