Summary of optical coherence tomography, fundus photography and fluorescein angiography findings
| End point | DEX implant 0.7 mg | DEX implant 0.35 mg | Sham procedure |
|---|---|---|---|
| Optical coherence tomography | |||
| Retinal thickness in central subfield, μm | N=348 | N=344 | N=342 |
| BL, mean (SD) | 463.0 (157.1) | 466.8 (159.5) | 460.9 (132.6) |
| Change from BL to month 39, mean (SD) | −117.3 (208.1)***† | −127.8 (196.7)***† | −62.1 (180.1) |
| AUC change from BL during study, mean (SD) | −111.6 (134.1)***† | −107.9 (135.8)***† | −41.9 (116.0) |
| Macular volume, mm3 | N=264 | N=245 | N=250 |
| BL, mean (SD) | 9.73 (2.07) | 9.81 (2.15) | 9.44 (1.85) |
| Change from BL to month 39, mean (SD) | −1.06 (2.22)***‡ | −1.14 (1.75)***‡ | −0.31 (1.62) |
| Fundus photography | |||
| Patients with CSME, %§ | N=313–340 | N=308–336 | N=307–340 |
| Baseline | 96.8 | 98.7*¶ | 95.4 |
| Month 39 | 77.1*¶ | 75.9**¶ | 84.2 |
| Patients with improvement from BL at month 39 | 20.4*¶ | 22.4**¶ | 12.4 |
| Central retinal thickening (disc area) | N=313–340 | N=308–336 | N=307–340 |
| Baseline, mean (SD) | 8.31 (4.15) | 8.51 (4.21) | 7.82 (4.28) |
| Month 39, mean (SD) | 5.34 (4.89)***‡ | 5.38 (4.56)***‡ | 6.13 (4.59) |
| Change from BL to month 39, mean (SD) | −2.75 (4.46)***‡ | −2.93 (4.03)***‡ | −1.49 (3.74) |
| Patients with ≥2-step progression in DRS category from BL (%) | N=324 | N=321 | N=323 |
| Month 39 | 6.2 | 6.2 | 6.2 |
| Cumulative rate of ≥2-step progression in DRS category from BL (%) | N=324 | N=321 | N=323 |
| Month 39 | 10.2*†† | 10.6 | 14.2 |
| Fluorescein angiography | |||
| Macular leakage (disc area) | N=335–346 | N=323–343 | N=340–349 |
| Baseline, mean (SD) | 8.66 (4.73) | 8.64 (4.46) | 7.97 (4.62) |
| Month 39, mean (SD) | 7.68 (4.73) | 7.42 (4.57) | 7.57 (4.69) |
| Change from BL to month 39, mean (SD) | −0.89 (4.10) | −1.06 (3.71) | −0.38 (3.18) |
| Macular capillary loss (disc area) | N=300–334 | N=291–337 | N=311–340 |
| Baseline, mean (SD) | 0.24 (0.66) | 0.19 (0.65) | 0.16 (0.42) |
| Month 39, mean (SD) | 0.34 (0.83) | 0.35 (1.06) | 0.28 (0.93) |
| Change from BL to month 39, mean (SD) | +0.13 (0.52) | +0.17 (0.61) | +0.15 (0.81) |
*p<0.05 vs sham; **p<0.01 vs sham; ***p<0.001 vs sham.
†Based on an analysis of covariance model with treatment and study as fixed effects and baseline value as a covariate.
‡Based on an analysis of covariance model with treatment as a fixed effect and baseline value as a covariate.
§CSME is defined as retinal thickening ≥1 disc area, part ≤1 disc diameter from macula centre or retinal thickening or adjacent hard exudates ≤500 μm from macula centre.
¶Based on Wilcoxon rank-sum test.
††Based on the log-rank test.
AUC, area under curve; BL, baseline; CSME, clinically significant macular oedema; DEX, dexamethasone; DRS, diabetic retinopathy severity.