Table 4.
Alternative Treatments Received for Diabetic Macular Edema
Sham + Prompt Laser N = 293 | Ranibizumab + Prompt Laser N = 187 | Ranibizumab + Deferred Laser N = 188 | Triamcinolone + Prompt Laser N = 186 | |
---|---|---|---|---|
Prior to the 1 year visit | ||||
Eyes with alternative treatments (number of treatments applied) | 14 (25) | 1 (1) | 0 | 1 (1) |
Per protocol, no.* | 5 | 1 | 0 | 1 |
Deviations from protocol, no. | 9 | 0 | 0 | 0 |
Alternative treatments, no.† | ||||
Intravitreal Bevacizumab | 3 | 0 | 0 | 1 |
Intravitreal Triamcinolone Acetonide | 5 | 1 | 0 | 0 |
Vitrectomy | 2 | 0 | 0 | 0 |
Intravitreal Bevacizumab + Intravitreal Triamcinolone Acetonide | 4 | 0 | 0 | 0 |
1 year through prior to the 2 year visit | ||||
Eyes with alternative treatments (number of treatments) | 29 (55) | 1 (1) | 0 | 3 (4) |
Per protocol, no.* | 20 | 1 | 0 | 2 |
Deviations from protocol, no. | 9 | 0 | 0 | 1 |
Alternative Treatments, no.† | ||||
Intravitreal Bevacizumab | 9 | 0 | 0 | 0 |
Intravitreal Ranibizumab | 2 | 0 | 0 | 0 |
Intravitreal Triamcinolone Acetonide | 12 | 1 | 0 | 2‡ |
Vitrectomy | 2 | 0 | 0 | 0 |
Vitrectomy + Intravitreal Triamcinolone Acetonide | 0 | 0 | 0 | 1 |
Intravitreal Bevacizumab + Intravitreal Ranibizumab | 1 | 0 | 0 | 0 |
Intravitreal Bevacizumab + Intravitreal Triamcinolone Acetonide | 2 | 0 | 0 | 0 |
Intravitreal Bevacizumab + Intravitreal Ranibizumab + Intravitreal Triamcinolone Acetonide | 1 | 0 | 0 | 0 |
Per protocol if met failure. Failure is defined as: Visual acuity 10 or more letters worse than baseline, optical coherence tomography central subfield thickness ≥250 microns, diabetic macular edema present on clinical exam that is the cause of the visual loss, complete laser given AND ≥13 weeks since last laser treatment with no improvement since the last laser treatment
Number of eyes, each combination of treatment only counted once
Non-study drug was given (intravitreal Kenalog)