Table 1.
Publications providing evidence for the use of ranibizumab in a T&E regimen for wAMD
| Study | Population | Intervention | Outcomes | Topline results | Study duration |
|---|---|---|---|---|---|
| RCT studies | |||||
| Berg et al 201639 (LUCAS) | People with previously untreated AMD (n=441) | Ranibizumab Bevacizumab |
Mean change in VA at 2 years | +6.6 letters at year 2 in ranibizumab group | 24 months |
| Wykoff et al 201511 (TREX) | People with treatment-naïve wAMD (n=20) | Ranibizumab | Mean BCVA change from baseline | +10.5 letters at year 1 | 12 months |
| Silva et al 201832 (TREND) | People with treatment-naïve wAMD (n=323) | Ranibizumab | Change in BCVA from baseline | +6.2 letters at year 1 | 12 months |
| Non-RCT studies | |||||
| Abedi et al 201442 | People with CNV due to AMD (n=120 at 12 months and 101 at 24 months) | Ranibizumab Bevacizumab |
% losing <15 letters and change in BCVA | 97.5% and 95% lost <15 letters at 12 and 24 months, +9.5 and +8 letters at 12 and 24 months | 24 months |
| Toalster et al 201334 | People with CNV due to AMD (n=45) | Ranibizumab | Change in BCVA | +7 letters at month 12 (P=0.008) | 12 months |
| Arnold et al 201541 | People with CNV due to AMD (n=1,011) | Ranibizumab Aflibercept Bevacizumab |
Change in BCVA | +5.3 letters at 24 months | 24 months |
| Calvo et al 201443 | People with CNV due to AMD (n=30 for PRN and n=30 for TREX) | Ranibizumab PRN and TREX |
Change in BCVA of PRN vs TREX | No significant difference in BCVA change between groups (P>0.05) | 36 months |
| Chen et al 201644 | People with CNV due to AMD (n=79) | Ranibizumab | Change in BCVA after induction and extension phases | +8.4 letters during the induction (P<0.001) with maintenance over TREX phase (P=0.81) | |
| Gupta et al 201016 | People with CNV due to AMD (n=92) | Ranibizumab | Change in Snellen VA | Significant improvement at 1 year (P<0.001) and 2 years (P=0.002) follow-up | 24 months |
| Hatz and Prünte 201637 | People with CNV due to AMD (n=70 for PRN and n=70 for TREX) | Ranibizumab PRN and TREX |
Change in BCVA of PRN vs TREX | +0.18 for TREX vs +0.07 for PRN at month 12 (P=0.001) | 12 months |
| Mrejen et al 201545 | People with CNV due to AMD (n=185) | Ranibizumab Aflibercept Bevacizumab |
Change in BCVA | −0.1245 logMAR at 18 months, −0.1061, −0.0896, and −0.0782 logMAR at 3, 4, and 5 years | 72 months |
| Oubraham et al 201136 | People with CNV due to AMD (n=52 for PRN and n=38 for TREX) | Ranibizumab | Change in BCVA of PRN vs TREX | +10.8 letters for TREX vs +2.3 for PRN at month 12 (P=0.036) | 12 months |
| Rayess et al 201535 | People with CNV due to AMD (n=189) | Ranibizumab Bevacizumab |
Change in BCVA | +11.6 letters at year 1, +10.7 at year two and +13.6 at year 3 | 36 months |
| Vardarinos et al 201710 | People with CNV due to AMD (n=54 people at 12 months and n=45 people at 24 months) | Ranibizumab | Change in BCVA at 12 and 24 months | +8.3 letters at month 12 (P<0.001) and +5.2 letters at month 24 (P=0.007) | 24 months |
| Gillies et al 201546,a | People with AMD (n=1,043) | Ranibizumab Bevacizumab Aflibercept |
Change in mean VA | +6.3 letters at month 6, remained above baseline for 5 years and decreased to −2.6 letters at year 7 | 84 months |
Notes:
a
This was not specifically a Treat-and-Extend study; however, the Treat-and-Extend approach seemed to have been favored by investigators.
Abbreviations: CNV, choroidal neovascularization; PRN, pro re nata; VA, visual acuity; BCVA, best corrected visual acuity; TREX, treat and extend; T&E, Treat and Extend; wAMD, wet age-related macular degeneration.