The John and Liz Tory Eye Centre, Sunnybrook Health Sciences Center, and University of Toronto, Toronto, Canada.
Montreal Retina Institute, and McGill University, Montreal, Canada.
Ophthalmology. 2019 Jun;126(6):841-848. doi: 10.1016/j.ophtha.2019.01.013. Epub 2019 Jan 21.
To compare the efficacy of ranibizumab using a treat-and-extend (T&E) regimen with monthly dosing in treatment-naive patients with neovascular age-related macular degeneration (nAMD).
Prospective, randomized, open-label, multicenter, noninferiority, postauthorization study.
Treatment-naive patients with choroidal neovascularization secondary to AMD.
Patients with nAMD were randomized 1:1 to receive intravitreal ranibizumab at a dose of 0.5 mg in either a T&E or monthly dosing regimen. The noninferiority of T&E compared with the monthly dosing regimen was to be shown using a margin of 5 letters in best-corrected visual acuity (BCVA) improvement.
Mean change in BCVA in Early Treatment Diabetic Retinopathy Study letters from baseline to month 12.
Baseline and 12-month visual acuity data are available for 526 patients (T&E, n = 268; monthly, n = 258). At baseline, mean age was 78.8 years (standard deviation [SD], 7.8 years), 60.3% were women, and 94.3% were white. No significant between-group baseline differences were observed. The primary outcome of noninferiority regarding visual acuity was met with mean BCVA improvement of 8.4 letters (SD, 11.9 letters) and 6.0 letters (SD, 11.9 letters; P = 0.017) in the T&E and monthly regimens, respectively, with a between-group mean difference of 2.38 letters (95% confidence interval, 0.32-4.45 letters). Per protocol, a secondary analysis was performed to test for superiority of number of injections received up to month 12. This analysis demonstrated significantly fewer injections with T&E versus monthly dosing (9.4 and 11.8 injections, respectively), with a mean difference of -2.46 injections (95% confidence interval, -2.68 to -2.23 injections).
The 12-month results of this 2-year study demonstrated that regarding visual outcomes, the T&E regimen was noninferior to a monthly dosing regimen. Similar visual outcomes in the T&E group as in the monthly dosing group were achieved with significantly fewer injections.
比较治疗和扩展（T&E）方案与每月剂量方案在治疗初发性年龄相关性黄斑变性（nAMD）患者中的疗效。
前瞻性、随机、开放标签、多中心、非劣效性、上市后研究。
继发于 AMD 的脉络膜新生血管化的治疗初发性 nAMD 患者。
将 nAMD 患者随机 1:1 分为两组，分别接受玻璃体腔内雷珠单抗 0.5mg 治疗，T&E 组和每月剂量组。使用最佳矫正视力（BCVA）改善 5 个字母的差值来证明 T&E 与每月剂量方案相比的非劣效性。
从基线到第 12 个月时 BCVA 的平均变化，以早期治疗糖尿病视网膜病变研究字母表示。
526 例患者（T&E 组 n=268，每月组 n=258）可提供基线和 12 个月的视力数据。基线时，平均年龄为 78.8 岁（标准差 [SD]，7.8 岁），60.3%为女性，94.3%为白人。两组间无显著的基线差异。视力方面的主要非劣效性结果为，T&E 组和每月组的平均 BCVA 分别改善 8.4 个字母（SD，11.9 个字母）和 6.0 个字母（SD，11.9 个字母；P=0.017），两组间平均差异为 2.38 个字母（95%置信区间，0.32-4.45 个字母）。根据方案，进行了次要分析，以检验至第 12 个月时接受的注射次数的优势。该分析表明，T&E 组与每月剂量组相比，注射次数明显减少（分别为 9.4 次和 11.8 次），平均差异为-2.46 次（95%置信区间，-2.68 至-2.23 次）。
这项为期 2 年的研究的 12 个月结果表明，就视力结果而言，T&E 方案与每月剂量方案相比无劣效性。T&E 组与每月剂量组的视力结果相似，注射次数明显减少。
