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)5 | 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)6 | 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)4 | 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)10 | 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)7 | 24–73 | 56.9 | RBZ 0.5 mg (127) | Monthly | 12 | 12.0 (24 months) | 68.9 (24 months) |
| RISE (377)7 | 24–73 | 56.9 | RBZ 0.5 mg (125) | Monthly | 12 | 11.9 (24 months) | 68.8 (24 months) |
| DA VINCI (221)8 | 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)9 | 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)9 | 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.