Table 2.
Key efficacy outcomes in total analysis population and subgroups
| Population | Mean (SD) baseline BCVA, letters | Mean (SD) change from baseline BCVA at 6 months, letters | Mean (SD) change from baseline BCVA at 24 months, letters | Patients with ≥15-letter gain from baseline BCVA at 6 months, % | Patients with ≥15-letter gain from baseline BCVA at 24 months, % |
|---|---|---|---|---|---|
| Total analysis population (N = 375) | 47.6 (21.2) | 5.1 (19.0) | 4.6 (22.3) | 31.3 | 38.7 |
| Subgroups: diagnosis | |||||
| BRVO (N = 202) | 52.8 (17.4) | 5.5 (19.6) | 4.8 (20.5) | 32.4 | 39.9 |
| CRVO (N = 173) | 41.5 (23.5) | 4.6 (18.4) | 4.4 (24.2) | 30.0 | 37.4 |
| Subgroups: duration of ME at baselinea | |||||
| <3 months (N = 180) | 43.3 (22.8) | 8.5 (20.5) | 6.7 (26.3) | 40.3 | 47.9 |
| ≥3 months (N = 183) | 51.4 (19.0) | 2.0 (17.5) | 3.0 (18.5) | 23.0 | 30.1 |
| Subgroups: lens status at baselineb | |||||
| Pseudophakic (N = 101) | 50.2 (19.4) | 4.2 (20.7) | 3.0 (22.2) | 30.2 | 36.2 |
| Phakic without cataract (N = 165) | 48.9 (20.9) | 7.9 (17.0) | 7.1 (21.3) | 36.2 | 45.2 |
| Phakic with cataract (N = 108) | 43.3 (22.8) | 1.4 (20.0) | 2.1 (23.9) | 24.2 | 30.4 |
| Subgroups: treatment status at baseline | |||||
| Naïve (N = 145) | 43.9 (23.1) | 7.5 (20.0) | 5.9 (26.7) | 35.3 | 45.7 |
| Prior DEX treatment (N = 149) | 52.5 (18.9) | 2.0 (16.0) | 2.1 (17.6) | 22.3 | 29.7 |
| Prior treatment, not DEX (N = 79) | 45.3 (20.2) | 8.4 (21.1) | 7.6 (23.1) | 43.8 | 45.2 |
| Subgroups: RVO treatment during study | |||||
| Through 6 monthsc | |||||
| DEX only (N = 254) | 49.3 (19.2) | 6.1 (1.2) | 29.9 | ||
| Single DEX treatment (N = 91) | 47.8 (21.3) | 6.1 (2.3) | 29.7 | ||
| ≥2 DEX treatments (N = 163) | 50.1 (18.0) | 6.0 (1.5) | 29.9 | ||
| ≥1 DEX and other RVO treatments (N = 121) | 44.0 (24.6) | 3.0 (1.8) | 34.3 | ||
| Through entire 24 monthsc | |||||
| DEX only (N = 167) | 47.9 (19.7) | 7.0 (1.6) | 8.3 (2.0) | 30.9 | 45.3 |
| Single DEX treatment (N = 61) | 44.3 (23.0) | 9.3 (3.1) | 20.7 (4.2) | 37.1 | 73.9 |
| ≥2 DEX treatments (N = 106) | 50.0 (17.3) | 6.2 (1.8) | 4.9 (2.2) | 28.7 | 37.3 |
| ≥1 DEX and other RVO treatments (N = 208) | 47.3 (22.4) | 3.7 (1.3) | 2.3 (1.6) | 31.6 | 34.5 |
BCVA Best-corrected visual acuity, BRVO Branch retinal vein occlusion, CRVO Central retinal vein occlusion, DEX implant Dexamethasone intravitreal implant, ME Macular edema, RVO Retinal vein occlusion, SD Standard deviation
aDuration of ME data missing for 12 patients
bLens status data missing for one patient
cMean (SD) change from baseline values are from an ANCOVA model using baseline BCVA as the covariate