Multicenter, Prospective, Randomized Study of Dexamethasone Intravitreal Implant in Patients with Center-Involved Diabetic Macular Edema in the Asia-Pacific Region
Wenbin Wei,1 Youxin Chen,2 Bojie Hu,3 Mingwei Zhao,4 Mei Han,5 Hong Dai,6 Harvey S Uy,7 Michelle Y Chen,8 Kate Wang,8 Jenny Jiao,8 Jean Lou,8 Xiao-Yan Li8 1Beijing Tongren Hospital, Capital Medical University, Beijing, People’s Republic of China; 2Peking Union Medical College Hospital, Beijing, Peop...
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Dove Medical Press
2021
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oai:doaj.org-article:aa4455133bab4587a72758c3af0341832021-12-02T19:15:19ZMulticenter, Prospective, Randomized Study of Dexamethasone Intravitreal Implant in Patients with Center-Involved Diabetic Macular Edema in the Asia-Pacific Region1177-5483https://doaj.org/article/aa4455133bab4587a72758c3af0341832021-10-01T00:00:00Zhttps://www.dovepress.com/multicenter-prospective-randomized-study-of-dexamethasone-intravitreal-peer-reviewed-fulltext-article-OPTHhttps://doaj.org/toc/1177-5483Wenbin Wei,1 Youxin Chen,2 Bojie Hu,3 Mingwei Zhao,4 Mei Han,5 Hong Dai,6 Harvey S Uy,7 Michelle Y Chen,8 Kate Wang,8 Jenny Jiao,8 Jean Lou,8 Xiao-Yan Li8 1Beijing Tongren Hospital, Capital Medical University, Beijing, People’s Republic of China; 2Peking Union Medical College Hospital, Beijing, People’s Republic of China; 3Tianjin Medical University Eye Hospital, Tianjin, People’s Republic of China; 4Peking University People’s Hospital, Beijing, People’s Republic of China; 5Tianjin Eye Hospital, Tianjin, People’s Republic of China; 6Beijing Hospital, Beijing, People’s Republic of China; 7Peregrine Eye and Laser Institute, Makati City, Philippines; 8Allergan, an AbbVie company, Irvine, CA, USACorrespondence: Wenbin WeiBeijing Tongren Hospital, Capital Medical University, No. 1 Dongjiaominxiang, Dongcheng District, Beijing, 100730, People’s Republic of ChinaEmail tr_weiwenbin@163.comPurpose: To evaluate the safety and efficacy of dexamethasone intravitreal implant 0.7 mg (DEX) compared with laser photocoagulation in patients with diabetic macular edema (DME).Patients and Methods: This Phase 3, multicenter, randomized, efficacy evaluator–masked, parallel-group, 12-month clinical study enrolled adults in China and the Philippines with reduced visual acuity secondary to fovea-involved DME in the study eye. Participants were randomized 1:1 to study eye treatment with laser photocoagulation every 3 months as needed (n = 139) or DEX every 5 months (n = 145). The main efficacy measures were best-corrected visual acuity (BCVA), central retinal thickness (CRT), and leakage area. The primary endpoint was the average change in BCVA from baseline over 12 months (area-under-the-curve method). Preplanned subgroup analyses evaluated outcomes in Chinese patients.Results: Mean average change in BCVA from baseline during the study (letters) was 4.3 with DEX (n = 145) versus 1.4 with laser (n = 127) overall (P = 0.001) and 4.6 with DEX (n = 129) versus 0.6 with laser (n = 113) in Chinese patients (P < 0.001). At Month 12, mean change in CRT from baseline was − 209.5 μm with DEX versus − 120.3 μm with laser (P < 0.001) and mean change in total leakage area from baseline was − 8.367 mm2 with DEX versus − 0.637 mm2 with laser (P < 0.001). The most common treatment-emergent adverse events in the DEX group were increased intraocular pressure and cataract.Conclusion: DEX administered every 5 months provided significantly greater improvement in BCVA, CRT, and total leakage area compared with laser treatment. DEX demonstrated an acceptable safety profile, consistent with an intraocular corticosteroid, and similar to that reported in completed global registration studies.Keywords: central retinal thickness, corticosteroid, dexamethasone, diabetic retinopathy, drug delivery device, laser photocoagulation, randomized controlled trial, macular edema, visual acuityWei WChen YHu BZhao MHan MDai HUy HSChen MYWang KJiao JLou JLi XYDove Medical Pressarticlecentral retinal thicknesscorticosteroiddexamethasonediabetic retinopathydrug delivery devicelaser photocoagulationrandomized controlled trialmacular edemavisual acuityOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 15, Pp 4097-4108 (2021) |
| institution |
DOAJ |
| collection |
DOAJ |
| language |
EN |
| topic |
central retinal thickness corticosteroid dexamethasone diabetic retinopathy drug delivery device laser photocoagulation randomized controlled trial macular edema visual acuity Ophthalmology RE1-994 |
| spellingShingle |
