Background
Methods
Study participants
Intervention and visit schedule
Outcome assessments and endpoints
Data analysis
Results
Characteristic | DEX 0.7 | Sham |
---|---|---|
n = 247 | n = 261 | |
Patients
| ||
Mean age (SD), yr | 63.0 (8.3) | 63.0 (9.1) |
Male, n (%) | 150 (60.7) | 168 (64.4) |
Caucasian, n (%) | 188 (76.1) | 192 (73.6) |
Mean diabetes duration (SD), yr | 16.4 (8.7) | 16.2 (9.7) |
Type 2 diabetes, n (%) | 220 (89.1) | 238 (91.2) |
Mean HbA1c (SD), % | 7.5 (1.1) | 7.5 (1.0) |
≤8 %, n (%) | 168 (68.0) | 189 (72.4) |
Mean DME duration (SD), mo | 27.3 (26.3) | 31.9 (28.6) |
Study eyes
| ||
Lens status, n (%) | ||
Phakic | 182 (73.7) | 179 (68.6) |
Pseudophakic | 65 (26.3) | 82 (31.4) |
Mean BCVA (SD), ETDRS letters | 55.2 (9.6) | 56.1 (9.1) |
Mean CRT (SD), μm | 478 (153) | 472 (131) |
Prior DME treatment, n (%) | 247 (100) | 261 (100) |
Laser | 231 (93.5) | 243 (93.1) |
Intravitreal triamcinolone acetonide | 58 (23.5) | 61 (23.4) |
Intravitreal anti-VEGF | 25 (10.1) | 26 (10.0) |
At least 2 of the 3 types of treatment | 61 (24.7) | 57 (21.8) |
No prior DME treatment, n (%) | 0 (0) | 0 (0) |
Endpoint | DEX 0.7 | Sham | Mean Difference | P Value |
---|---|---|---|---|
n = 247 | n = 261 | |||
Patients with BCVA ≥15-letter improvement from baseline at study end, % | 21.5 | 11.1 | 10.3 | 0.002b |
Mean BCVA average change from baseline during the study (SD), lettersa | +3.2 (8.7) | +1.5 (7.5) | 1.6 | 0.024c |
Mean CRT average change from baseline during the study (SD), μma | −126 (131) | −39 (121) | −85 | <0.001c |
Prior Steroid | Prior Anti-VEGF | Prior Laser | ||||
---|---|---|---|---|---|---|
Endpoint | DEX 0.7 | Sham | DEX 0.7 | Sham | DEX 0.7 | Sham |
n = 58 | n = 61 | n = 25 | n = 26 | n = 231 | n = 243 | |
Patients with BCVA ≥15-letter improvement from baseline at study end, % | 27.6 | 8.2 | 28.0 | 7.7 | 21.2 | 11.9 |
Mean BCVA average change from baseline during the study (SD), lettersa | +4.9 (7.4) | −0.6 (8.6) | +4.2 (8.8) | +1.6 (7.6) | +3.1 (8.7) | +1.6 (7.5) |
Mean CRT average change from baseline during the study (SD), μma | −121 (150) | −30 (135) | −130 (95) | −42 (123) | −123 (130) | −39 (121) |
Endpoint | DEX 0.7 | Sham | Mean Difference |
---|---|---|---|
n = 61 | n = 57 | (95 % CI) | |
Patients with BCVA ≥15-letter improvement from baseline at study end, % | 26.2 | 8.8 | 17.5 (4.2, 30.7)c |
Mean BCVA average change during the study, lettersb | 4.0 | −0.3 | 3.8 (1.1, 6.5)d |
Mean CRT average change during the study, μmb | −108 | −26 | −111 (−154, −69)d |
Previously Treated Patients | Total Study Population | |||
---|---|---|---|---|
Incidence, % | DEX 0.7 | Sham | DEX 0.7 | Sham |
n = 247 | n = 261 | n = 347 | n = 350 | |
Serious ocular AE | 6.9 | 0.8 | 6.9 | 1.1 |
IOP-related AEa | 38.1 | 4.6 | 36.0 | 5.1 |
Cataract-related AE (incidence in phakic eyes) | 70.3 | 20.1 | 67.9 | 20.4 |