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Table 2 An overview of the studies (n = 11) included in the final analyses

From: Systematic review and mixed treatment comparison of intravitreal aflibercept with other therapies for diabetic macular edema (DME)

Reference

Phase

Design

Randomized patients (n)

Inclusion

Interventions

Baseline ETDRS score, mean (SD)

Follow-up (months)

Primary outcome

Mean change in BCVA (letters) at Month 12

VIVID-DME [13]

III

Randomized, double-blind, multicenter

136

135

135

Patients with DME secondary to diabetes mellitus. BCVA ETDRS letter score between 24 and 73 in the study eye

IVT-AFL 2q4*

IVT-AFL 2q8*

Laser*

60.8 (10.7)

58.8 (11.2)

60.8 (10.6)

12

Mean change in BCVA (ETDRS letters score) at Week 52

+10.5

+10.7

+1.2

VISTA-DME [13]

III

Randomized, double-blind, multicenter

156

154

156

Patients with DME secondary to diabetes mellitus. BCVA ETDRS letter score between 24 and 73 in the study eye

IIVT-AFL 2q4*

IVT-AFL 2q8*

Laser*

58.9 (10.8)

59.4 (10.9)

59.7 (11.0)

12

Mean change in BCVA (ETDRS letters score) at Week 52

+12.5

+10.7

+0.2

IBETA [29] Abstract

III

Randomized, open, single center

23

21

20

Clinically significant DME. Snellen logarithm of minimum angle of 20/40 or worse

Laser fixed → PRN

IVB 1.5 mg + laser

IVTA 4 mg + laser

NR

NR

NR

12

Outcomes included BCVA, OCT-CMT at Week 52

+9.5

+11.5

+12.5

RESTORE [15]

III

Randomized, double-blind, multicenter

111

116

118

Focal or diffuse DME. BCVA letter score between 39 and 78

Laser fixed q4 → PRN*

IVR 0.5 mg q4 → PRN*

IVR 0.5 mg + laser

62.4 (11.1)

64.8 (10.1)

63.4 (10.0)

12

Mean average change in BCVA from baseline to Month 1 through 12

+0.8

+6.1

+5.9

REVEAL [16] Abstract

III

Randomized, double-blind, multicenter

133

132

131

Focal or diffuse DME. BCVA letter score between 39 and 78

IVR 0.5 mg q4 → PRN*

IVR 0.5 mg + laser

Laser fixed q4 → PRN*

NR

NR

NR

12

Mean average change in BCVA from baseline to Month 1 through 12

+6.6

+6.4

+1.8

RELATION [30,31] Abstracts

III

Randomized, double-blind, multicenter

85

43

DME

IVR 0.5 mg + prompt laser

Laser fixed q4 → PRN*

NR

NR

12

Changes in BCVA, OCT-CRT, and FA

+6.5

+1.4

DRCR.net Protocol I [32]

III

Randomized, double-blind, multicenter

293

187

188

186

DME. BCVA letter score between 24 and 78

Laser fixed q4 → PRN*

IVR 0.5 mg + prompt laser

IVR 0.5 mg + deferred laser

IVTA 4 mg + laser

NR

NR

NR

NR

12 (maximum 36)

Mean change in BCVA at month 12

+3

+9

+9

+4

DRCR.net Protocol J [33]

III

Randomized, double-blind, multicenter

123

113

109

DME and presence of severe NPDR or PDR. ETDRS letter score ≥ 24

Laser fixed*

IVR 0.5 mg + laser

IVTA 4 mg + laser

NR

NR

NR

12

Mean change in visual acuity from baseline to Week 14

−6

−4

−5

LUCIDATE [34] Abstract

IV

Randomized, open, single center

11

11

DME. BCVA letter score between 55 and 79

IVR 0.5 mg q4 → PRN

Laser fixed → PRN

NR

NR

11

BCVA ETDRS VA, FA, OCT, microperimetry, full-field and multifocal ERG at Week 48

+6.0

−0.9

Maia et al. (2009) [35]

II/III

Randomized, single-blind, single center

22

22

DR and CSME. ETDRS severity level 65

Laser fixed → PRN

IVTA 4 mg + laser

NR

NR

12

Changes in BCVA, CMT, and TMV

+3**

+16**

PLACID [36]

II

Randomized, double-blind, multicenter

126

127

Diffuse DME. BCVA letter score between ≥ 34 and ≤ 70

Dexamethasone fixed → PRN

Laser fixed → PRN*

57 (9.4)

57.5 (9.5)

12

Proportion who gained ≥ 10 letters from baseline to Month 12

NA

  1. BCVA, best-corrected visual acuity; CMT, central macular thickness; CRT, central retinal thickness; CSME, clinically significant macular edema; DME, diabetic macular edema; DR, diabetic retinopathy; ERG, electroretinography; ETDRS, Early Treatment Diabetic Retinopathy Study; FA, fluorescein angiography; IVB, intravitreal bevacizumab; IVR, intravitreal ranibizumab; IVT-AFL, intravitreal aflibercept; IVTA, intravitreal triamcinolone acetonide; NA, not available; NPDR, non-proliferative diabetic retinopathy; NR, not reported; OCT, optical coherence tomography; PDR, proliferative diabetic retinopathy; PRN, as needed; TMV, total macular volume; VA, visual acuity.
  2. *Includes sham. **Published as logarithm of the minimum angle of resolution used, converted here to ETDRS letters using Gregori NZ, et al. Retina. 2010; 30:1046-50.