central retinal thickness corticosteroid dexamethasone diabetic retinopathy drug delivery device laser photocoagulation randomized controlled trial macular edema visual acuity Ophthalmology RE1-994 Wei W Chen Y Hu B Zhao M Han M Dai H Uy HS Chen MY Wang K Jiao J Lou J Li XY Multicenter, Prospective, Randomized Study of Dexamethasone Intravitreal Implant in Patients with Center-Involved Diabetic Macular Edema in the Asia-Pacific Region |
| description |
Wenbin Wei,1 Youxin Chen,2 Bojie Hu,3 Mingwei Zhao,4 Mei Han,5 Hong Dai,6 Harvey S Uy,7 Michelle Y Chen,8 Kate Wang,8 Jenny Jiao,8 Jean Lou,8 Xiao-Yan Li8 1Beijing Tongren Hospital, Capital Medical University, Beijing, People’s Republic of China; 2Peking Union Medical College Hospital, Beijing, People’s Republic of China; 3Tianjin Medical University Eye Hospital, Tianjin, People’s Republic of China; 4Peking University People’s Hospital, Beijing, People’s Republic of China; 5Tianjin Eye Hospital, Tianjin, People’s Republic of China; 6Beijing Hospital, Beijing, People’s Republic of China; 7Peregrine Eye and Laser Institute, Makati City, Philippines; 8Allergan, an AbbVie company, Irvine, CA, USACorrespondence: Wenbin WeiBeijing Tongren Hospital, Capital Medical University, No. 1 Dongjiaominxiang, Dongcheng District, Beijing, 100730, People’s Republic of ChinaEmail tr_weiwenbin@163.comPurpose: To evaluate the safety and efficacy of dexamethasone intravitreal implant 0.7 mg (DEX) compared with laser photocoagulation in patients with diabetic macular edema (DME).Patients and Methods: This Phase 3, multicenter, randomized, efficacy evaluator–masked, parallel-group, 12-month clinical study enrolled adults in China and the Philippines with reduced visual acuity secondary to fovea-involved DME in the study eye. Participants were randomized 1:1 to study eye treatment with laser photocoagulation every 3 months as needed (n = 139) or DEX every 5 months (n = 145). The main efficacy measures were best-corrected visual acuity (BCVA), central retinal thickness (CRT), and leakage area. The primary endpoint was the average change in BCVA from baseline over 12 months (area-under-the-curve method). Preplanned subgroup analyses evaluated outcomes in Chinese patients.Results: Mean average change in BCVA from baseline during the study (letters) was 4.3 with DEX (n = 145) versus 1.4 with laser (n = 127) overall (P = 0.001) and 4.6 with DEX (n = 129) versus 0.6 with laser (n = 113) in Chinese patients (P < 0.001). At Month 12, mean change in CRT from baseline was − 209.5 μm with DEX versus − 120.3 μm with laser (P < 0.001) and mean change in total leakage area from baseline was − 8.367 mm2 with DEX versus − 0.637 mm2 with laser (P < 0.001). The most common treatment-emergent adverse events in the DEX group were increased intraocular pressure and cataract.Conclusion: DEX administered every 5 months provided significantly greater improvement in BCVA, CRT, and total leakage area compared with laser treatment. DEX demonstrated an acceptable safety profile, consistent with an intraocular corticosteroid, and similar to that reported in completed global registration studies.Keywords: central retinal thickness, corticosteroid, dexamethasone, diabetic retinopathy, drug delivery device, laser photocoagulation, randomized controlled trial, macular edema, visual acuity |
| format |
article |
| author |
Wei W Chen Y Hu B Zhao M Han M Dai H Uy HS Chen MY Wang K Jiao J Lou J Li XY |
| author_facet |
Wei W Chen Y Hu B Zhao M Han M Dai H Uy HS Chen MY Wang K Jiao J Lou J Li XY |
| author_sort |
Wei W |
| title |
Multicenter, Prospective, Randomized Study of Dexamethasone Intravitreal Implant in Patients with Center-Involved Diabetic Macular Edema in the Asia-Pacific Region |
| title_short |
Multicenter, Prospective, Randomized Study of Dexamethasone Intravitreal Implant in Patients with Center-Involved Diabetic Macular Edema in the Asia-Pacific Region |
| title_full |
Multicenter, Prospective, Randomized Study of Dexamethasone Intravitreal Implant in Patients with Center-Involved Diabetic Macular Edema in the Asia-Pacific Region |
| title_fullStr |
Multicenter, Prospective, Randomized Study of Dexamethasone Intravitreal Implant in Patients with Center-Involved Diabetic Macular Edema in the Asia-Pacific Region |
| title_full_unstemmed |
Multicenter, Prospective, Randomized Study of Dexamethasone Intravitreal Implant in Patients with Center-Involved Diabetic Macular Edema in the Asia-Pacific Region |
| title_sort |
multicenter, prospective, randomized study of dexamethasone intravitreal implant in patients with center-involved diabetic macular edema in the asia-pacific region |
| publisher |
Dove Medical Press |
| publishDate |
2021 |
| url |
https://doaj.org/article/aa4455133bab4587a72758c3af034183 |
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