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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OZURDEX | Participants with diabetic macular edema prescribed OZURDEX in routine clinical practice are observed from the first dose for up to 24 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 24 months |
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Inclusion Criteria:
- Participant scheduled to receive at least one intravitreal OZURDEX® injection for DME as per most current local approved label after its approval for DME in China.
Exclusion Criteria:
Concurrent participation in interventional clinical research that required treatment or use of an investigational agent.
Participants for whom OZURDEX® is contraindicated:
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Community sample: participants with diabetic macular edema (DME) who resided in China.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People'S Hospital /ID# 274505 | Beijing | Beijing Municipality | 100034 | China | ||
| Xiamen Eye Center of Xiamen University /ID# 268172 |
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| Xiamen |
| Fujian |
| 390000 |
| China |
| Zhongshan Ophthalmic Center,SunYat-Sen University /ID# 274555 | Guangzhou | Guangdong | 510623 | China |
| Henan Provincial Eye Hosptial /ID# 272424 | Zhengzhou | Henan | 450003 | China |
| General Hospital of Central Theater Command /ID# 273618 | Wuhan | Hubei | 430000 | China |
| The First Affiliated Hospital of Dalian Medical University /ID# 270563 | Dalian | Liaoning | 116000 | China |
| Xi'an Fourth Hospital /ID# 270562 | Xi'an | Shaanxi | 710004 | China |
| Qingdao Eye Hospital Of Shandong First Medical University /ID# 268173 | Qingdao | Shandong | 266071 | China |
| Shanghai General hospital /ID# 270376 | Shanghai | Shanghai Municipality | 200080 | China |
| West China Hospital of Sichuan University /ID# 273656 | Chengdu | Sichuan | 610041 | China |
| The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 273617 | Hangzhou | Zhejiang | 310009 | China |
| The Affiliated Eye Hospital Of Wenzhou Medical University /ID# 274466 | Wenzhou | Zhejiang | 325027 | China |
| Shanxi Eye Hospital /ID# 270564 | Taiyuan | 030072 | China |