抄録
IMPORTANCE Polypoidal choroidal vasculopathy (PCV) is common in Asian populations, but an optimal treatment approach remains to be confirmed. OBJECTIVE To evaluate intravitreal aflibercept injection (IAI) in participants with PCV and compare IAI monotherapy with IAI plus rescue photodynamic therapy (PDT). DESIGN, SETTING, AND PARTICIPANTS This 96-week, double-masked, sham-controlled phase 3b/4 randomized clinical trial was conducted at multiple centers in Australia, Germany, Hong Kong, Hungary, Japan, Singapore, South Korea, and Taiwan from May 2014 to August 2016, and included adults 50 years or older with symptomatic macular PCV and a best-corrected visual acuity of 73 to 24 Early Treatment Diabetic Retinopathy Study letters (20/40-20/320 Snellen equivalent). INTERVENTIONS Participants received 2mg of IAI at weeks 0, 4, and 8. At week 12, participants with a suboptimal response were randomized 1:1 to receive IAI plus sham PDT (IAI monotherapy) or a "rescue" of IAI plus rescue PDT (IAI/PDT). Participants who did not qualify for rescue received IAI every 8 weeks; those qualifying for rescue received IAI every 4 weeks plus sham/active PDT. When the rescue criteria were no longer met, injection intervals were gradually extended to 8 weeks. MAIN OUTCOMES AND MEASURES Noninferiority of IAI monotherapy to IAI/PDT for mean change in best-corrected visual acuity from baseline to week 52 (95%CI of the difference entirely above-5 letters). RESULTS Of the 318 participants, the mean (SD) age was 70.6 (8.2) years, 96 (30.2%) were women, and 152 (47.8%) were Japanese. Monotherapy with IAI was noninferior to IAI/PDT for the primary end point (+10.7 vs +10.8 letters, respectively; 95%CI,-2.9 to 1.6; P =.55), with few participants requiring rescue therapy (19 [12.1%] vs 23 [14.3%], respectively). Participants in both treatment groups had similar reductions in central subfield thickness from baseline to week 52 (-137.7 [IAI monotherapy] vs-143.5 μm [IAI/PDT]). At week 52, 49 (38.9%) and 60 participants (44.8%) had no polypoidal lesions observed on indocyanine green angiography in the IAI monotherapy and IAI/PDT groups, respectively. Furthermore, 116 (81.7%) and 136 (88.9%), respectively, had no polypoidal lesions with leakage. The most frequent ocular adverse events were conjunctival hemorrhage (IAI monotherapy, 8 [5.1%]) and dry eye (IAI/PDT, 9 [5.6%]). CONCLUSIONS AND RELEVANCE Improvement in visual and/or functional outcomeswas achieved in more than 85%of participants who were treated with IAI monotherapy, with no signs of leakage from polypoidal lesions in more than 80%. As fewer than 15%met the criteria of a suboptimal response to receive PDT, the potential benefit of adding PDT cannot be determined.
| 元の言語 | 英語 |
|---|---|
| ページ（範囲） | 786-793 |
| ページ数 | 8 |
| ジャーナル | JAMA Ophthalmology |
| 巻 | 136 |
| 発行部数 | 7 |
| DOI | |
| 出版物ステータス | 出版済み - 7 1 2018 |
Fingerprint
All Science Journal Classification (ASJC) codes
- Ophthalmology
これを引用
Efficacy and safety of intravitreal aflibercept for polypoidal choroidal vasculopathy in the PLANET study a randomized clinical trial. / Lee, Won Ki; Iida, Tomohiro; Ogura, Yuichiro; Chen, Shih Jen; Wong, Tien Yin; Mitchell, Paul; Cheung, Gemmy Chui Ming; Zhang, Zhongqi; Leal, Sergio; Ishibashi, Tatsuro.
：: JAMA Ophthalmology, 巻 136, 番号 7, 01.07.2018, p. 786-793.研究成果: ジャーナルへの寄稿 › 記事
}
TY - JOUR
T1 - Efficacy and safety of intravitreal aflibercept for polypoidal choroidal vasculopathy in the PLANET study a randomized clinical trial
AU - Lee, Won Ki
AU - Iida, Tomohiro
AU - Ogura, Yuichiro
AU - Chen, Shih Jen
AU - Wong, Tien Yin
AU - Mitchell, Paul
AU - Cheung, Gemmy Chui Ming
AU - Zhang, Zhongqi
AU - Leal, Sergio
AU - Ishibashi, Tatsuro
PY - 2018/7/1
Y1 - 2018/7/1
N2 - IMPORTANCE Polypoidal choroidal vasculopathy (PCV) is common in Asian populations, but an optimal treatment approach remains to be confirmed. OBJECTIVE To evaluate intravitreal aflibercept injection (IAI) in participants with PCV and compare IAI monotherapy with IAI plus rescue photodynamic therapy (PDT). DESIGN, SETTING, AND PARTICIPANTS This 96-week, double-masked, sham-controlled phase 3b/4 randomized clinical trial was conducted at multiple centers in Australia, Germany, Hong Kong, Hungary, Japan, Singapore, South Korea, and Taiwan from May 2014 to August 2016, and included adults 50 years or older with symptomatic macular PCV and a best-corrected visual acuity of 73 to 24 Early Treatment Diabetic Retinopathy Study letters (20/40-20/320 Snellen equivalent). INTERVENTIONS Participants received 2mg of IAI at weeks 0, 4, and 8. At week 12, participants with a suboptimal response were randomized 1:1 to receive IAI plus sham PDT (IAI monotherapy) or a "rescue" of IAI plus rescue PDT (IAI/PDT). Participants who did