Byooviz (Page 5 of 6)
14.2 Macular Edema Following Retinal Vein Occlusion (RVO)
The safety and efficacy of ranibizumab were assessed in two randomized, double-masked, 1-year studies in patients with macular edema following RVO. Sham controlled data are available through Month 6. Patient age ranged from 20 to 91 years, with a mean age of 67 years. A total of 789 patients (ranibizumab 0.3 mg, 266 patients; ranibizumab 0.5 mg, 261 patients; sham, 262 patients) were enrolled, with 739 (94%) patients completing through Month 6. All patients completing Month 6 were eligible to receive ranibizumab injections guided by pre-specified re-treatment criteria until the end of the studies at Month 12.
In Study RVO-1, patients with macular edema following branch or hemi-RVO, received monthly ranibizumab 0.3 mg or 0.5 mg intravitreal injections or monthly sham injections for 6 months. All patients were eligible for macular focal/grid laser treatment beginning at Month 3 of the 6-month treatment period. Macular focal/grid laser treatment was given to 26 of 131 (20%) patients treated with 0.5 mg ranibizumab and 71 of 132 (54%) patients treated with sham.
In Study RVO-2, patients with macular edema following central RVO received monthly ranibizumab 0.3 mg or 0.5 mg intravitreal injections or monthly sham injections for 6 months.
At Month 6, after monthly treatment with 0.5 mg ranibizumab, the following clinical results were observed:
| Outcome Measure | Study * | Sham | Ranibizumab0.5 mg | Estimated Difference (95% CI) † |
|---|---|---|---|---|
| Gain of ≥15 letters in visual acuity (%) | RVO-1 | 29% | 61% | 31%(20%, 43%) |
| Gain of ≥15 letters in visual acuity (%) | RVO-2 | 17% | 48% | 30%(20%, 41%) |
| Figure 5. Mean Change in Visual Acuity from Baseline to Month 6 in Study RVO-1 and Study RVO-2 | |||||
| RVO-1: | RVO-2: | ||||
| Ranibizumab 0.5 mg (n=131) |
| Ranibizumab 0.5 mg (n=130) | ||
| Sham (n=132) |
| Sham (n=130) | ||
| p < 0.01 for all time points | |||||
14.3 Myopic Choroidal Neovascularization (mCNV)
The efficacy and safety data of ranibizumab were assessed in a randomized, double-masked, active-controlled 3- month study in patients with mCNV. Patients age ranged from 18 to 87 years, with a mean age of 55 years. A total of 276 patients (222 patients in the ranibizumab treated Groups I and II; 55 patients in the active control PDT group) were enrolled. Patients randomized to the ranibizumab groups received injections guided by pre- specified re-treatment criteria. The retreatment criteria in Group I were vision stability guided, with the Best Corrected Visual Acuity (BCVA) at the current visit being assessed for changes compared with the two preceding monthly BCVA values. The retreatment criteria in Group II were disease activity guided, based on BCVA decrease from the previous visit that was attributable to intra- or sub-retinal fluid or active leakage secondary to mCNV as assessed by OCT and/or FA compared to the previous monthly visit.
Visual gains for the two ranibizumab 0.5 mg treatment arms were superior to the active control arm. The mean change in BCVA from baseline at Month 3 was: +12.1 letters for Group I, +12.5 letters for Group II and +1.4 letters for the PDT group. (Figure 6; Table 6). Efficacy was comparable between Group I and Group II.
| Study Arms | Mean change in BCVA from baseline (Letters) | Proportion of patients who gained ≥15 letters from baseline | ||
|---|---|---|---|---|
| Mean (SD) | Estimated Difference (95% CI)* | Percent | Estimated Difference (95% CI)* | |
| ||||
| Group I | 12.1 (10.2) | 10.9(7.6, 14.3) | 37.1 | 22.6(9.5, 35.7) |
| Group II | 12.5 (8.8) | 11.4(8.3, 14.5) | 40.5 | 26.0(13.1, 38.9) |
| Control (PDT) | 1.4 (12.2) | 14.5 | ||
| Figure 6 Mean Change in Visual Acuity from Baseline to Month 3 in mCNV Study |
The proportion of patients who gained ≥15 letters (ETDRS) by Month 3 was 37.1% and 40.5% for ranibizumab Groups I and II, respectively and 14.5% for the PDT group. The mean number of injections between baseline and Month 3 was 2.5 and 1.8 for Groups I and II, respectively. 41% of patients received 1, 2 or 3 injections between baseline and Month 3 with no injections afterwards.
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