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. 2020 Jun 28;10(6):e032128. doi: 10.1136/bmjopen-2019-032128

Table 3.

Summary of the efficacy and safety in real-world studies

Study
(year, country)
Endpoint time (months) Arms Change in mean BCVA at month 6 Change in CRT (μm) at month 6 Comparison of the changes in BCVA and CRT Change in BCVA at month 12 or at the end of follow-up Change in CRT (μm) at month 12 Comparison of the changes in BCVA and CRT Safety
Kumar et al
(2019, India)38
6 RNB +18 letters† −213.81† More gain, equal reduction NR NR NR IOP increase
6 DEX +9.5 letters† −207.27† Less gain, equal reduction NR NR NR More IOP increase
Ozkaya et al
(2018)26
6, 12, 24 RNB −0.11 logMAR† −133† Gain, reduction −0.15 logMAR†# (month 24) −193†
(month 24)
Gain, reduction Cataract progression: 5.7%*, no IOP increase >10 mmHg
6, 12, 24 DEX −0.08 logMAR −171† No change, reduction −0.06 logMAR (month 24) −256†
(month 24)
No change, reduction Cataract progression: 46.1%, IOP increase >10 mmHg: 22%
Yucel et al
(2018, Turkey)27
6 RNB −0.20 logMAR† −162.7† Numerical gain, equal reduction NR NR NR, NR Cataract (%): 1 (5.6%), IOP increase >25 mmHg: 2 (11.1%)
6 Afl −0.27 logMAR† −310.1† Numerical gain, equal reduction NR NR NR, NR Cataract (%): 1 (6.3%), IOP increase >25 mmHg: 1 (6.3%)
6 DEX −0.11 logMAR −193.8† Numerical gain, equal reduction NR NR NR, NR Cataract (%): 7 (29.2%), IOP increase >25 mmHg: 5 (20.8%)
Winterhalter et al
(2018, Germany)28
6 RNB BRVO: +8 letters, −0.16 logMAR†
CRVO: +5 letters, −0.10 logMAR
BRVO: −194†
CRVO: −204†
BRVO: equal gain, equal reduction
CRVO: no change
Comparable BCVA gains and CRT reduction in BRVO  NR NR, NR No systemic AE
6 DEX BRVO: +10 letters, −0.19 logMAR†
CRVO:
−4 letters, 0.08 logMAR
BRVO: −149†
CRVO: −208†
BRVO: equal gain, equal reduction
CRVO: slight loss, equal reduction
Undertreatment in CRVO NR NR, NR IOP increase >3 mmHg: 6/15 (53.3%)
Yuksel et al (2018, Turkey)29 6–11.9 RNB +7.1 letters, −0.12 logMAR −206.5 (40.9%) Less gain, more reduction (numerically) −0.11 logMAR† −241.3 (47.8%) Less gain, more reduction (numerically) IOP mean increase: −0.6 mmHg
6–13.9 DEX +13.5 letters, −0.27 logMAR −166.4 (32.5%) More gain, less reduction (numerically) +13.5 letters, −0.27 logMAR† −146.5 (28.6%) More gain, less reduction (numerically) IOP mean increase: 3 mmHg*
Kaldirim et al (2017, Turkey)30 6 RNB −0.35 logMAR† −195.36† More gain, more reduction NR NR NR IOP mean decrease: 0.31 mmHg
6 Afl −0.38 logMAR† −241.06† More gain, more reduction NR NR NR IOP mean decrease: 0.15 mmHg
6 DEX −0.26 logMAR† −163.15† Less gain*, less reduction*
(ANOVA test)
NR NR NR IOP mean increase: 1.8 mmHg*
Chatziralli et al
(2017, Greece)31
6–12 RNB +8.9 letters −303.3 More gain, more reduction (numerically) +8.4 letters† −260 µm† Equal gain, equal reduction Cataract: 1/25 (4%), IOP increase: none
6–12 DEX +4.1 letters −228.0 Less gain, less reduction (numerically) +6.9 letters† −197 µm† Equal gain, equal reduction Cataract: 3/17 (17.6%), IOP increase: 2/17 (11.8%)
Gu et al
(2017, China)32
6 RNB CRVO: +10.5 letters†
BRVO: +6.3 letters†
CRVO:−283.2†
BRVO: −84.6†
Equal gain and reduction
Equal gain and reduction
NR NR NR Stable lens opacities and IOP
6 DEX CRVO: +6.9 letters†
BRVO: +5.8 letters†
CRVO:−444.6†
BRVO:−139.8†
Equal gain and reduction
Equal gain and reduction
NR NR NR Stable lens opacities, IOP elevation but quite stable
Mayer et al
(2015, German)33
6, 12 RNB CRVO: +8.9 letters, −0.2 logMAR
BRVO: +8.6 letters, −0.2 logMAR
CRVO: −90.3†
BRVO: −82.9†
NR, NR CRVO: +6.9 letters
BRVO: +12.5 letters
CRVO:
−200.1†
BRVO:
−215.8†
CRVO: equal gain, NR
BRVO: equal gain, NR
No systemic AE
6, 12 DEX CRVO: +7.6 letters, −0.15 logMAR
BRVO: +17.9 letters, −0.35 logMAR
CRVO:−181.9†
BRVO:−191.4†
NR, NR CRVO: +8.4 letters
BRVO: +10.7 letters
CRVO:
−303.9†
BRVO:
−194.1†
CRVO: equal gain, NR
BRVO: equal gain, NR
Cataract progression: 50%, IOP increase >5 mmHg: 50%
Kim et al
(2015, Korea)34
6–12 Bev −0.21 logMAR* −157.15* Gain, more reduction −0.23 logMAR Bev:
−160.09
Equal gain and reduction No lens opacity increase ≥2 grades, no IOP increase
6–12 DEX +0.19 logMAR −48.98 Loss, less reduction −0.19 logMAR DEX:
−140.70
Equal gain and reduction one eye lens opacity increase ≥2 grades, no IOP increase
Chiquet et al
(2015, France)35
6–12 anti-VEGF −0.1 logMAR† −138 (−20%)† Equal gain, equal reduction −0.1 logMAR −210
(−32%)†
Equal gain and reduction Cataract surgery: 10.9%, IOP>21 mmHg: 3.1%*
6–12 DEX −0.3 logMAR† −153 (−17%)† Equal gain, equal reduction −0.3 logMAR† −137
(−20%)†
Equal gain and reduction Cataract surgery: 7.9%, IOP>21 mmHg: 21%
Nghiem-Buffet et al
(2014, France)36
BRVO: 15.8
CRVO: 18.4
RNB NR NR BRVO: +9.2 letters†
CRVO: +18.2 letters†
NR, NR No cataract progression, no IOP rise >10 mmHg
BRVO: 13.2
CRVO: 11.4
DEX NR NR BRVO: +5.8 letters†
CRVO: +16.8 letters†
NR, NR Cataract progression: 1 (2.4%), IOP rise >10 mmHg: 7 (17%)

*Statistically significant difference between anti-VEGF and DEX.

†Statistically significant difference from baseline.

Afl, aflibercept; ANOVA, analysis of variance; BCVA, best-corrected visual acuity; Bev, bevacizumab; BRVO, branch retinal vein occlusion; CRT, central retinal thickness; CRVO, central retinal vein occlusion; DEX, dexamethasone implant; IOP, intraocular pressure; NR, not reported; RNB, ranibizumab; VEGF, vascular endothelial growth factor.