Multicenter, Prospective, Randomized Study of Dexamethasone Intravitreal Implant in Patients with Center-Involved Diabetic Macular Edema in the Asia-Pacific Region.

Autor: Wei W; Beijing Tongren Hospital, Capital Medical University, Beijing, People's Republic of China., Chen Y; Peking Union Medical College Hospital, Beijing, People's Republic of China., Hu B; Tianjin Medical University Eye Hospital, Tianjin, People's Republic of China., Zhao M; Peking University People's Hospital, Beijing, People's Republic of China., Han M; Tianjin Eye Hospital, Tianjin, People's Republic of China., Dai H; Beijing Hospital, Beijing, People's Republic of China., Uy HS; Peregrine Eye and Laser Institute, Makati City, Philippines., Chen MY; Allergan, an AbbVie company, Irvine, CA, USA., Wang K; Allergan, an AbbVie company, Irvine, CA, USA., Jiao J; Allergan, an AbbVie company, Irvine, CA, USA., Lou J; Allergan, an AbbVie company, Irvine, CA, USA., Li XY; Allergan, an AbbVie company, Irvine, CA, USA.
Jazyk: angličtina
Zdroj: Clinical ophthalmology (Auckland, N.Z.) [Clin Ophthalmol] 2021 Oct 13; Vol. 15, pp. 4097-4108. Date of Electronic Publication: 2021 Oct 13 (Print Publication: 2021).
DOI: 10.2147/OPTH.S325618
Abstrakt: Purpose: 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 mm 2 with DEX versus -0.637 mm 2 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.
Competing Interests: Wenbin Wei, Youxin Chen, Bojie Hu, Mingwei Zhao, Mei Han, and Hong Dai have no financial relationships to disclose. Harvey S Uy has received research funding from and is a consultant for Allergan (an AbbVie company). Xian-Yan Li and Michelle Y Chen were employees of AbbVie at the time of this work. Kate Wang, Jenny Jiao, and Jean Lou are full-time employees of AbbVie Inc. The authors report no other conflicts of interest in this work. This work was presented in part at the Chinese Ophthalmological Society (COS) 25th Virtual Congress, November 19–22, 2020.
(© 2021 Wei et al.)
Databáze: MEDLINE
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