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.
Study Type
OBSERVATIONAL
Enrollment
110
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
...and 3 more locations
Number of Participants with Treatment Emergent Adverse Events (TEAEs), including Adverse Events of Special Interest (AESIs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The AESIs can include the following: cataracts, elevated IOP and conjunctival hemorrhage.
Time frame: Up to approximately 24 months
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