Wykoff Charles C, Marcus Dennis M, Midena Edoardo, Korobelnik Jean-François, Saroj Namrata, Gibson Andrea, Vitti Robert, Berliner Alyson J, Williams Liu Zinaria, Zeitz Oliver, Metzig Carola, Schmelter Thomas, Heier Jeffrey S
Retina Consultants of Houston, Houston, Texas.
Southeast Retina Center, Augusta, Georgia.
JAMA Ophthalmol. 2017 Feb 1;135(2):107-114. doi: 10.1001/jamaophthalmol.2016.4912.
Information on the effect of anti-vascular endothelial growth factor therapy in eyes with diabetic macular edema (DME) with vision loss after macular laser photocoagulation is clinically valuable.
To evaluate visual and anatomic outcomes in a subgroup of macular laser photocoagulation treatment control (hereafter laser control) eyes with substantial vision loss receiving treatment with intravitreal aflibercept injection.
DESIGN, SETTING, AND PARTICIPANTS: This investigation was a post hoc analysis of a subgroup of laser control eyes in 2 phase 3 trials-VISTA (Study of Intravitreal Aflibercept Injection in Patients With Diabetic Macular Edema) and VIVID (Intravitreal Aflibercept Injection in Vision Impairment Due to DME)-in a multicenter setting. One hundred nine laser control eyes with center-involving DME were included.
Treatment with intravitreal aflibercept injection (2 mg) every 8 weeks after 5 monthly doses with sham injections on nontreatment visits starting at week 24 was initiated on meeting prespecified criteria of at least a 10-letter visual acuity loss at 2 consecutive visits or at least a 15-letter visual acuity loss from the best previous measurement at 1 visit and vision not better than at baseline.
Visual and anatomic outcomes in a subgroup of laser control eyes receiving treatment with intravitreal aflibercept injection.
Through week 100, a total of 63 of 154 eyes (40.9%) in VISTA and 46 of 133 eyes (34.6%) in VIVID initially randomized to laser control received treatment with intravitreal aflibercept injection. The median time from week 24 to the first intravitreal aflibercept injection treatment was 34.0 (VISTA) and 83.5 (VIVID) days. In this subgroup, the mean (SD) visual gain from baseline to week 100 was 2.2 (12.5) (VISTA) and 3.8 (10.1) (VIVID) letters. At the time of intravitreal aflibercept injection initiation, these eyes had a mean (SD) loss of 11.0 (10.1) (VISTA) and 10.0 (6.5) (VIVID) letters from baseline, and they subsequently gained a mean (SD) of 17.4 (9.7) (VISTA) and 13.6 (8.6) (VIVID) letters from the initiation of treatment with intravitreal aflibercept injection through week 100. There was a minimal mean change in central subfield thickness from baseline in these eyes at the time of intravitreal aflibercept injection initiation (an increase of 3.9 μm in VISTA and a decrease of 3.0 μm in VIVID), after which further mean (SD) reductions of 285.6 (202.6) μm (VISTA) and 313.4 (181.9) μm (VIVID) occurred through week 100.
Intravitreal aflibercept injection improves visual and anatomic outcomes in eyes experiencing substantial vision loss after macular laser photocoagulation treatment for DME.
clinicaltrials.gov Identifiers: NCT01363440 and NCT01331681.
关于抗血管内皮生长因子疗法对黄斑激光光凝术后视力丧失的糖尿病性黄斑水肿（DME）患者眼睛的影响的信息具有临床价值。
评估黄斑激光光凝治疗对照组（以下简称激光对照组）中视力严重丧失且接受玻璃体内阿柏西普注射治疗的亚组患者的视力和解剖学结局。
设计、地点和参与者：本研究是对两项3期试验——VISTA（糖尿病性黄斑水肿患者玻璃体内阿柏西普注射研究）和VIVID（DME导致视力损害的玻璃体内阿柏西普注射）——中激光对照组亚组进行的事后分析，研究在多中心开展。纳入了109只累及黄斑中心凹的DME激光对照组眼睛。
在符合预定标准（连续2次就诊时视力至少下降10个字母，或单次就诊时视力较之前最佳测量值至少下降15个字母且视力不比基线时更好）后，从第24周开始，在非治疗就诊时进行假注射，每月注射5次后，每8周进行一次玻璃体内阿柏西普注射（2毫克）治疗。
接受玻璃体内阿柏西普注射治疗的激光对照组亚组患者的视力和解剖学结局。
到第100周时，VISTA研究中最初随机分配至激光对照组的154只眼睛中有63只（40.9%）、VIVID研究中133只眼睛中有46只（34.6%）接受了玻璃体内阿柏西普注射治疗。从第24周到首次玻璃体内阿柏西普注射治疗的中位时间在VISTA研究中为34.0天，在VIVID研究中为83.5天。在该亚组中，从基线到第100周的平均（标准差）视力提高在VISTA研究中为2.2（12.5）个字母，在VIVID研究中为3.8（10.1）个字母。在开始玻璃体内阿柏西普注射时，这些眼睛相对于基线的平均（标准差）视力下降在VISTA研究中为11.0（10.1）个字母，在VIVID研究中为10.0（6.5）个字母，随后从开始玻璃体内阿柏西普注射治疗到第100周，平均（标准差）视力提高了17.4（9.7）个字母（VISTA研究）和13.6（8.6）个字母（VIVID研究）。在开始玻璃体内阿柏西普注射时，这些眼睛的中心子区域厚度相对于基线的平均变化最小（VISTA研究增加了3.9μm，VIVID研究减少了3.0μm），此后到第100周时平均（标准差）又进一步减少了285.6（202.6）μm（VISTA研究）和313.4（181.9）μm（VIVID研究）。
玻璃体内阿柏西普注射可改善DME黄斑激光光凝治疗后视力严重丧失患者眼睛的视力和解剖学结局。
clinicaltrials.gov标识符：NCT01363440和NCT01331681。
