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Wei W, Chen Y, Hu B, et al. Multicenter, Prospective, Randomized Study of Dexamethasone Intravitreal Implant in Patients with Center-Involved Diabetic Macular Edema in the Asia-Pacific Region. Clin Ophthalmol. 2021;15:4097-4108doi: 10.2147/OPTH.S325618.
Wei, W., Chen, Y., Hu, B., Zhao, M., Han, M., Dai, H., Uy, H. S., Chen, M. Y., Wang, K., Jiao, J., Lou, J., & Li, X. Y. (2021). Multicenter, Prospective, Randomized Study of Dexamethasone Intravitreal Implant in Patients with Center-Involved Diabetic Macular Edema in the Asia-Pacific Region. Clinical ophthalmology (Auckland, N.Z.), 154097-4108. https://doi.org/10.2147/OPTH.S325618
Wei, Wenbin, et al. "Multicenter, Prospective, Randomized Study of Dexamethasone Intravitreal Implant in Patients with Center-Involved Diabetic Macular Edema in the Asia-Pacific Region." Clinical ophthalmology (Auckland, N.Z.) vol. 15 (2021): 4097-4108. doi: https://doi.org/10.2147/OPTH.S325618
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. Clin Ophthalmol. 2021 Oct 13;15:4097-4108. doi: 10.2147/OPTH.S325618. eCollection 2021. PMID: 34675477; PMCID: PMC8520964.
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Clin Ophthalmol. 2021 Oct 13;15:4097-4108. doi: 10.2147/OPTH.S325618. eCollection 2021.

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

Clinical ophthalmology (Auckland, N.Z.)

Wenbin Wei, Youxin Chen, Bojie Hu, Mingwei Zhao, Mei Han, Hong Dai, Harvey S Uy, Michelle Y Chen, Kate Wang, Jenny Jiao, Jean Lou, Xiao-Yan Li

Affiliations

  1. Beijing Tongren Hospital, Capital Medical University, Beijing, People's Republic of China.
  2. Peking Union Medical College Hospital, Beijing, People's Republic of China.
  3. Tianjin Medical University Eye Hospital, Tianjin, People's Republic of China.
  4. Peking University People's Hospital, Beijing, People's Republic of China.
  5. Tianjin Eye Hospital, Tianjin, People's Republic of China.
  6. Beijing Hospital, Beijing, People's Republic of China.
  7. Peregrine Eye and Laser Institute, Makati City, Philippines.
  8. Allergan, an AbbVie company, Irvine, CA, USA.

PMID: 34675477 PMCID: PMC8520964 DOI: 10.2147/OPTH.S325618

Abstract

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 (

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.

© 2021 Wei et al.

Keywords: central retinal thickness; corticosteroid; dexamethasone; diabetic retinopathy; drug delivery device; laser photocoagulation; macular edema; randomized controlled trial; visual acuity

Conflict of interest statement

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

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