State of the art management of diabetic macular edema

Table 2 Summary of the studies using intravitreal Ranibizumab for treatment of diabetic macular edema

Name ofstudy	Purpose	Study design	Outcomes measures	IVR dose	Interval of injection	Naive or refractory /DME	Duration of study	Number of eyes	Treatment regimen	Results
READ-2 study[73]	IVR for DME	3-arm RCT	BCVA and CMT	0.5 mg	1 and 2 mo	Naïve or refractory	2 yr	126	Group 1 (IVR, n = 42 eyes) injections of 0.5 mg ranibizumab at baseline, 1, 3 and 5 mo Group 2 (L, n = 42 eyes) focal/grid laser at baseline and 3 mo if CMT ≥ 250 μm Group 3 (IVRL, n = 42 eyes) IV injections of 0.5 mg ranibizumab at baseline and 3 mo, followed by focal/grid laser treatment 1 wk later	BCVA changes (letters) P value IVR +7.24 0.0003 vs L L -0.43 IVRL +3.80 CMT changes (μm) IVR -106.3 All < 0.01 vs baseline L -82.8 IVRL -117.2
RESTORE study[74]	IVR for DME	3-arm RCT	BCVA and CMT	0.5 mg	1 mo	Naïve or refractory	1 yr	345	Group 1 (IVR, n = 116 eyes) IV ranibizumab plus sham laser Group 2 (IVRL, n = 118 eyes) 0.5 mg IV ranibizumab plus active laser Group 3 (L, n = 111 eyes) laser treatment plus sham injections	BCVA changes (letters) P value IVR +6.1 SD6.43 < 0.0001 IVRL +5.9 SD7.92 < 0.0001 L +0.8 SD8.56 CMT changes (μm) P value IVR -118.7 < 0.0002 IVRL -128.3 < 0.0001 L -61.3
REVEAL study[75]	IVR for DME	3-arm RCT	BCVA and CMT	0.5 mg	1 mo	NR	1 yr	396	Group 1 (IVR 0.5 mg + sham laser, n = 133) day 1, month 1, 2 and pro-renata thereafter based on BCVA Group 2 (IVR 0.5 mg + active laser, n = 132) day 1, month 1, 2 and pro-renata thereafter based on BCVA Group 3 (sham injection + active laser, n = 131)	BCVA (letters) and CRT(μm) changes: P value IVR + sham laser +6.6; -148.0 < 0.0001 IVR +laser +6.4; −163.8 < 0.0001 Laser + sham +1.8; -57.1
RESOLVE study[76]	IVR for DME	3-arm RCT	BCVA and CMT	0.3 and 0.5 mg	1 mo	Naïve and refractory	1 yr	151	Group 1 (IVR 0.3, n = 51 eyes) 0.3 mg (0.05 mL) IV ranibizumab, 3 monthly injections Group 2 (IVR 0.5, n = 51 eyes) 0.5 mg IV (0.05 mL) ranibizumab, 3 monthly injections Group 3 (C, n = 49 eyes) sham	BCVA changes P value IVR 0.3 +11.8 SD6.6 < 0.0001 vs C IVR0.5 +8.8 SD11.0 < 0.0001 vs C C -1.4 SD14.2 CMT (μm) P value IVR0.3 -200.7 SD122.2 < 0.0001 vs C IVR0.5 -187.6 SD147.8 < 0.0001 vs C C -48.4 SD153.4
RISE study[77]	IVR for DME	3-arm RCT	BCVA and CMT	0.3 and 0.5 mg	1 mo	Naïve or refractory	2 yr	377	Group 1 (IVR 0.3 mg, n = 125 eyes) Group 2 (IVR 0.5 mg, n = 125 eyes) Group 3 (C, n = 127 eyes): sham injection	BCVA changes (letters): P value IVR0.3 +12.5 < 0.0001 IVR0.5 +11.9 < 0.0001 C +2.6 CFT (μm): IVR0.3 -250.6 < 0.0001 IVR0.5 -253.1 < 0.0001 C -133.4
RIDE study[77]	IVR for DME	3-arm RCT	BCVA and CMT	0.3 and 0.5 mg	1 mo	Naïve or refractory	2 yr	382	Group 1 (IVR 0.3 mg, n = 125 eyes) Group 2 (IVR 0.5 mg, n = 127 eyes) Group 3 (C, n = 130 eyes): sham injection	BCVA (letters) and CMT (μm): P value IVR0.3 +10.9, -259.8 < 0.0001 IVR0.5 +12.0, -270.7 < 0.0001 C +2.3, -125.8

DME: Diabetic macular edema; BCVA: Best corrected visual acuity; CMT: Central macular thickness. IVR: Intravitreal ranibizumab.