not qualify for rescue received IAI every 8 weeks; those qualifying for rescue received IAI every 4 weeks plus sham/active PDT. When the rescue criteria were no longer met, injection intervals were gradually extended to 8 weeks. MAIN OUTCOMES AND MEASURES Noninferiority of IAI monotherapy to IAI/PDT for mean change in best-corrected visual acuity from baseline to week 52 (95%CI of the difference entirely above-5 letters). RESULTS Of the 318 participants, the mean (SD) age was 70.6 (8.2) years, 96 (30.2%) were women, and 152 (47.8%) were Japanese. Monotherapy with IAI was noninferior to IAI/PDT for the primary end point (+10.7 vs +10.8 letters, respectively; 95%CI,-2.9 to 1.6; P =.55), with few participants requiring rescue therapy (19 [12.1%] vs 23 [14.3%], respectively). Participants in both treatment groups had similar reductions in central subfield thickness from baseline to week 52 (-137.7 [IAI monotherapy] vs-143.5 μm [IAI/PDT]). At week 52, 49 (38.9%) and 60 participants (44.8%) had no polypoidal lesions observed on indocyanine green angiography in the IAI monotherapy and IAI/PDT groups, respectively. Furthermore, 116 (81.7%) and 136 (88.9%), respectively, had no polypoidal lesions with leakage. The most frequent ocular adverse events were conjunctival hemorrhage (IAI monotherapy, 8 [5.1%]) and dry eye (IAI/PDT, 9 [5.6%]). CONCLUSIONS AND RELEVANCE Improvement in visual and/or functional outcomeswas achieved in more than 85%of participants who were treated with IAI monotherapy, with no signs of leakage from polypoidal lesions in more than 80%. As fewer than 15%met the criteria of a suboptimal response to receive PDT, the potential benefit of adding PDT cannot be determined.
AB - IMPORTANCE Polypoidal choroidal vasculopathy (PCV) is common in Asian populations, but an optimal treatment approach remains to be confirmed. OBJECTIVE To evaluate intravitreal aflibercept injection (IAI) in participants with PCV and compare IAI monotherapy with IAI plus rescue photodynamic therapy (PDT). DESIGN, SETTING, AND PARTICIPANTS This 96-week, double-masked, sham-controlled phase 3b/4 randomized clinical trial was conducted at multiple centers in Australia, Germany, Hong Kong, Hungary, Japan, Singapore, South Korea, and Taiwan from May 2014 to August 2016, and included adults 50 years or older with symptomatic macular PCV and a best-corrected visual acuity of 73 to 24 Early Treatment Diabetic Retinopathy Study letters (20/40-20/320 Snellen equivalent). INTERVENTIONS Participants received 2mg of IAI at weeks 0, 4, and 8. At week 12, participants with a suboptimal response were randomized 1:1 to receive IAI plus sham PDT (IAI monotherapy) or a "rescue" of IAI plus rescue PDT (IAI/PDT). Participants who did not qualify for rescue received IAI every 8 weeks; those qualifying for rescue received IAI every 4 weeks plus sham/active PDT. When the rescue criteria were no longer met, injection intervals were gradually extended to 8 weeks. MAIN OUTCOMES AND MEASURES Noninferiority of IAI monotherapy to IAI/PDT for mean change in best-corrected visual acuity from baseline to week 52 (95%CI of the difference entirely above-5 letters). RESULTS Of the 318 participants, the mean (SD) age was 70.6 (8.2) years, 96 (30.2%) were women, and 152 (47.8%) were Japanese. Monotherapy with IAI was noninferior to IAI/PDT for the primary end point (+10.7 vs +10.8 letters, respectively; 95%CI,-2.9 to 1.6; P =.55), with few participants requiring rescue therapy (19 [12.1%] vs 23 [14.3%], respectively). Participants in both treatment groups had similar reductions in central subfield thickness from baseline to week 52 (-137.7 [IAI monotherapy] vs-143.5 μm [IAI/PDT]). At week 52, 49 (38.9%) and 60 participants (44.8%) had no polypoidal lesions observed on indocyanine green angiography in the IAI monotherapy and IAI/PDT groups, respectively. Furthermore, 116 (81.7%) and 136 (88.9%), respectively, had no polypoidal lesions with leakage. The most frequent ocular adverse events were conjunctival hemorrhage (IAI monotherapy, 8 [5.1%]) and dry eye (IAI/PDT, 9 [5.6%]). CONCLUSIONS AND RELEVANCE Improvement in visual and/or functional outcomeswas achieved in more than 85%of participants who were treated with IAI monotherapy, with no signs of leakage from polypoidal lesions in more than 80%. As fewer than 15%met the criteria of a suboptimal response to receive PDT, the potential benefit of adding PDT cannot be determined.
UR - http://www.scopus.com/inward/record.url?scp=85050893479&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85050893479&partnerID=8YFLogxK
U2 - 10.1001/jamaophthalmol.2018.1804
DO - 10.1001/jamaophthalmol.2018.1804
M3 - Article
VL - 136
SP - 786
EP - 793
JO - JAMA Ophthalmology
JF - JAMA Ophthalmology
SN - 2168-6165
IS - 7
ER -