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A Real-world Study to Assess Safety of OZURDEX® (Dexamethasone Intravitreal Implant) in Adult Participants With Diabetic Macular Edema in China
Sponsor: AbbVie
Summary
The dexamethasone intravitreal implant (OZURDEX) delivers dexamethasone gradually to the retina over time. It is an approved drug for the treatment of diabetic macular edema (DME). This study will assess the long-term safety and effectiveness of OZURDEX in adult participants with DME in the routine clinical setting in China. Approximately 110 participants who are prescribed OZURDEX by their physicians will be enrolled in multiple medical institutions in China where OZURDEX is used for DME in routine clinical practice. Participants will be followed for 24 months after the first administration of OZURDEX according to the routine clinical practice of the prescribing centers. A subsequent 30-day follow-up after the last dose will be performed to obtain information on any new or ongoing safety events and concomitant medications. No additional burden for participants in this trial is expected.
Official title: A Two-year Non-interventional, Real-world, Observational Study to Assess Safety of OZURDEX® (Dexamethasone Intravitreal Implant) in Patients With Diabetic Macular Edema in China
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
110
Start Date
2024-11-13
Completion Date
2027-04
Last Updated
2025-09-19
Healthy Volunteers
No
Conditions
Locations (13)
Peking University People'S Hospital /ID# 274505
Beijing, Beijing Municipality, China
Xiamen Eye Center of Xiamen University /ID# 268172
Xiamen, Fujian, China
Zhongshan Ophthalmic Center,SunYat-Sen University /ID# 274555
Guangzhou, Guangdong, China
Henan Provincial Eye Hosptial /ID# 272424
Zhengzhou, Henan, China
General Hospital of Central Theater Command /ID# 273618
Wuhan, Hubei, China
The First Affiliated Hospital of Dalian Medical University /ID# 270563
Dalian, Liaoning, China
Xi'an Fourth Hospital /ID# 270562
Xi'an, Shaanxi, China
Qingdao Eye Hospital Of Shandong First Medical University /ID# 268173
Qingdao, Shandong, China
Shanghai General hospital /ID# 270376
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University /ID# 273656
Chengdu, Sichuan, China
The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 273617
Hangzhou, Zhejiang, China
The Affiliated Eye Hospital Of Wenzhou Medical University /ID# 274466
Wenzhou, Zhejiang, China
Shanxi Eye Hospital /ID# 270564
Taiyuan, China