Table 5.
Overview of the functional and anatomic results of dexamethasone intravitreal (DEX) and fluocinolone intravitreal implants.
| Study | Ref. | Duration (m) | Regimen | N (eyes) | BCVA (ETDRS letters) | CRT (µm) | ||
|---|---|---|---|---|---|---|---|---|
| Baseline | Change | Baseline | Change | |||||
| MEAD | [100] | 36 | DEX 0.35 mg | 351 | 56.1 (9.9) | 18.4%1∗∗∗ | 463.0 (157.1) | −107.9 (135.8)∗∗∗ |
| DEX 0.7 mg | 347 | 55.5 (9.7) | 22.2%1∗∗ | 466.8 (159.5) | −111.6 (134.1)∗∗∗ | |||
| Sham | 350 | 56.9 (8.7) | 12.0%1 | 460.9 (132.6) | −41.9 (116.0) | |||
|
| ||||||||
| BEBORDEX | [104] | 12 | DEX 0.7 mg | 46 | 55.5 (12.5) | 7.9 (11.6) | 474.3 ± 95.9 | −179.0 (88.8)∗∗ |
| Beva 0.5 mg | 42 | 56.3 (11.9) | 7.5 (11.0) | 503 ± 140.9 | −93.0 (131.6) | |||
| [105]† | 24 | DEX 0.7 mg | 46 | 55.5 (12.5) | 6.9 (2.7 to 11.1) | 474.3 ± 95.9 | N.A. | |
| Beva 0.5 mg | 42 | 56.3 (11.9) | 9.6 (6.9 to 12.3) | 503 ± 140.9 | N.A. | |||
|
| ||||||||
| Shah et al | [107] | 7 | DEX 0.7 mg | 27 | 59 (12) | 5.8 (7.6) | 458 (100) | −122 (95)∗∗∗ |
| Beva 0.5 mg | 23 | 59 (13) | 5.6 (6.1) | 485 (122) | −14 (141) | |||
|
| ||||||||
| Maturi et al | [108] | 6 | DEX + Rani | 65 | 63 (12) | 2.7 (9.8) | 375 (97) | −110 (86)∗∗∗ |
| Sham + Rani | 64 | 63 (13) | 3.0 (7.1) | 396 8122) | −62 (97) | |||
|
| ||||||||
| FAME | [132] | 24 | IFSR 0.2 µg | 375 | 53.3 (12.7) | p = 0.019 | 460.8 (160.0) | p ≤ 0.003 |
| IFSR 0.5 µg | 393 | 52.9 (12.2) | p = 0.015 | 485.1 (173.8) | p ≤ 0.003 | |||
| Sham | 185 | 54.7 (11.3) | — | 451.3 (152.0) | — | |||
|
| ||||||||
| FAME‡ | [133] | 36 | IFSR 0.2 µg | 165 | 54.7 (11.7) | 2.4 | 466.6 (152.9) | −173.1∗ |
| Sham | 72 | 557. (11.5) | 2.3 | 435.0 (149.1) | −115.6 | |||
|
| ||||||||
| FAME‡‡ | [133] | 36 | IFSR 0.2 µg | 209 | 52.2 (13.4) | 7.6∗∗ | 456.2 (165.9) | −186.8 |
| Sham | 112 | 54.0 (11.5) | 1.8 | 461.8 (153.5) | −160.0 | |||
Note. ∗ p < 0.05 vs. comparator/sham. ∗∗p < 0.01 vs. comparator/sham. ∗∗∗p < 0.001 vs. comparator/sham. ∗∗∗∗p < 0.0001 vs. comparator/sham. 1Proportion of patients with a ≥ 15-letter improvement in best-corrected visual acuity (BCVA) from baseline at the year 3. †For those eyes that were pseudophakic at baseline, the mean improvement in BCVA was 8.9 letters (95% confidence interval (CI), 2.0–13.4) for those treated with the dexamethasone (DEX) implant and 7.7 letters (95% CI, 3.03–14.8) for those treated with bevacizumab; p = 0.77. For the eyes that were phakic at baseline, the mean improvement in BCVA was 5.8 letters (95% CI, 0.07–11.5) for those treated with the DEX implant and 10.2 letters (95% CI, 7.17–13.3) for those treated with bevacizumab; p = 0.19. The specific data regarding central retinal thickness of BEVORDEX study at 24 months are not available from the literature [105] and hence are not listed in this table. Shah et al. [107] measured central subfoveal thickness. Maturi et al. [108] measured central subfoveal thickness. FAME: The specific data regarding BCVA and central retinal thickness are not available from the literature [112] and hence are not listed in this table. The p value corresponded to the difference between intravitreal fluocinolone sustained-release (IFSR) and sham. ‡Nonchronic diabetic macular edema (DME) (<3 years). ‡‡Chronic DME (≥3 years). m: months; BCVA: best-corrected visual acuity; EDTRS: Early Treatment of Diabetic Retinopathy Study; CRT: central retina thickness; DEX: dexamethasone implant; Beva: bevacizumab; IFSR: intravitreal fluocinolone sustained-release.